CancerPhase 1/2NCT04669899
Study of JTX-8064, as Monotherapy and in Combination With a PD-1 Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumors
A Phase 1/2 study testing JTX-8064 and pimivalimab in people with Cancer, run by Jounce Therapeutics, Inc. at 45 sites in United States.
Trial summary
JTX-8064-101 is a Phase 1/2, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose (RP2D) of JTX-8064 alone and in combination with a PD-1 inhibitor (PD-1i). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- JTX-8064 and pimivalimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 45 sitesUnited States
- Study dates
- 12 Jan 2021to 28 Nov 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Able and willing to participate and comply with all study requirements and provide signed and dated informed consent prior to initiation of any study procedures;
- Histologically or cytologically confirmed advanced/metastatic extracranial solid tumor malignancy:
- Stages 1 and 2: Subjects must have received, have been intolerant to, have been ineligible for, or have declined all treatment known to confer clinical benefit with the exception of subjects enrolled in combination cohorts with a PD-1i, where a PD-1i is approved by the local regulatory agencies;
- Stage 3: This stage may enroll subjects with 3L/4L PD-(L)1-naïve, platinum-resistant ovarian cancer;
- Stage 4: This stage may enroll subjects with the following cancers:
- 2L/3L ccRCC. Subjects must have progressed on or after treatment with an anti-PD-(L)1 agent in their most recent prior line of therapy;
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- 2L-4L TNBC. Subjects must have progressed on or after treatment with a prior anti-PD-(L)1 therapy;
- 1L, PD-(L)1-naïve, PD-L1+; combined positive score (CPS) ≥1% HNSCC;
- 2L/3L platinum-experienced HNSCC. Subjects must have progressed on or after treatment with an anti-PD-(L)1-agent in their most recent prior line of therapy;
- 3L/4L, PD-(L)1-naïve, platinum-resistant ovarian cancer;
- 2L/3L NSCLC. Subjects must have progressed on or after treatment with platinum-based chemotherapy and an anti-PD-(L)1-containing therapy. The anti-PD-(L)1 agent must have been a part of the most recent prior line of therapy. Subjects with EGFR mutations and ALK rearrangements will be excluded. Subjects with other targetable genomic aberrations for which FDA approved therapies exist must have received appropriate FDA-approved targeted therapy;
- 2L/3L cSCC. Subjects must have progressed on or after treatment with an anti-PD-(L)1 agent in their most recent prior line of therapy;
- 2L-4L PD-(L)1-naïve undifferentiated pleomorphic sarcoma (UPS) and liposarcoma (LPS);
- 2L/3L biliary tract cancer (BTC), including intra- and extra-hepatic biliary duct cancer and cancer of the gallbladder. Subjects must have progressed on or after gemcitabine/cisplatin (Gem/Cis) in the metastatic setting and must have PD-(L)1 inhibitor resistance. Subjects with FGFR and IDH1 mutations must have progressed on or after targeted therapies for these mutations;
- Measurable disease, according to the RECIST version 1.1, that has objectively progressed since (or on) previous treatment as assessed by the Investigator;
- ≥18 years of age;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- Predicted life expectancy of ≥3 months;
- Have specified laboratory values (obtained ≤28 days prior to planned Cycle 1, Day 1 [C1D1]) in accordance with the study protocol;
- For women of childbearing potential (WOCBP): negative serum pregnancy test during the Screening period and a negative urine pregnancy test up to 24 hours in advance of C1D1;
- WOCBP and males whose partners are WOCBP must agree to use a highly effective method of birth control throughout their participation and for 5 months following the last study drug administration.
