Pancreatic CancerPhase 1/2NCT05070247

A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors

A Phase 1/2 study testing TAK-500, Pembrolizumab and Tocilizumab in people with Pancreatic Cancer and Hepatocellular Cancer, run by Takeda at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study is about TAK-500, given either alone or with pembrolizumab, in adults with select locally advanced or metastatic solid tumors. The aims of the study are: to assess the safety profile of TAK-500 when given alone and when given with pembrolizumab. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pancreatic Cancer, Hepatocellular Cancer, Mesothelioma
What is being tested?: TAK-500, Pembrolizumab and Tocilizumab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 12 sitesUnited States
Study dates: 14 Apr 2022to 6 Jan 2025
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Individuals with the following pathologically confirmed (cytological diagnosis is adequate) select locally advanced or metastatic solid tumors, whose disease has progressed on or are intolerant to standard therapy:
Gastroesophageal (esophageal, gastroesophageal junction, and gastric) adenocarcinoma, pancreatic adenocarcinoma, hepatocellular carcinoma (HCC), nonsquamous non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), mesothelioma, triple-negative breast cancer (TNBC), renal clear cell carcinoma (RCC) and nasopharyngeal carcinoma (NPC). Participants who are intolerant to all standard therapies are those who have developed clinical or laboratory abnormalities that prevent continued drug administration as evaluated by the principal investigator at the time of screening.
For dose expansion in 2L nonsquamous NSCLC (TAK-500 plus pembrolizumab):
Participants with pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic nonsquamous NSCLC.
Participants may not have a known targetable driver mutation, rearrangement or amplification (eg, EGFR, ALK, MET, ROS1, BRAF, KRASG12C, etc.).

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Must have had disease progression while on or following 1 prior line of therapy:
Disease progression while on or following at least 6 weeks of 1 prior anti-PD-(L)1 therapy in the recurrent locally advanced or metastatic setting. OR Disease progression/recurrence within 6 months of the completion of anti-PD-(L)1 therapy if administered in the adjuvant/neoadjuvant setting. Prior anti-PD-(L)1 therapy may have been given with or without an anti-CTLA4 antibody and/or chemotherapy (eg, carboplatin and pemetrexed).
Participants are eligible regardless of PD-L1 status.
For dose expansion in 3L nonsquamous NSCLC (TAK-500 SA):
Participants with pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic nonsquamous NSCLC.
Participants may not have a known targetable driver mutation, rearrangement or amplification (eg, EGFR, ALK, MET, ROS1, BRAF, KRASG12C, etc.).
Must have had disease progression while on or following 2 prior lines of therapy:
Disease progression while on or following at least 6 weeks of 1 prior anti-PD-(L)1 therapy in the recurrent locally advanced or metastatic setting OR Disease progression/recurrence within 6 months of the completion of 1 prior anti-PD-(L)1 therapy if administered in the adjuvant/neoadjuvant setting. Prior anti-PD-(L)1 therapy may have been given with or without an anti-CTLA4 antibody and/or chemotherapy (eg, carboplatin and pemetrexed).
Participants must have had disease progression while on or after 1 or 2 lines of chemotherapy in the recurrent locally advanced or metastatic setting. If the anti-PD-(L)1 therapy is given in combination with chemotherapy, participant must have progressed on an additional line of chemotherapy.
Participants are eligible regardless of PD-L1 status.
For dose expansion in 2L pancreatic adenocarcinoma (TAK-500 SA and TAK-500 plus pembrolizumab):
Participants with pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic pancreatic adenocarcinoma.
Must have had disease progression while on or following 1 prior line of therapy:
One prior line of fluorouracil- or gemcitabine-based chemotherapy (eg, FOLFIRINOX, FOLFOX, FOLFIRI, gemcitabine/nab-paclitaxel) in the metastatic/recurrent locally advanced setting. Prior chemotherapy in the neoadjuvant/adjuvant setting does not qualify unless the participant had progression of disease within 6 months of completion of neoadjuvant/adjuvant chemotherapy.
Must not have had prior exposure to anti-PD-(L)1 therapy.
Participants with MSI-H/dMMR disease are not eligible.
Participants are eligible regardless of PD-L1 status.
For dose expansion in 3L RCC (TAK-500 plus pembrolizumab):
Participants with pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic RCC.
Must have had disease progression while on or following 2 prior lines of therapy:
Disease progression while on or following at least 6 weeks of 1 prior anti-PD-(L)1 therapy in the recurrent locally advanced or metastatic setting. OR Disease progression/recurrence within 6 months of the completion of anti-PD-(L)1 therapy if administered in the adjuvant/neoadjuvant setting. Prior anti-PD-(L)1 therapy may have been given with or without an anti-CTLA4 antibody and/or an anti-VEGFR TKI.
Participants must have had prior therapy with 1 or 2 lines of VEGFR TKIs in the metastatic/recurrent locally advanced setting. If anti-PD-(L)1 therapy was given in combination with a VEGFR TKI, the participant must have had progressive disease on an additional line of therapy (eg, VEGFR TKI or VEGFR TKI-containing combination).
Participants are eligible regardless of PD-L1 status.
Must have at least 1 RECIST version 1.1 measurable lesion. Lesions in previously irradiated areas (or other local therapy) should not be selected as measurable/target lesions unless there has been demonstrated radiographic progression in that lesion. RECIST v1.1 target lesions must include at least 1 lesion that was not previously irradiated.
Adequate bone marrow, renal, and hepatic functions, as determined by the following laboratory parameters:
Absolute neutrophil count (ANC) greater than or equal to (>=) 1000/ microliter (mcL), platelet count >=75,000/mcL, and hemoglobin >= 8.0 grams per deciliter (g/dL) without growth factor support for ANC or transfusion support
Total bilirubin <=1.5 times the institutional upper limit of normal (ULN). For participants with Gilbert's disease or HCC, <=3 milligrams per deciliter (mg/dL).
Serum alanine aminotransferase and aspartate aminotransferase <=3.0*ULN or <=5.0*ULN with liver metastases or HCC.
Albumin >=3.0 g/dL.
Calculated creatinine clearance using the Cockcroft-Gault formula >=30 mL/minute.
Left ventricular ejection fraction (LVEF) >50%, as measured by echocardiogram or multiple gated acquisition scan (MUGA) within 4 weeks before receiving the first dose of study drug.
For participants with HCC only: Child-Pugh score less than or equal to 7 (Child-Pugh A or B7).
Clinically significant toxic effects of previous therapy have recovered to Grade 1 (per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 5.0) or baseline, except for alopecia, Grade 2 peripheral neuropathy, and/or autoimmune endocrinopathies with stable endocrine replacement therapy.
Participants previously treated with fully human/humanized antineoplastic monoclonal antibodies must not have received treatment with such antibodies for at least 4 weeks or the time period equal to the dosing interval, whichever is shorter. No washout period is required for prior treatment with pembrolizumab or other anti-programmed cell death protein 1 (PD-1) antibodies, although the first study dose of these drugs must not occur at an interval less than standard of care (that is, 3 weeks for 200 mg of IV pembrolizumab).

