Advanced Malignant Solid NeoplasmPhase 2NCT04171219
Talabostat and Pembrolizumab for the Treatment of Advanced Solid Cancers
A Phase 2 study testing Pembrolizumab and Talabostat Mesylate in people with Advanced Malignant Solid Neoplasm and Recurrent Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies the side effects of talabostat and pembrolizumab and to see how well they work for the treatment of solid cancers that have spread to other places in the body (advanced). Talabostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Advanced Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm
- What is being tested?
- Pembrolizumab and Talabostat Mesylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2020to 11 Mar 2025
- Phase
- Phase 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with a histology or cytology proven solid advanced cancer, which failed or is intolerant of standard therapies known to offer survival benefit unless standard therapies include PD1 or PD-L1 antibodies
- Lead-in stage: patient with advanced cancers meeting the criteria above with or without prior treatment with PD1/PDL1 antibodies. Patients with prior treatment with PD1/PDL1 antibodies should be relapsed
- Efficacy stage cohort A: patients with advanced cancers not previously treated with PD1/PDL1 antibodies
- Efficacy stage cohort B: patients with advanced cancers which have relapsed or progressed with PD1/PDL1 antibodies
- Patient with a life expectancy of more than 3 months, in the opinion of the investigator
- Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 2
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- Patients < 18 years of age have to weigh > 40 kgs
- Patients must have measurable disease by RECIST 1.1 and iRECIST. Disease amenable to a biopsy is not mandatory
- Patient's acute toxic effects of previous anticancer therapy have resolved to =< grade 1 except for grade 2 peripheral neuropathy or any grade of alopecia
- Serum creatinine =< 1.5 times institutional upper limit of normal (ULN) or calculated creatinine clearance > 40 mL/min
- Serum albumin >= 2.5 g/dL
- Total bilirubin =< 1.5 x ULN (for patients with known Gilbert syndrome < 3 x ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x institutional ULN (patients with hepatic metastases must have AST/ALT =< 5 x ULN)
- Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
- Hemoglobin >= 8 g/dL and no red blood cell transfusions during the prior 7 days
- Platelet count >= 75 x 10^9/L
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 14 days prior to the initiation of treatment and/or postmenopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must agree and commit to the use of 2 highly effective methods of birth control throughout the duration of the study until at least 4 months following the last dose of study drug. Acceptable methods are defined as those that result, alone or in combination, in a low failure rate (ie, less than 1% per year) when used consistently and correctly, such as surgical sterilization, an intrauterine device, or hormonal contraception in combination with a barrier method. It is currently unknown whether BXCL701 or pembrolizumab may reduce the effectiveness of systemically acting hormonal contraceptives; therefore, women using systemically acting hormonal contraceptives should add a barrier method. In certain countries (if permitted by law), WOCBP may agree to abide by heterosexual sexual abstinence during the time of participation in this study
- Male patients and their female partners of childbearing potential must agree and commit to use a barrier contraception (eg, condom with spermicidal foam/gel/film/cream/suppository) throughout the duration of the study until at least 60 days following the last dose of study drug, in addition to their female partners using either an intrauterine device or hormonal contraception and continuing until at least 4 months days following the last dose of study drug. This criterion may be waived for male patients who have had a vasectomy > 6 months before signing the informed consent form (ICF)
- Patient has signed informed consent prior to initiation of any study-specific procedures or treatment
- Patient is able to adhere to the study visit schedule and other protocol requirements
Who cannot join
- Patient cannot swallow oral medication
- Patient is on gliptins
- Patient has active central nervous system (CNS) metastases not controlled by prior surgery or radiotherapy (patient must be off steroids). Patients with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by brain magnetic resonance imaging/computed tomography (MRI/CT)
- Patient has received external-beam radiation or another systemic anticancer therapy within 14 days or 5 half-lives, whichever is shorter, prior to study treatment
- Patient has received treatment with an investigational systemic anticancer agent within 14 days prior to study drug administration
- Patient has an additional active malignancy that may confound the assessment of the study endpoints. Patients with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer and carcinoma in situ (including transitional cell carcinoma, anal carcinoma, and melanoma in situ). Patients with simultaneous cancers, which are not active and do not require treatment may be eligible contingent on discussion with the principle investigator (PI) and supporter
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- Patient has clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina or stroke within 6 months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication)
- Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at a prednisone equivalent dose of > 10 mg daily for at least 1 week or other form of immunosuppressive therapy within 7 days prior to cycle 1 day 1 (C1D1)
- Patient has uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements
- Patient has known positive status for human immunodeficiency virus active or chronic hepatitis B or hepatitis C. Patients with history of hepatitis B or C and undetectable viral load are eligible. Screening is not required
- Has a clinically significant upper gastrointestinal obstruction, abnormal physiological function or malabsorption syndrome that may affect the absorption of the study medication
- Patient has any medical condition which, in the opinion of the investigator, places the patient at an unacceptably high risk for toxicity
- Patient is pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Basket Study of BXCL701, a Small Molecule Inhibitor of Dipeptidyl Peptidases (DPP), Administered in Combination With Pembrolizumab in Patients With Advanced Solid Cancers
This phase II trial studies the side effects of talabostat and pembrolizumab and to see how well they work for the treatment of solid cancers that have spread to other places in the body (advanced). Talabostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving talabostat and pembrolizumab may help control the disease.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate response rate per Response Evaluation Criteria in Solid Tumors (RECIST) and immune (i)RECIST in patients treated in cohort A and in patients treated in cohort B.