Who cannot join
- Concurrent anticancer treatment, either FDA approved or investigational, for the cancer being evaluated in this study or for prior malignancies. A past history of other malignancies is allowed as long as the subject is not receiving treatment other than hormonal therapy and, in the judgment of the Investigator, is unlikely to have a recurrence. Of note, concurrent malignancies that do not require treatment and are clinically stable are allowed;
- Prior infusion of JTX-8064, LILRB2, or ILT4-directed therapy;
- The therapies listed below within the specified timeframe or ongoing toxicity attributed to prior therapy that was >Grade 1 according to the NCI CTCAE, version 5.0. Exceptions: >Grade 1 toxicities that, in the opinion of the Investigator, should not exclude the subject (e.g., alopecia, Grade 2 neuropathy, hypo- or hyperthyroidism, or other endocrinopathies that are well controlled with hormone replacement) and are approved by the Medical Monitor:
- Major surgery (excluding minor procedures, for example, placement of vascular access, gastrointestinal/biliary stent, biopsy) <4 weeks prior to planned C1D1;
- Immunotherapy or biologic therapy <28 days prior to planned C1D1 or 5 half-lives, whichever is shorter;
- Chemotherapy <21 days prior to planned C1D1, or <42 days for mitomycin or nitrosoureas or 5 half-lives, whichever is shorter;
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- Targeted small molecule therapy <14 days or 5 half-lives, whichever is shorter, prior to planned C1D1;
- Hormonal or other adjunctive therapy for cancers other than the cancer under evaluation in this study that started <14 days prior to planned C1D1 are not permitted; however, antiestrogen therapy, bisphosphonates, somatostatin analogues, leuprolide, and denosumab are permitted if started ≥14 days prior to C1D1. Other hormonal treatments and/or treatment for stable cancers (other than the cancer being treated on-study) may also be permitted 1) if these therapies would not be expected to have any positive or negative effect on the cancer being treated and 2) if discussed with and approved by the Medical Monitor;
- Radiation therapy <21 days prior to planned C1D1. Exception: Limited (e.g., pain palliation) radiation therapy is allowed prior to and during study drug administration as long as there are no acute toxicities, any AE due to prior radiation therapy has recovered to <Grade 2, and the radiation is not administered to a target lesion;
- Any prior organ transplantation, including allogeneic or autologous stem cell transplantation;
- History of intolerance, hypersensitivity, or treatment discontinuation due to Grade 3 or greater irAEs (related to prior immunotherapy);
- Diagnosis of immunodeficiency, either primary or acquired, or treatment with immunosuppressive levels of systemic corticosteroids (equivalent to ≥10 mg prednisone per day) or any other form of immunosuppressive therapy within 7 days prior to planned C1D1. Exception: Inhaled, intra-articular, topical, or systemic corticosteroids (systemic only at doses intended for adrenal replacement) and doses of immunosuppressive agents used prophylactically for contrast allergies are permitted in the absence of active autoimmune disease;
- Known severe intolerance or life-threatening hypersensitivity reactions to humanized mAbs or IV immunoglobulin preparations; any history of anaphylaxis; known allergy to any of the study medications, their analogues, or excipients (sodium acetate, sucrose, sodium chloride and polysorbate 80) in the various formulations of any agent;
- Symptomatic or uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation (brain metastases that are stable and asymptomatic after prior treatment will be allowed);
- Active and clinically relevant bacterial, fungal, or viral infection, including known hepatitis A, B, or C, or HIV (testing not required);
- Women who are pregnant or breastfeeding or who plan to become pregnant/breastfeed while on study; men who plan to father children during the study;
- History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, or severe (≥Grade 3) radiation pneumonitis (excluding localized radiation pneumonitis);
- History in the last 3 months of acute diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction, unless approved by Medical Monitor;
- Symptomatic cardiac or cerebrovascular disease that is unresponsive to surgical or medical management;
- Medical or social condition that, in the opinion of the Investigator, might place the subject at increased risk, adversely affect compliance, or confound safety or other clinical study data interpretation;
- Active disease requiring systemic immunosuppressive therapy;
- Live vaccines ≤30 days of C1D1;
- Deep vein thrombosis, pulmonary embolism (including asymptomatic pulmonary embolism identified on imaging), or other thromboembolic event within the 6 months preceding C1D1 for JTX-8064 monotherapy cohorts only.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
University of Michigan
Ann Arbor, Michigan, 48109
Augusta Oncology Associates - Wheeler Road
Augusta, Georgia, 30909
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Gabrail Cancer Center
Canton, Ohio, 44718
University of Chicago
Chicago, Illinois, 60637
UC Health, LLC
Cincinnati, Ohio, 45229
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Mary Crowley Cancer Research
Dallas, Texas, 75230
Cancer Care Center of Decatur
Decatur, Illinois, 62526
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
City of Hope
Duarte, California, 91010
University of Florida
Gainesville, Florida, 32610
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
START Midwest -Cancer & Hematology Center of Western Michigan
Grand Rapids, Michigan, 49546
Prisma Health
Greenville, South Carolina, 29605
Oncology Consultants, P.A.