Who cannot join

History of any of the following <=6 months before first dose of study drug(s): congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, persistent hypertension >=160/100 millimeters of mercury (mmHg) despite optimal medical therapy, ongoing cardiac arrhythmias of Grade >2 (including atrial flutter/ fibrillation or intermittent ventricular tachycardia), other ongoing serious cardiac conditions (example, Grade 3 pericardial effusion or Grade 3 restrictive cardiomyopathy), or symptomatic cerebrovascular events. Chronic, stable atrial fibrillation on stable anticoagulation therapy, including low molecular-weight heparin, is allowed.
QT interval with Fridericia correction method >450 milliseconds (men) or >475 milliseconds (women) on a 12- lead ECG during the screening period.
Grade >=2 hypotension (that is, hypotension for which nonurgent intervention is required) at screening or during C1D1 predose assessment.
Oxygen saturation <92% on room air at screening or during C1D1 predose assessment.
Treatment with other STING agonists/antagonists, Toll-like receptor agonists or CCR2 agonist/antagonist within the past 6 months.
Active diagnosis of pneumonitis, interstitial lung disease, severe chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, other restrictive lung diseases, acute pulmonary embolism, or Grade >=2 pleural effusion not controlled by tap or requiring indwelling catheters.

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Grade >=2 fever of malignant origin.
Chronic, active hepatitis (example, participants with known hepatitis B surface antigen seropositive and/or detectable hepatitis C virus [HCV] RNA).
History of hepatic encephalopathy.
Prior or current clinically significant ascites, as measured by physical examination, that requires active paracentesis for control.
Treatment with any investigational products or other anticancer therapy (including chemotherapy, targeted agents, and immunotherapy), within 14 days or 5 half-lives, whichever is shorter, before C1D1 of study drug(s).
Radiation therapy within 14 days (42 days for radiation to the lungs) and/ or systemic treatment with radionuclides within 42 days before C1D1 of study drug(s). Participants with clinically relevant ongoing pulmonary complications from prior radiation therapy are not eligible.
Use of systemic corticosteroids or other immunosuppressive therapy, concurrently or within 14 days of C1D1 of study drug(s), with the following exceptions:
Topical, intranasal, inhaled, ocular, intra-articular, and/or other nonsystemic corticosteroids.
Physiological doses of replacement steroid therapy (example, for adrenal insufficiency), not to exceed the equivalent of 10 mg prednisone daily.
Recipients of allogeneic or autologous stem cell transplantation or organ transplantation.
Additional criteria specific for participants in TAK-500 and pembrolizumab combination arm only:
Contraindication to the administration of a pembrolizumab or prior intolerance to pembrolizumab or other anti-PD-1 or anti-programmed cell death protein ligand 1 antibody.
History of intolerance to any component of the study treatment agents or known serious or severe hypersensitivity reaction to any of the study drugs or their excipients. (Pembrolizumab is formulated with L-histidine, polysorbate 80, and sucrose.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

University of Colorado - Anschutz Medical Campus - PPDS
Aurora, Colorado, 80045
Univeristy of Alabama at Birmingham
Birmingham, Alabama, 35294
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Northwestern
Chicago, Illinois, 60611
Sarah Cannon Research Institute
Denver, Colorado, 80218
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
University of California San Diego
La Jolla, California, 92093
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Sarah Cannon Cancer Institute
Nashville, Tennessee, 37203
New York University
New York, New York, 10016-4744
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
START South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: An Open-label, Dose Escalation and Expansion, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of TAK-500, a Novel Stimulator of Interferon Genes Agonist, as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Select Locally Advanced or Metastatic Solid Tumors

This study is about TAK-500, given either alone or with pembrolizumab, in adults with select locally advanced or metastatic solid tumors.