II. To evaluate dose-limiting toxicities (DLT) in the first 6 patients enrolled to the study.
SECONDARY OBJECTIVES:
- To evaluate progression-free survival (PFS). II. To evaluate duration of response (DOR). III. To evaluate overall survival (OS). IV. To evaluate overall safety and tolerability.
EXPLORATORY OBJECTIVES:
- To evaluate the quantitative and qualitative effects of talabostat (BXCL701) in combination with pembrolizumab on relevant immune effector cytokines in blood.
II. To evaluate the quantitative and qualitative effects of BXCL701 in combination with pembrolizumab on various immunological effector cells, including neutrophils, myeloid derived suppressor cells (MDSCs), dendritic cells, cancer associated fibroblast (CAF), T-cells and macrophage density in pre-dose tumor biopsies and when feasible in post-dose tumor tissues.
III. To explore the predictive value of baseline programmed death ligand 1 (PD-L1) tumor expression and tumor mutation burden (TMB) with clinical outcomes.
IV. To evaluate changes in serially collected blood circulating tumor deoxyribonucleic acid (DNA) (ctDNA) to assess for tumor response and clonal evolution.
- To evaluate pre- and post-treatment PD-L1 positron emission tomography (PET)/computed tomography (CT) as a predictive tool for therapeutic efficacy.
OUTLINE:
Patients receive talabostat orally (PO) twice daily (BID) on days 1-14 and pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
- Being tested
- Pembrolizumab, Talabostat Mesylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabBiological
Also called Keytruda, Lambrolizumab, MK-3475, SCH 900475
Given IV
Talabostat MesylateDrug
Also called Val-boro-Pro
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (talabostat, pembrolizumab) | Experimental | Patients receive talabostat PO BID on days 1-14 and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Biological: Pembrolizumab; Drug: Talabostat Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate Per RECIST v1.1
Disease control rate was defined as the percentage of patients who had complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1.
Measured: At baseline and at the end of Cycle 3 (approximately 9 weeks after the first study treatment dose), and then approximately every 9 weeks thereafter until development of progressive disease, up to 3 years
Immune-related Disease Control Rate Per iRECIST
Immune-related disease control rate was defined as the percentage of patients who had immune-related complete response (iCR), immune-related partial response (iPR), or immune-related stable disease (iSD) according to iRECIST.
Measured: At baseline and at the end of Cycle 3 (approximately 9 weeks after the first study treatment dose), and then approximately every 9 weeks thereafter until development of progressive disease, up to 3 years
Dose-limiting Toxicities (DLTs)
A DLT was defined as any of the following AEs occurring during Cycle 1, regardless of investigator attribution to study treatment:
- Any Grade 4 laboratory abnormality, regardless of duration.
- Any Grade 3 laboratory abnormalities if associated with clinical symptoms regardless of duration
- Any Grade ≥3 non-hematologic AE, with the exceptions of Grade ≥3 nausea, vomiting, diarrhea, constipation, and fatigue, that resolves to Grade ≤1 within 72 hours with optimal medical management and/or supportive measures.
- Grade ≥3 thrombocytopenia with Grade >1 bleeding or requirement for platelet transfusion.
- Grade ≥3 febrile neutropenia.
- Grade ≥3 fever.
- Grade ≥3 skin rash.
- AST or ALT >3 × upper limit of normal [ULN] with concomitant total bilirubin >2 × ULN.
- Any toxicity resulting in ≥30% held/skipped doses of BXCL701 during Cycle 1.