Houston, Texas, 77024
MD Anderson
Houston, Texas, 77030
Carolina BioOncology
Huntersville, North Carolina, 28708
California Cancer Associates for Research & Excellence, Inc.
La Jolla, California, 92037
University of California, San Diego
La Jolla, California, 92093
University of Kentucky Chandler Medical Center (UKCMC)
Lexington, Kentucky, 40536
University of Arkansas Medical Sciences
Little Rock, Arkansas, 72205
Cedars Sinai
Los Angeles, California, 90048
Joe Arrington Cancer Research & Treatment Center
Lubbock, Texas, 79410
The Board of Regents of the University of Wisconsin
Madison, Wisconsin, 53792
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Regents of the University of Minnesota
Minneapolis, Minnesota, 55455
Yale University
New Haven, Connecticut, 06519
Weill Cornell
New York, New York, 10021
Mount Sinai
New York, New York, 10029
Montefiore Medical Center PRIME
New York, New York, 10461
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
UC Irvine Medical Center
Orange, California, 92868
Adventist Health System/Sunbelt, Inc.
Orlando, Florida, 32803
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Providence Portland Cancer Center
Portland, Oregon, 97213
University of California, Davis
Sacramento, California, 95817
START Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
Seattle Cancer Care Alliance
Seattle, Washington, 98331
Tampa General Hospital
Tampa, Florida, 33606
Arizona Clinical Research Center
Tucson, Arizona, 85258
Georgetown University
Washington D.C., District of Columbia, 20057
START Mountain Region
West Valley City, Utah, 84119
About this study
Official title: Phase 1/2 First-in-Human (FIH) Study of Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2) Inhibitor Monoclonal Antibody (mAb) JTX-8064, as Monotherapy and in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumor Malignancies
JTX-8064-101 is a Phase 1/2, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose (RP2D) of JTX-8064 alone and in combination with a PD-1 inhibitor (PD-1i).
Read the detailed description
JTX-8064 is a humanized mAb designed to block the interaction of LILRB2 with its known ligands, endogenous major histocompatibility complex class I (MHC I) molecules. This is a Phase 1/2, first in human, open label, multicenter, dose escalation and dose expansion clinical trial to determine the safety, tolerability, maximum tolerated dose (MTD) and RP2D of JTX-8064 when administered as a single agent and in combination with a PD-1i in adult subjects with advanced refractory solid tumor malignancies. Additionally, the study will seek to evaluate the pharmacokinetics and immunogenicity of JTX-8064, and preliminary efficacy of JTX-8064 as a monotherapy and in combination with a PD-1i.
- Conditions
- Cancer
- Being tested
- JTX-8064, pimivalimab
- Keywords
- JTX-8064, LILRB2, ILT4, PD-1, JTX-4014, Immunotherapy, Immuno-oncology, Solid tumor Malignancies, Dose escalation, INNATE, Monotherapy, Combination Therapy, Antineoplastic Agents, Immunological
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JTX-8064Drug
Also called Anti-LILRB2, Anti-ILT4
Specified dose on specified days
pimivalimabDrug
Also called JTX-4014, Anti-PD-1
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Stage 1, Dose Escalation: JTX-8064 monotherapy dose escalation | Experimental | Dose Escalation, Stage 1: JTX-8064 Monotherapy. Cohorts will enroll subjects with histologically or cytologically confirmed advanced/metastatic extracranial solid tumor malignancies. Receives: Drug: JTX-8064 |
| Stage 2, Dose Escalation: JTX-8064 in combination with pimivalimab | Experimental | Dose Escalation, Stage 2: JTX-8064 in combination with pimivalimab. Cohorts will enroll subjects with histologically or cytologically confirmed advanced/metastatic extracranial solid tumor malignancies. Receives: Drug: JTX-8064; Drug: pimivalimab |
| Stage 3 Expansion: JTX-8064 monotherapy (Ovarian) | Experimental | Cohort will enroll subjects with advanced/metastatic PD-1/PD-L1 (PD-(L)1)-naïve, platinum-resistant ovarian cancer. Receives: Drug: JTX-8064 |
| Stage 4, Expansion: JTX-8064 in combination with pimivalimab (ccRCC) | Experimental | JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1i-experienced clear cell renal cell carcinoma (ccRCC). Receives: Drug: JTX-8064; Drug: pimivalimab |