The aims of the study are:

to assess the safety profile of TAK-500 when given alone and when given with pembrolizumab.
to assess the anti-tumor effects of TAK-500, when given alone and when given with pembrolizumab, in adults with locally advanced or metastatic solid tumors.

Participants may receive TAK-500 for up to 1 year. Participants may continue with their treatment if they have continuing benefit and if this is approved by their study doctor. Participants who are receiving TAK-500 either alone or with pembrolizumab will continue with their treatment until their disease progresses or until they or their study doctor decide they should stop this treatment.

Read the detailed description

The drug being tested in this study is called TAK-500. The study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of TAK-500 when used as a single agent (SA) and in combination with pembrolizumab in participants with locally advanced or metastatic solid tumors.

The study will be conducted in 2 phases: Dose Escalation and Dose Expansion Phase. The study will enroll approximately 313 participants (approximately 82 in the Dose Escalation Phase and approximately 231 in Dose Expansion Phase). The dose escalation phase will determine the recommended dose of TAK-500 along with the combination agents for the dose expansion phase. All the participants will be assigned to one of the 9 arms:

Dose Escalation: TAK-500 Single Agent (SA)
Dose Escalation: TAK-500 + Pembrolizumab
Dose Expansion: 2L NSCLC: TAK-500 recommended dose 1 for expansion (RDE 1) + Pembrolizumab
Dose Expansion: 2L NSCLC: TAK-500 recommended dose 2 for expansion (RDE 2) + Pembrolizumab
Dose Expansion: 3L NSCLC: TAK-500 (RDE 1) SA
Dose Expansion: 3L NSCLC: TAK-500 (RDE 2) SA
Dose Expansion: 2L Pancreatic Adenocarcinoma: TAK-500 (RDE 1) + Pembrolizumab
Dose Expansion: 2L Pancreatic Adeno: TAK-500 (RDE 1) SA
Dose Expansion: 3L RCC: TAK-500 (RDE 1) + Pembrolizumab

This multi-center trial will be conducted globally. Participants with demonstrated clinical benefit may continue treatment beyond 1 year if approved by the sponsor.

Conditions: Pancreatic Cancer, Hepatocellular Cancer, Mesothelioma, Breast Cancer, Gastric Cancer, Esophageal Cancer
Being tested: TAK-500, Pembrolizumab, Tocilizumab, Dexamethasone
Keywords: Drug Therapy
Medical subject headings: Pancreatic Neoplasms, Liver Neoplasms, Mesothelioma, Breast Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Nasopharyngeal Neoplasms, Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAK-500Drug
TAK-500 IV infusion.
PembrolizumabDrug
Pembrolizumab IV infusion.
TocilizumabDrug
Tocilizumab IV infusion.
DexamethasoneDrug
Dexamethasone IV infusion.
DexamethasoneDrug
Dexamethasone tablet.

Study groups in NCT05070247
Study group	Role	What they receive
Single Agent Dose Escalation: TAK-500 8 µg/kg	Experimental	Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year. Receives: Drug: TAK-500
Single Agent Dose Escalation: TAK-500 8 µg/kg + 1 TOCI	Experimental	Participants received premedication with 8 mg/kg tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. Receives: Drug: TAK-500; Drug: Tocilizumab
Single Agent Dose Escalation: TAK-500 16 µg/kg	Experimental	Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. Receives: Drug: TAK-500
Single Agent Dose Escalation: TAK-500 16 µg/kg + 1 DEX	Experimental	Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. Receives: Drug: TAK-500; Drug: Dexamethasone
Single Agent Dose Escalation: TAK-500 16 µg/kg + 2 DEX	Experimental	Participants received premedication with dexamethasone 10 mg tablets orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. Receives: Drug: TAK-500; Drug: Dexamethasone
Single Agent Dose Escalation: TAK-500 16 µg/kg + 1 TOCI	Experimental	Participants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year. Receives: Drug: TAK-500; Drug: Tocilizumab
Single Agent Dose Escalation: TAK-500 24 µg/kg + 2 DEX	Experimental	Participants received premedication with dexamethasone 10 mg tablets orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. Receives: Drug: TAK-500; Drug: Dexamethasone
Single Agent Dose Escalation: TAK-500 24 µg/kg + 1 TOCI	Experimental	Participants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year. Receives: Drug: TAK-500; Drug: Tocilizumab
Single Agent Dose Escalation: TAK-500 40 µg/kg + 2 DEX	Experimental	Participants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. Receives: Drug: TAK-500; Drug: Dexamethasone
Single Agent Dose Escalation: TAK-500 60 µg/kg + 2 DEX	Experimental	Participants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W for up to 1 year. Receives: Drug: TAK-500; Drug: Dexamethasone
Combination Dose Escalation: TAK-500 8 µg/kg + 1 TOCI + Pembrolizumab	Experimental	Participants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W , for up to 1 year, along with pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year. Receives: Drug: TAK-500; Drug: Pembrolizumab; Drug: Tocilizumab
Combination Dose Escalation: TAK-500 16 µg/kg + Pembrolizumab + 1 TOCI	Experimental	Participants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W , for up to 1 year, along with pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle Q3W for up to 1 year. Receives: Drug: TAK-500; Drug: Pembrolizumab; Drug: Tocilizumab
Combination Dose Escalation: TAK 500 24 µg/kg + Pembrolizumab + 2 DEX	Experimental	Participants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year along with pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle Q3W for up to 1 year. Receives: Drug: TAK-500; Drug: Pembrolizumab; Drug: Dexamethasone
Combination Dose Escalation: TAK-500 40 µg/kg + Pembrolizumab + 2 DEX	Experimental	Participants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year along with pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle Q3W for up to 1 year. Receives: Drug: TAK-500; Drug: Pembrolizumab; Drug: Dexamethasone
Dose Expansion: TAK-500	Experimental	Participants were planned to receive TAK-500 at recommended doses based on dose escalation cohorts. No participants were enrolled in the expansion phase due to early termination of the study before initiating this phase. Receives: Drug: TAK-500