- Delay of Cycle 2 by ≥14 days due to toxicity.
- Any other significant toxicity considered by the investigatoro be dose-limiting.
Measured: DLT was assessed during Cycle 1 (21-day cycle)
Secondary outcomes (4)
Progression-free Survival (PFS) by RECIST v1.1
PFS was defined as the time from administration of the first dose to the first documented disease progression by RECIST v1.1 or death due to any cause, whichever occurs first. Patients who were alive and had not experienced disease progression at the time of data cutoff were censored.
Measured: At baseline and at the end of Cycle 3 (approximately 9 weeks after the first study treatment dose), and then approximately every 9 weeks thereafter until development of progressive disease, up to 3 years
Progression-free Survival (PFS) by iRECIST
PFS was defined as the time from administration of the first dose to the first documented disease progression by iRECIST v1.1 or death due to any cause, whichever occurs first. Patients who were alive and had not experienced disease progression at the time of data cutoff were censored.
Measured: At baseline and at the end of Cycle 3 (approximately 9 weeks after the first study treatment dose), and then approximately every 9 weeks thereafter until development of progressive disease, up to 3 years
Overall Survival (OS)
Overall survival was measured from the first date of administration of the study drug to the date of death due to any cause. Patients who were alive at the last follow-up examination were censored.
Measured: From the first date of administration of the study drug to the date of data cut-off (January 7, 2024)
Treatment-related Adverse Event (TRAE)
All safety data from all patients, who received at least one dose of study drug were included in safety analysis. Each AE (as defined by NCI CTCAE v5) was counted only once for a given subject. In the event a patient experienced repeated episodes of the same AE, then the event with the highest severity and/or strongest causal relationship to study treatment was used for purposes of tabulations.
Measured: Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start19 Mar 2020
- Primary completion11 Mar 2025
- Study completion11 Mar 2025
Why it stopped: There is no PR/CR observed in the first stage, so study stopped without proceeding to the stage 2 of efficacy stage.
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 Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Aung Naing, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171219
- Sponsor's protocol ID
- 2019-0748
- Other IDs
- NCI-2019-07569, 2019-0748
- Status last verified
- May 2025
- First submitted
- 18 Nov 2019
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Basket Study of BXCL701, a Small Molecule Inhibitor of Dipeptidyl Peptidases (DPP), Administered in Combination With Pembrolizumab in Patients With Advanced Solid Cancers
- ClinicalTrials.gov ID
- NCT04171219
- Acronym / sponsor ID
- 2019-0748
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There is no PR/CR observed in the first stage, so study stopped without proceeding to the stage 2 of efficacy stage.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Mar 2020 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Posted 16 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies the side effects of talabostat and pembrolizumab and to see how well they work for the treatment of solid cancers that have spread to other places in the body (advanced). Talabostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving talabostat and pembrolizumab may help control the disease.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate response rate per Response Evaluation Criteria in Solid Tumors (RECIST) and immune (i)RECIST in patients treated in cohort A and in patients treated in cohort B.
II. To evaluate dose-limiting toxicities (DLT) in the first 6 patients enrolled to the study.
SECONDARY OBJECTIVES:
- To evaluate progression-free survival (PFS). II. To evaluate duration of response (DOR). III. To evaluate overall survival (OS). IV. To evaluate overall safety and tolerability.
EXPLORATORY OBJECTIVES:
- To evaluate the quantitative and qualitative effects of talabostat (BXCL701) in combination with pembrolizumab on relevant immune effector cytokines in blood.
II. To evaluate the quantitative and qualitative effects of BXCL701 in combination with pembrolizumab on various immunological effector cells, including neutrophils, myeloid derived suppressor cells (MDSCs), dendritic cells, cancer associated fibroblast (CAF), T-cells and macrophage density in pre-dose tumor biopsies and when feasible in post-dose tumor tissues.
III. To explore the predictive value of baseline programmed death ligand 1 (PD-L1) tumor expression and tumor mutation burden (TMB) with clinical outcomes.
IV. To evaluate changes in serially collected blood circulating tumor deoxyribonucleic acid (DNA) (ctDNA) to assess for tumor response and clonal evolution.
- To evaluate pre- and post-treatment PD-L1 positron emission tomography (PET)/computed tomography (CT) as a predictive tool for therapeutic efficacy.