| Stage 4, Expansion: JTX-8064 in combination with pimivalimab (TNBC) | Experimental | JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1i-experienced triple negative breast cancer (TNBC). Receives: Drug: JTX-8064; Drug: pimivalimab |
| Stage 4, Expansion: JTX-8064 in combination with pimivalimab (HNSCC) | Experimental | JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-naïve, PD-L1+ head and neck squamous cell carcinoma (HNSCC). Receives: Drug: JTX-8064; Drug: pimivalimab |
| Stage 4, Expansion: JTX-8064 in combination with pimivalimab (Ovarian) | Experimental | JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-naïve, platinum-resistant ovarian cancer. Receives: Drug: JTX-8064; Drug: pimivalimab |
| Stage 4, Expansion: JTX-8064 in combination with pimivalimab (NSCLC) | Experimental | JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-experienced non-small cell lung cancer (NSCLC). Receives: Drug: JTX-8064; Drug: pimivalimab |
| Stage 4, Expansion: JTX-8064 in combination with pimivalimab (cSCC) | Experimental | JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-experienced cutaneous squamous cell carcinoma (cSCC). Receives: Drug: JTX-8064; Drug: pimivalimab |
| Stage 4, Expansion: JTX-8064 in combination with pimivalimab (UPS & LPS) | Experimental | JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-naïve undifferentiated pleomorphic sarcoma (UPS) and liposarcoma (LPS). Receives: Drug: JTX-8064; Drug: pimivalimab |
| Stage 4, Expansion: JTX-8064 in combination with pimivalimab (PD-(L)1i-experienced HNSCC) | Experimental | JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with PD-(L)1i-experienced HNSCC. Receives: Drug: JTX-8064; Drug: pimivalimab |
| Stage 4, Expansion: JTX-8064 in combination with pimivalimab (BTC) | Experimental | JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with biliary tract cancer (BTC), including intra-and extra-hepatic biliary duct cancer and cancer of the gallbladder. All subjects must have progressed on or after gemcitabine/cisplatin (Gem/Cis) in the metastatic setting, must have PD-(L)1i resistance. Receives: Drug: JTX-8064; Drug: pimivalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of DLTs, treatment-emergent adverse events (TEAEs), serious TEAEs, and discontinuation due to adverse events (AEs) evaluated using National Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) version 5.0
Measured: up to 24 months
Determination of a RP2D for JTX-8064 monotherapy and in combination with a PD-1i
Measured: up to 24 months
Secondary outcomes (16)
Cmax (the maximum observed concentration) for JTX-8064 monotherapy and in combination with a PD-1i
Measured: Cycles 1 through 12 (each cycle is 21 days)
Tmax (time of maximum observed concentration) for JTX-8064 monotherapy and in combination with a PD-1i
Measured: Cycles 1 through 12 (each cycle is 21 days)
Cmin for JTX-8064 monotherapy and in combination with a PD-1i
Measured: Cycles 1 through 12 (each cycle is 21 days)
AUClast (area under the concentration-time curve from time 0 to the last measurable concentration) for JTX-8064 monotherapy and in combination with a PD-1i
Measured: Cycles 1 and 3 (each cycle is 21 days)
Cmax for PD-1i in combination with JTX-8064
Measured: Cycles 1 through 12 (each cycle is 21 days)
Tmax for PD-1i in combination with JTX-8064
Measured: Cycles 1 through 12 (each cycle is 21 days)
Cmin for PD-1i in combination with JTX-8064
Measured: Cycles 1 through 12 (each cycle is 21 days)
Incidence of anti-drug antibodies (ADAs) to JTX-8064 and, as appropriate, to PD-1i
Measured: Baseline through Cycle 12 (each cycle is 21 days)
Incidence of neutralizing antibodies (Nabs) to JTX-8064 and, as appropriate, to PD-1i
Measured: Baseline through Cycle 12 (each cycle is 21 days)
For Stages 1 and 2: Receptor occupancy for LILRB2 on monocytes in whole blood
Measured: Baseline through Cycle 6 (each cycle is 21 days)
For Stages 3 and 4: Preliminary efficacy endpoints: Objective response rate (ORR; the proportion of subjects who have had a partial response [PR] or complete response [CR]) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: up to 36 months
For Stages 3 and 4: Preliminary efficacy endpoints: Disease control rate (DCR; the proportion of subjects who have a PR, CR, or stable disease [SD]), as per RECIST version 1.1
Measured: up to 36 months
For Stages 3 and 4: Preliminary efficacy endpoints: Progression-free survival (PFS; the interval from start of treatment to the earlier of first documentation of disease progression or death from any cause)