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose Escalation: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).
Measured: Up to approximately 32.8 months
Dose Escalation: Number of Participants With Grade 3 or Higher TEAEs
AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). TEAE Grades was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Measured: Up to approximately 32.8 months
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
DLT was defined as any of the TEAEs that occur during Cycle 1 and are considered by the investigator to be at least possibly related to TAK-500 as a SA or in combination with pembrolizumab. Toxicity will be evaluated according to NCI CTCAE version 5.0.
Measured: Up to Cycle 1 (1 cycle = 21 days)
Dose Escalation: Number of Participants Reporting One or More Treatment-emergent Serious Adverse Events (SAEs)
A TEAE is an AE for which the date of onset was on or after the first dose of any study drug and on or before 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). Treatment-emergent SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.
Measured: Up to approximately 32.8 months
Dose Escalation: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations
AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).
Measured: Up to approximately 32.8 months
Dose Expansion: Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieve confirmed partial response (cPR) or confirmed complete response (cCR) (determined by the investigator) during the study in the response-evaluable population. ORR will be assessed as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Complete response (CR): defined as disappearance of all target and non- target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than <10 mm. Partial response (PR): defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. cPR or cCR is defined as a PR or CR that is confirmed with additional imaging 6 weeks after initial response.
Measured: Up to approximately 32.8 months

Secondary outcomes (20)

Dose Escalation: Cmax: Maximum Serum Concentration for TAK-500
Measured: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)
Dose Escalation: Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAK-500
Measured: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)
Dose Escalation: AUCt: Area Under the Serum Concentration-time Curve From Time 0 to Time t for TAK-500
Measured: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)
Dose Escalation: AUCinf: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-500
Measured: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)
Dose Escalation: t1/2: Terminal Disposition Phase Half-life for TAK-500
Measured: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)
Dose Escalation: CL: Total Clearance After Intravenous Administration for TAK-500
Measured: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)
Dose Escalation: Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-500
Measured: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)
Dose Escalation: Changes in Intratumoral Tumor Cell Infiltration
Measurement of changes in tumor immune cell infiltration were measured by immunohistochemistry on fresh tumor biopsies taken pre and post treatment (up to 23 days after first administration of TAK-500) for each participant.
Measured: Up to 23 days after first administration of TAK-500
Dose Escalation: Number of Participants With Positive Anti-drug Antibody (ADA) (Acquired Immunogenicity)
Number of participants with positive ADA at any scheduled post-baseline visit are reported.
Measured: Up to approximately 32.8 months
Dose Escalation: Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieve cPR or cCR (determined by the investigator) during the study in the response-evaluable population. ORR will be assessed as per RECIST Version 1.1. CR: defined as disappearance of all target and non- target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than <10 mm. PR: defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. cPR or cCR is defined as a PR or CR that is confirmed with additional imaging 6 weeks after initial response.
Measured: Up to approximately 32.8 months
Dose Escalation: Disease Control Rate (DCR)
DCR is defined as the percentage of participants who achieve cCR + cPR + stable disease (SD) or better (determined by the investigator) greater than (>) 6 weeks during the study in the response-evaluable population. DCR will be assessed as per RECIST Version 1.1. CR: disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: at least a 20% increase in the sum of diameters of target lesions.
Measured: Up to approximately 32.8 months
Dose Escalation: Duration of Response (DOR)
DOR is defined as the time from the date of first documentation of a cPR or better to the date of first documentation of PD for responders (cPR or better). Responders without documentation of PD will be censored at the date of last response assessment that is SD or better. DOR will be assessed as per RECIST Version 1.1. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: at least a 20% increase in the sum of diameters of target lesions.
Measured: Up to approximately 32.8 months
Dose Escalation: Time to Response (TTR)
TTR is defined as the time from the date of first dose administration to the date of first documented cPR or better (determined by the investigator) in the safety population. TTR will be assessed as per RECIST Version 1.1. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.
Measured: Up to approximately 32.8 months
Dose Expansion: Progression Free Survival (PFS)
PFS is defined as the time from date of study treatment to the first documented PD based on RECIST v.1.1, or death due to any cause, whichever occurs first. PD: at least a 20% increase in the sum of diameters of target lesions.
Measured: Up to approximately 32.8 months
Dose Expansion: Overall Survival (OS)
OS is defined as the time from the date of first dose administration to the date of death.
Measured: Up to approximately 32.8 months
Dose Expansion: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).
Measured: Up to approximately 32.8 months
Dose Expansion: Number of Participants With Grade 3 or Higher TEAEs
AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). TEAE Grades will be evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Measured: Up to approximately 32.8 months
Dose Expansion: Number of Participants With Dose Limiting Toxicities (DLTs)
DLT will be defined as any of the TEAEs that occur during Cycle 1 and are considered by the investigator to be at least possibly related to TAK-500 as a SA or in combination with pembrolizumab. Toxicity will be evaluated according to NCI CTCAE version 5.0.
Measured: Up to approximately 32.8 months
Dose Expansion: Number of Participants Reporting One or More Treatment-emergent SAEs
Measured: Up to approximately 32.8 months
Dose Expansion: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations
AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).
Measured: Up to approximately 32.8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Apr 20226 Jan 2025