OUTLINE:
Patients receive talabostat orally (PO) twice daily (BID) on days 1-14 and pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (talabostat, pembrolizumab) | Experimental | Biological: Pembrolizumab, Drug: Talabostat MesylatePatients receive talabostat PO BID on days 1-14 and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Patient with a histology or cytology proven solid advanced cancer, which failed or is intolerant of standard therapies known to offer survival benefit unless standard therapies include PD1 or PD-L1 antibodies
- Patient with a life expectancy of more than 3 months, in the opinion of the investigator
- Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 2
- Patients < 18 years of age have to weigh > 40 kgs
- Patients must have measurable disease by RECIST 1.1 and iRECIST. Disease amenable to a biopsy is not mandatory
Key exclusion criteria (13 listed)
- Patient cannot swallow oral medication
- Patient is on gliptins
- Patient has active central nervous system (CNS) metastases not controlled by prior surgery or radiotherapy (patient must be off steroids). Patients with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by brain magnetic resonance imaging/computed tomography (MRI/CT)
- Patient has received external-beam radiation or another systemic anticancer therapy within 14 days or 5 half-lives, whichever is shorter, prior to study treatment
- Patient has received treatment with an investigational systemic anticancer agent within 14 days prior to study drug administration
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 |
|---|---|---|
| PembrolizumabAlso: Keytruda, Lambrolizumab, MK-3475, SCH 900475Given IV | Biological | Treatment (talabostat, pembrolizumab) |
| Talabostat MesylateAlso: Val-boro-ProGiven PO | Drug | Treatment (talabostat, pembrolizumab) |
Primary outcome
Disease Control Rate Per RECIST v1.1
Time frame: At baseline and at the end of Cycle 3 (approximately 9 weeks after the first study treatment dose), and then approximately every 9 weeks thereafter until development of progressive disease, up to 3 years
Disease control rate was defined as the percentage of patients who had complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1.
Immune-related Disease Control Rate Per iRECIST
Time frame: At baseline and at the end of Cycle 3 (approximately 9 weeks after the first study treatment dose), and then approximately every 9 weeks thereafter until development of progressive disease, up to 3 years
Immune-related disease control rate was defined as the percentage of patients who had immune-related complete response (iCR), immune-related partial response (iPR), or immune-related stable disease (iSD) according to iRECIST.
Dose-limiting Toxicities (DLTs)
Time frame: DLT was assessed during Cycle 1 (21-day cycle)
A DLT was defined as any of the following AEs occurring during Cycle 1, regardless of investigator attribution to study treatment: * Any Grade 4 laboratory abnormality, regardless of duration. * Any Grade 3 laboratory abnormalities if associated with clinical symptoms regardless of duration * Any Grade ≥3 non-hematologic AE, with the exceptions of Grade ≥3 nausea, vomiting, diarrhea, constipation, and fatigue, that resolves to Grade ≤1 within 72 hours with optimal medical management and/or supportive measures. * Grade ≥3 thrombocytopenia with Grade >1 bleeding or requirement for platelet transfusion. * Grade ≥3 febrile neutropenia. * Grade ≥3 fever. * Grade ≥3 skin rash. * AST or ALT >3 × upper limit of normal [ULN] with concomitant total bilirubin >2 × ULN. * Any toxicity resulting in ≥30% held/skipped doses of BXCL701 during Cycle 1. * Delay of Cycle 2 by ≥14 days due to toxicity. * Any other significant toxicity considered by the investigatoro be dose-limiting.
4 secondary outcomes
Progression-free Survival (PFS) by RECIST v1.1
Time frame: At baseline and at the end of Cycle 3 (approximately 9 weeks after the first study treatment dose), and then approximately every 9 weeks thereafter until development of progressive disease, up to 3 years
Progression-free Survival (PFS) by iRECIST
Time frame: At baseline and at the end of Cycle 3 (approximately 9 weeks after the first study treatment dose), and then approximately every 9 weeks thereafter until development of progressive disease, up to 3 years
Overall Survival (OS)
Time frame: From the first date of administration of the study drug to the date of data cut-off (January 7, 2024)
Treatment-related Adverse Event (TRAE)
Time frame: Patients were monitored for AE from the first day of administration of study medication through 30 days following the last dose of BXCL701 and or pembrolizumab, an average of 3 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Aung Naing, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab and Talabostat Mesylate in people with Advanced Malignant Solid Neoplasm and Recurrent Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site 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 20 inclusion and 13 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 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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 16 May 2025). 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?
Disease Control Rate Per RECIST v1.1 (time frame: At baseline and at the end of Cycle 3 (approximately 9 weeks after the first study treatment dose), and then approximately every 9 weeks thereafter until development of progressive disease, up to 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2025.