Measured: up to 36 months
For Stages 3 and 4: Preliminary efficacy endpoints: Overall survival (OS; the interval from start of treatment to death of any cause)
Measured: up to 36 months
For Stages 3 and 4: Preliminary efficacy endpoints: Duration of response (DOR; the time from documentation of tumor progression or death due to any cause, whichever comes first)
Measured: up to 36 months
For Stages 3 and 4: Preliminary efficacy endpoints: Percentage of subjects with tumor reduction at any time
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start12 Jan 2021
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jounce Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stew Kroll, Study director, Jounce Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669899
- Sponsor's protocol ID
- JTX-8064-101
- Status last verified
- Apr 2024
- First submitted
- 4 Dec 2020
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 First-in-Human (FIH) Study of Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2) Inhibitor Monoclonal Antibody (mAb) JTX-8064, as Monotherapy and in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT04669899
- Acronym / sponsor ID
- JTX-8064-101
- Conditions
- Cancer
- Keywords
- JTX-8064, LILRB2, ILT4, PD-1, JTX-4014, Immunotherapy, Immuno-oncology, Solid tumor Malignancies
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Jounce Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
JTX-8064-101 is a Phase 1/2, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose (RP2D) of JTX-8064 alone and in combination with a PD-1 inhibitor (PD-1i).
Detailed description
JTX-8064 is a humanized mAb designed to block the interaction of LILRB2 with its known ligands, endogenous major histocompatibility complex class I (MHC I) molecules. This is a Phase 1/2, first in human, open label, multicenter, dose escalation and dose expansion clinical trial to determine the safety, tolerability, maximum tolerated dose (MTD) and RP2D of JTX-8064 when administered as a single agent and in combination with a PD-1i in adult subjects with advanced refractory solid tumor malignancies. Additionally, the study will seek to evaluate the pharmacokinetics and immunogenicity of JTX-8064, and preliminary efficacy of JTX-8064 as a monotherapy and in combination with a PD-1i.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Stage 1, Dose Escalation: JTX-8064 monotherapy dose escalation | Experimental | Drug: JTX-8064Dose Escalation, Stage 1: JTX-8064 Monotherapy. Cohorts will enroll subjects with histologically or cytologically confirmed advanced/metastatic extracranial solid tumor malignancies. |
| Stage 2, Dose Escalation: JTX-8064 in combination with pimivalimab | Experimental | Drug: JTX-8064, Drug: pimivalimabDose Escalation, Stage 2: JTX-8064 in combination with pimivalimab. Cohorts will enroll subjects with histologically or cytologically confirmed advanced/metastatic extracranial solid tumor malignancies. |
| Stage 3 Expansion: JTX-8064 monotherapy (Ovarian) | Experimental | Drug: JTX-8064Cohort will enroll subjects with advanced/metastatic PD-1/PD-L1 (PD-(L)1)-naïve, platinum-resistant ovarian cancer. |
| Stage 4, Expansion: JTX-8064 in combination with pimivalimab (ccRCC) | Experimental | Drug: JTX-8064, Drug: pimivalimabJTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1i-experienced clear cell renal cell carcinoma (ccRCC). |
| Stage 4, Expansion: JTX-8064 in combination with pimivalimab (TNBC) | Experimental | Drug: JTX-8064, Drug: pimivalimabJTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1i-experienced triple negative breast cancer (TNBC). |
| Stage 4, Expansion: JTX-8064 in combination with pimivalimab (HNSCC) | Experimental | Drug: JTX-8064, Drug: pimivalimabJTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-naïve, PD-L1+ head and neck squamous cell carcinoma (HNSCC). |
| Stage 4, Expansion: JTX-8064 in combination with pimivalimab (Ovarian) | Experimental | Drug: JTX-8064, Drug: pimivalimabJTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-naïve, platinum-resistant ovarian cancer. |
| Stage 4, Expansion: JTX-8064 in combination with pimivalimab (NSCLC) | Experimental | Drug: JTX-8064, Drug: pimivalimabJTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-experienced non-small cell lung cancer (NSCLC). |