First posted7 Oct 2021
Study start14 Apr 2022
Primary completion6 Jan 2025
Study completion6 Jan 2025

Why it stopped: Clinical Futility of TAK 500 met. No further development with this compound

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pancreatic CancerStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05070247
Sponsor's protocol ID: TAK-500-1001
Status last verified: Jan 2026
First submitted: 24 Sep 2021
Last updated: 22 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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Questions to ask the study team

What is the study trying to find out?
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Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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All Pancreatic Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Dose Escalation and Expansion, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of TAK-500, a Novel Stimulator of Interferon Genes Agonist, as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Select Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT05070247
Acronym / sponsor ID: TAK-500-1001
Conditions: Pancreatic Cancer, Hepatocellular Cancer, Mesothelioma, Breast Cancer, Gastric Cancer, Esophageal Cancer
Keywords: Drug Therapy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Clinical Futility of TAK 500 met. No further development with this compound
Enrolment: 61 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 14 Apr 2022 (actual)
Primary completion: 6 Jan 2025 (actual)
Study completion: 6 Jan 2025 (actual)
First posted: 7 Oct 2021 (actual)
Results: Posted 22 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is about TAK-500, given either alone or with pembrolizumab, in adults with select locally advanced or metastatic solid tumors.

The aims of the study are:

to assess the safety profile of TAK-500 when given alone and when given with pembrolizumab.
to assess the anti-tumor effects of TAK-500, when given alone and when given with pembrolizumab, in adults with locally advanced or metastatic solid tumors.

Detailed description

Dose Escalation: TAK-500 Single Agent (SA)
Dose Escalation: TAK-500 + Pembrolizumab
Dose Expansion: 2L NSCLC: TAK-500 recommended dose 1 for expansion (RDE 1) + Pembrolizumab
Dose Expansion: 2L NSCLC: TAK-500 recommended dose 2 for expansion (RDE 2) + Pembrolizumab
Dose Expansion: 3L NSCLC: TAK-500 (RDE 1) SA
Dose Expansion: 3L NSCLC: TAK-500 (RDE 2) SA
Dose Expansion: 2L Pancreatic Adenocarcinoma: TAK-500 (RDE 1) + Pembrolizumab
Dose Expansion: 2L Pancreatic Adeno: TAK-500 (RDE 1) SA
Dose Expansion: 3L RCC: TAK-500 (RDE 1) + Pembrolizumab

This multi-center trial will be conducted globally. Participants with demonstrated clinical benefit may continue treatment beyond 1 year if approved by the sponsor.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 15