| Stage 4, Expansion: JTX-8064 in combination with pimivalimab (cSCC) | Experimental | Drug: JTX-8064, Drug: pimivalimabJTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-experienced cutaneous squamous cell carcinoma (cSCC). |
| Stage 4, Expansion: JTX-8064 in combination with pimivalimab (UPS & LPS) | Experimental | Drug: JTX-8064, Drug: pimivalimabJTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-naïve undifferentiated pleomorphic sarcoma (UPS) and liposarcoma (LPS). |
| Stage 4, Expansion: JTX-8064 in combination with pimivalimab (PD-(L)1i-experienced HNSCC) | Experimental | Drug: JTX-8064, Drug: pimivalimabJTX-8064 in combination with pimivalimab. Cohort will enroll subjects with PD-(L)1i-experienced HNSCC. |
| Stage 4, Expansion: JTX-8064 in combination with pimivalimab (BTC) | Experimental | Drug: JTX-8064, Drug: pimivalimabJTX-8064 in combination with pimivalimab. Cohort will enroll subjects with biliary tract cancer (BTC), including intra-and extra-hepatic biliary duct cancer and cancer of the gallbladder. All subjects must have progressed on or after gemcitabine/cisplatin (Gem/Cis) in the metastatic setting, must have PD-(L)1i resistance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Able and willing to participate and comply with all study requirements and provide signed and dated informed consent prior to initiation of any study procedures;
- Histologically or cytologically confirmed advanced/metastatic extracranial solid tumor malignancy:
- Measurable disease, according to the RECIST version 1.1, that has objectively progressed since (or on) previous treatment as assessed by the Investigator;
- ≥18 years of age;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
Key exclusion criteria (23 listed)
- Concurrent anticancer treatment, either FDA approved or investigational, for the cancer being evaluated in this study or for prior malignancies. A past history of other malignancies is allowed as long as the subject is not receiving treatment other than hormonal therapy and, in the judgment of the Investigator, is unlikely to have a recurrence. Of note, concurrent malignancies that do not require treatment and are clinically stable are allowed;
- Prior infusion of JTX-8064, LILRB2, or ILT4-directed therapy;
- The therapies listed below within the specified timeframe or ongoing toxicity attributed to prior therapy that was >Grade 1 according to the NCI CTCAE, version 5.0. Exceptions: >Grade 1 toxicities that, in the opinion of the Investigator, should not exclude the subject (e.g., alopecia, Grade 2 neuropathy, hypo- or hyperthyroidism, or other endocrinopathies that are well controlled with hormone replacement) and are approved by the Medical Monitor:
- History of intolerance, hypersensitivity, or treatment discontinuation due to Grade 3 or greater irAEs (related to prior immunotherapy);
- Diagnosis of immunodeficiency, either primary or acquired, or treatment with immunosuppressive levels of systemic corticosteroids (equivalent to ≥10 mg prednisone per day) or any other form of immunosuppressive therapy within 7 days prior to planned C1D1. Exception: Inhaled, intra-articular, topical, or systemic corticosteroids (systemic only at doses intended for adrenal replacement) and doses of immunosuppressive agents used prophylactically for contrast allergies are permitted in the absence of active autoimmune disease;
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 |
|---|---|---|
| JTX-8064Also: Anti-LILRB2, Anti-ILT4Specified dose on specified days | Drug | Stage 1, Dose Escalation: JTX-8064 monotherapy dose escalation, Stage 2, Dose Escalation: JTX-8064 in combination with pimivalimab, Stage 3 Expansion: JTX-8064 monotherapy (Ovarian), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (BTC), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (HNSCC), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (NSCLC), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (Ovarian), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (PD-(L)1i-experienced HNSCC), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (TNBC), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (UPS & LPS), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (cSCC), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (ccRCC) |