Arm	Type	Receives
Single Agent Dose Escalation: TAK-500 8 µg/kg	Experimental	Drug: TAK-500Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
Single Agent Dose Escalation: TAK-500 8 µg/kg + 1 TOCI	Experimental	Drug: TAK-500, Drug: TocilizumabParticipants received premedication with 8 mg/kg tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
Single Agent Dose Escalation: TAK-500 16 µg/kg	Experimental	Drug: TAK-500Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
Single Agent Dose Escalation: TAK-500 16 µg/kg + 1 DEX	Experimental	Drug: TAK-500, Drug: DexamethasoneParticipants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
Single Agent Dose Escalation: TAK-500 16 µg/kg + 2 DEX	Experimental	Drug: TAK-500, Drug: DexamethasoneParticipants received premedication with dexamethasone 10 mg tablets orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
Single Agent Dose Escalation: TAK-500 16 µg/kg + 1 TOCI	Experimental	Drug: TAK-500, Drug: TocilizumabParticipants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year.
Single Agent Dose Escalation: TAK-500 24 µg/kg + 2 DEX	Experimental	Drug: TAK-500, Drug: DexamethasoneParticipants received premedication with dexamethasone 10 mg tablets orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
Single Agent Dose Escalation: TAK-500 24 µg/kg + 1 TOCI	Experimental	Drug: TAK-500, Drug: TocilizumabParticipants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year.
Single Agent Dose Escalation: TAK-500 40 µg/kg + 2 DEX	Experimental	Drug: TAK-500, Drug: DexamethasoneParticipants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
Single Agent Dose Escalation: TAK-500 60 µg/kg + 2 DEX	Experimental	Drug: TAK-500, Drug: DexamethasoneParticipants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W for up to 1 year.
Combination Dose Escalation: TAK-500 8 µg/kg + 1 TOCI + Pembrolizumab	Experimental	Drug: TAK-500, Drug: Pembrolizumab, Drug: TocilizumabParticipants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W , for up to 1 year, along with pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year.
Combination Dose Escalation: TAK-500 16 µg/kg + Pembrolizumab + 1 TOCI	Experimental	Drug: TAK-500, Drug: Pembrolizumab, Drug: TocilizumabParticipants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W , for up to 1 year, along with pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle Q3W for up to 1 year.
Combination Dose Escalation: TAK 500 24 µg/kg + Pembrolizumab + 2 DEX	Experimental	Drug: TAK-500, Drug: Pembrolizumab, Drug: DexamethasoneParticipants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year along with pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle Q3W for up to 1 year.
Combination Dose Escalation: TAK-500 40 µg/kg + Pembrolizumab + 2 DEX	Experimental	Drug: TAK-500, Drug: Pembrolizumab, Drug: DexamethasoneParticipants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year along with pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle Q3W for up to 1 year.
Dose Expansion: TAK-500	Experimental	Drug: TAK-500Participants were planned to receive TAK-500 at recommended doses based on dose escalation cohorts. No participants were enrolled in the expansion phase due to early termination of the study before initiating this phase.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (40 listed)

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Individuals with the following pathologically confirmed (cytological diagnosis is adequate) select locally advanced or metastatic solid tumors, whose disease has progressed on or are intolerant to standard therapy:
Must have at least 1 RECIST version 1.1 measurable lesion. Lesions in previously irradiated areas (or other local therapy) should not be selected as measurable/target lesions unless there has been demonstrated radiographic progression in that lesion. RECIST v1.1 target lesions must include at least 1 lesion that was not previously irradiated.
Adequate bone marrow, renal, and hepatic functions, as determined by the following laboratory parameters:
Left ventricular ejection fraction (LVEF) >50%, as measured by echocardiogram or multiple gated acquisition scan (MUGA) within 4 weeks before receiving the first dose of study drug.

Key exclusion criteria (19 listed)

History of any of the following <=6 months before first dose of study drug(s): congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, persistent hypertension >=160/100 millimeters of mercury (mmHg) despite optimal medical therapy, ongoing cardiac arrhythmias of Grade >2 (including atrial flutter/ fibrillation or intermittent ventricular tachycardia), other ongoing serious cardiac conditions (example, Grade 3 pericardial effusion or Grade 3 restrictive cardiomyopathy), or symptomatic cerebrovascular events. Chronic, stable atrial fibrillation on stable anticoagulation therapy, including low molecular-weight heparin, is allowed.
QT interval with Fridericia correction method >450 milliseconds (men) or >475 milliseconds (women) on a 12- lead ECG during the screening period.
Grade >=2 hypotension (that is, hypotension for which nonurgent intervention is required) at screening or during C1D1 predose assessment.
Oxygen saturation <92% on room air at screening or during C1D1 predose assessment.
Treatment with other STING agonists/antagonists, Toll-like receptor agonists or CCR2 agonist/antagonist within the past 6 months.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAK-500TAK-500 IV infusion.	Drug	Combination Dose Escalation: TAK 500 24 µg/kg + Pembrolizumab + 2 DEX, Combination Dose Escalation: TAK-500 16 µg/kg + Pembrolizumab + 1 TOCI, Combination Dose Escalation: TAK-500 40 µg/kg + Pembrolizumab + 2 DEX, Combination Dose Escalation: TAK-500 8 µg/kg + 1 TOCI + Pembrolizumab, Dose Expansion: TAK-500, Single Agent Dose Escalation: TAK-500 16 µg/kg, Single Agent Dose Escalation: TAK-500 16 µg/kg + 1 DEX, Single Agent Dose Escalation: TAK-500 16 µg/kg + 1 TOCI, Single Agent Dose Escalation: TAK-500 16 µg/kg + 2 DEX, Single Agent Dose Escalation: TAK-500 24 µg/kg + 1 TOCI, Single Agent Dose Escalation: TAK-500 24 µg/kg + 2 DEX, Single Agent Dose Escalation: TAK-500 40 µg/kg + 2 DEX, Single Agent Dose Escalation: TAK-500 60 µg/kg + 2 DEX, Single Agent Dose Escalation: TAK-500 8 µg/kg, Single Agent Dose Escalation: TAK-500 8 µg/kg + 1 TOCI
PembrolizumabPembrolizumab IV infusion.	Drug	Combination Dose Escalation: TAK 500 24 µg/kg + Pembrolizumab + 2 DEX, Combination Dose Escalation: TAK-500 16 µg/kg + Pembrolizumab + 1 TOCI, Combination Dose Escalation: TAK-500 40 µg/kg + Pembrolizumab + 2 DEX, Combination Dose Escalation: TAK-500 8 µg/kg + 1 TOCI + Pembrolizumab
TocilizumabTocilizumab IV infusion.	Drug	Combination Dose Escalation: TAK-500 16 µg/kg + Pembrolizumab + 1 TOCI, Combination Dose Escalation: TAK-500 8 µg/kg + 1 TOCI + Pembrolizumab, Single Agent Dose Escalation: TAK-500 16 µg/kg + 1 TOCI, Single Agent Dose Escalation: TAK-500 24 µg/kg + 1 TOCI, Single Agent Dose Escalation: TAK-500 8 µg/kg + 1 TOCI
DexamethasoneDexamethasone IV infusion.	Drug	Combination Dose Escalation: TAK 500 24 µg/kg + Pembrolizumab + 2 DEX, Combination Dose Escalation: TAK-500 40 µg/kg + Pembrolizumab + 2 DEX, Single Agent Dose Escalation: TAK-500 16 µg/kg + 1 DEX, Single Agent Dose Escalation: TAK-500 16 µg/kg + 2 DEX, Single Agent Dose Escalation: TAK-500 24 µg/kg + 2 DEX, Single Agent Dose Escalation: TAK-500 40 µg/kg + 2 DEX, Single Agent Dose Escalation: TAK-500 60 µg/kg + 2 DEX
DexamethasoneDexamethasone tablet.	Drug	Combination Dose Escalation: TAK 500 24 µg/kg + Pembrolizumab + 2 DEX, Combination Dose Escalation: TAK-500 40 µg/kg + Pembrolizumab + 2 DEX, Single Agent Dose Escalation: TAK-500 16 µg/kg + 2 DEX, Single Agent Dose Escalation: TAK-500 24 µg/kg + 2 DEX, Single Agent Dose Escalation: TAK-500 40 µg/kg + 2 DEX, Single Agent Dose Escalation: TAK-500 60 µg/kg + 2 DEX

Primary outcome

Dose Escalation: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 32.8 months
Adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).
Dose Escalation: Number of Participants With Grade 3 or Higher TEAEs
Time frame: Up to approximately 32.8 months
AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). TEAE Grades was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Up to Cycle 1 (1 cycle = 21 days)
DLT was defined as any of the TEAEs that occur during Cycle 1 and are considered by the investigator to be at least possibly related to TAK-500 as a SA or in combination with pembrolizumab. Toxicity will be evaluated according to NCI CTCAE version 5.0.
Dose Escalation: Number of Participants Reporting One or More Treatment-emergent Serious Adverse Events (SAEs)
Time frame: Up to approximately 32.8 months
A TEAE is an AE for which the date of onset was on or after the first dose of any study drug and on or before 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). Treatment-emergent SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.
Dose Escalation: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations
Time frame: Up to approximately 32.8 months
AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).
Dose Expansion: Overall Response Rate (ORR)
Time frame: Up to approximately 32.8 months
ORR is defined as the percentage of participants who achieve confirmed partial response (cPR) or confirmed complete response (cCR) (determined by the investigator) during the study in the response-evaluable population. ORR will be assessed as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Complete response (CR): defined as disappearance of all target and non- target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than <10 mm. Partial response (PR): defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. cPR or cCR is defined as a PR or CR that is confirmed with additional imaging 6 weeks after initial response.

20 secondary outcomes

Dose Escalation: Cmax: Maximum Serum Concentration for TAK-500
Time frame: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)
Dose Escalation: Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAK-500
Time frame: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)
Dose Escalation: AUCt: Area Under the Serum Concentration-time Curve From Time 0 to Time t for TAK-500
Time frame: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)
Dose Escalation: AUCinf: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-500
Time frame: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)
Dose Escalation: t1/2: Terminal Disposition Phase Half-life for TAK-500
Time frame: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)
Dose Escalation: CL: Total Clearance After Intravenous Administration for TAK-500
Time frame: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)
Dose Escalation: Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-500
Time frame: Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)
Dose Escalation: Changes in Intratumoral Tumor Cell Infiltration
Time frame: Up to 23 days after first administration of TAK-500
Dose Escalation: Number of Participants With Positive Anti-drug Antibody (ADA) (Acquired Immunogenicity)
Time frame: Up to approximately 32.8 months
Dose Escalation: Overall Response Rate (ORR)
Time frame: Up to approximately 32.8 months
Dose Escalation: Disease Control Rate (DCR)
Time frame: Up to approximately 32.8 months
Dose Escalation: Duration of Response (DOR)
Time frame: Up to approximately 32.8 months
Dose Escalation: Time to Response (TTR)
Time frame: Up to approximately 32.8 months
Dose Expansion: Progression Free Survival (PFS)
Time frame: Up to approximately 32.8 months
Dose Expansion: Overall Survival (OS)
Time frame: Up to approximately 32.8 months
Dose Expansion: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 32.8 months
Dose Expansion: Number of Participants With Grade 3 or Higher TEAEs
Time frame: Up to approximately 32.8 months
Dose Expansion: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Up to approximately 32.8 months
Dose Expansion: Number of Participants Reporting One or More Treatment-emergent SAEs
Time frame: Up to approximately 32.8 months
Dose Expansion: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations
Time frame: Up to approximately 32.8 months