| pimivalimabAlso: JTX-4014, Anti-PD-1Specified dose on specified days | Drug | Stage 2, Dose Escalation: JTX-8064 in combination with pimivalimab, Stage 4, Expansion: JTX-8064 in combination with pimivalimab (BTC), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (HNSCC), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (NSCLC), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (Ovarian), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (PD-(L)1i-experienced HNSCC), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (TNBC), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (UPS & LPS), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (cSCC), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (ccRCC) |
Primary outcome
Incidence and severity of DLTs, treatment-emergent adverse events (TEAEs), serious TEAEs, and discontinuation due to adverse events (AEs) evaluated using National Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: up to 24 months
Determination of a RP2D for JTX-8064 monotherapy and in combination with a PD-1i
Time frame: up to 24 months
16 secondary outcomes
Cmax (the maximum observed concentration) for JTX-8064 monotherapy and in combination with a PD-1i
Time frame: Cycles 1 through 12 (each cycle is 21 days)
Tmax (time of maximum observed concentration) for JTX-8064 monotherapy and in combination with a PD-1i
Time frame: Cycles 1 through 12 (each cycle is 21 days)
Cmin for JTX-8064 monotherapy and in combination with a PD-1i
Time frame: Cycles 1 through 12 (each cycle is 21 days)
AUClast (area under the concentration-time curve from time 0 to the last measurable concentration) for JTX-8064 monotherapy and in combination with a PD-1i
Time frame: Cycles 1 and 3 (each cycle is 21 days)
Cmax for PD-1i in combination with JTX-8064
Time frame: Cycles 1 through 12 (each cycle is 21 days)
Tmax for PD-1i in combination with JTX-8064
Time frame: Cycles 1 through 12 (each cycle is 21 days)
Cmin for PD-1i in combination with JTX-8064
Time frame: Cycles 1 through 12 (each cycle is 21 days)
Incidence of anti-drug antibodies (ADAs) to JTX-8064 and, as appropriate, to PD-1i
Time frame: Baseline through Cycle 12 (each cycle is 21 days)
Incidence of neutralizing antibodies (Nabs) to JTX-8064 and, as appropriate, to PD-1i
Time frame: Baseline through Cycle 12 (each cycle is 21 days)
For Stages 1 and 2: Receptor occupancy for LILRB2 on monocytes in whole blood
Time frame: Baseline through Cycle 6 (each cycle is 21 days)
For Stages 3 and 4: Preliminary efficacy endpoints: Objective response rate (ORR; the proportion of subjects who have had a partial response [PR] or complete response [CR]) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: up to 36 months
For Stages 3 and 4: Preliminary efficacy endpoints: Disease control rate (DCR; the proportion of subjects who have a PR, CR, or stable disease [SD]), as per RECIST version 1.1
Time frame: up to 36 months
For Stages 3 and 4: Preliminary efficacy endpoints: Progression-free survival (PFS; the interval from start of treatment to the earlier of first documentation of disease progression or death from any cause)
Time frame: up to 36 months
For Stages 3 and 4: Preliminary efficacy endpoints: Overall survival (OS; the interval from start of treatment to death of any cause)
Time frame: up to 36 months
For Stages 3 and 4: Preliminary efficacy endpoints: Duration of response (DOR; the time from documentation of tumor progression or death due to any cause, whichever comes first)
Time frame: up to 36 months
For Stages 3 and 4: Preliminary efficacy endpoints: Percentage of subjects with tumor reduction at any time
Time frame: up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
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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.
Stew Kroll study director
Jounce Therapeutics, Inc.
45 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 JTX-8064 and pimivalimab in people with Cancer, run by Jounce Therapeutics, Inc. at 45 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 21 inclusion and 23 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: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and severity of DLTs, treatment-emergent adverse events (TEAEs), serious TEAEs, and discontinuation due to adverse events (AEs) evaluated using National Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) version 5.0 (time frame: up to 24 months). The study lists 2 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 9 Apr 2024.