Results and safety

Results posted to the registry on 22 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Agent Dose Escalation: TAK-500 8 µg/kg	3	1
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg	3	1
Single Agent Dose Escalation: TAK-500 16 µg/kg	5	1
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg	3	1
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg	3	3
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg	7	1
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg	3	2
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg	2	0
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg	6	1
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg	4	1
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg	5	1
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg	5	1
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg	7	1
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg	5	1
Dose Expansion: TAK-500	0	0

Primary outcome: Dose Escalation: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

Time frame: Up to approximately 32.8 months. Count of participants. Unit: Participants

Measure	Single Agent Dose Escalation: TAK-500 8 µg/kg n = 3	Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg n = 3	Single Agent Dose Escalation: TAK-500 16 µg/kg n = 5	Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg n = 3	Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg n = 3	Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg n = 7	Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg n = 3	Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg n = 2	Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg n = 6	Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg n = 4	Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg n = 5	Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg n = 5	Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg n = 7	Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg n = 5
Value	3	3	5	3	3	7	3	2	6	4	5	5	7	5

Population analysed: Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab).

Primary outcome: Dose Escalation: Number of Participants With Grade 3 or Higher TEAEs

Time frame: Up to approximately 32.8 months. Count of participants. Unit: Participants

Measure	Single Agent Dose Escalation: TAK-500 8 µg/kg n = 3	Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg n = 3	Single Agent Dose Escalation: TAK-500 16 µg/kg n = 5	Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg n = 3	Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg n = 3	Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg n = 7	Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg n = 3	Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg n = 2	Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg n = 6	Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg n = 4	Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg n = 5	Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg n = 5	Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg n = 7	Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg n = 5
Value	2	3	2	2	2	5	3	2	3	4	4	3	4	4

Population analysed: Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab).

Primary outcome: Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)

Time frame: Up to Cycle 1 (1 cycle = 21 days). Count of participants. Unit: Participants

Measure	Single Agent Dose Escalation: TAK-500 8 µg/kg n = 3	Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg n = 3	Single Agent Dose Escalation: TAK-500 16 µg/kg n = 5	Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg n = 3	Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg n = 3	Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg n = 7	Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg n = 3	Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg n = 2	Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg n = 6	Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg n = 4	Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg n = 5	Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg n = 5	Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg n = 6	Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg n = 5
Value	0	0	0	0	0	0	0	2	0	2	0	0	0	2

Population analysed: The DLT-evaluable analysis set included participants who received all required doses of TAK-500 (with pembrolizumab if in a combination cohort) and remain on study for 21 days from first dosing of TAK-500 (through C1D21) without experiencing a DLT or who have a DLT during the first 21 days after study drug administration.

Primary outcome: Dose Escalation: Number of Participants Reporting One or More Treatment-emergent Serious Adverse Events (SAEs)

Time frame: Up to approximately 32.8 months. Count of participants. Unit: Participants

Measure	Single Agent Dose Escalation: TAK-500 8 µg/kg n = 3	Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg n = 3	Single Agent Dose Escalation: TAK-500 16 µg/kg n = 5	Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg n = 3	Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg n = 3	Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg n = 7	Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg n = 3	Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg n = 2	Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg n = 6	Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg n = 4	Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg n = 5	Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg n = 5	Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg n = 7	Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg n = 5
Value	3	3	4	2	2	5	2	2	3	4	3	4	6	4

Population analysed: Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab).

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to approximately 32.8 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Agent Dose Escalation: TAK-500 8 µg/kg	3 of 3 (100%)	3 of 3 (100%)	1 of 3
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg	3 of 3 (100%)	3 of 3 (100%)	1 of 3
Single Agent Dose Escalation: TAK-500 16 µg/kg	4 of 5 (80%)	5 of 5 (100%)	1 of 5
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg	2 of 3 (66.7%)	3 of 3 (100%)	1 of 3
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg	5 of 7 (71.4%)	7 of 7 (100%)	2 of 7
Single Agent Dose Escalation: TAK-500 24 µg/kg + 2 DEX	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg	2 of 2 (100%)	2 of 2 (100%)	0 of 2
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg	3 of 6 (50%)	6 of 6 (100%)	2 of 6
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg	4 of 4 (100%)	4 of 4 (100%)	1 of 4
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg	3 of 5 (60%)	5 of 5 (100%)	2 of 5
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg	4 of 5 (80%)	5 of 5 (100%)	2 of 5
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg	6 of 7 (85.7%)	7 of 7 (100%)	2 of 7
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg	4 of 5 (80%)	5 of 5 (100%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain more information on the study, click here/on this linkLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TAK-500, Pembrolizumab and Tocilizumab in people with Pancreatic Cancer and Hepatocellular Cancer, run by Takeda at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 40 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Escalation: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) (time frame: Up to approximately 32.8 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05070247.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.