JTX-8064 + PD-1 Inhibitor for Cancer

Recruiting in Palo Alto (17 mi)

+47 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Jounce Therapeutics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests JTX-8064, a protein that helps the immune system attack cancer, in adults with advanced cancers that don't respond to standard treatments. It works by stopping cancer cells from hiding from the immune system.

Eligibility Criteria

Adults with advanced solid tumors that have not responded to standard treatments, including those who've progressed after chemotherapy and immunotherapy. Specific conditions like biliary tract cancer, kidney cancer, head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), cutaneous squamous cell carcinoma (cSCC), uterine sarcomas, and triple-negative breast cancer are included at different stages. Participants must be over 18 years old with a life expectancy of more than 3 months and meet certain health criteria.

Inclusion Criteria

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: Subject 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

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Exclusion Criteria

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

The therapies listed below within the specified timeframe: 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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Participant Groups

The trial is testing JTX-8064 alone or combined with a PD-1 inhibitor in patients whose cancers haven't improved with other treatments. It's an early-phase study to find the safest dose for future research. Patients will receive these drugs through infusions and their effects will be closely monitored.

12Treatment groups

Experimental Treatment

Group I: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (ccRCC)Experimental Treatment2 Interventions

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1i-experienced clear cell renal cell carcinoma (ccRCC).

Group II: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (cSCC)Experimental Treatment2 Interventions

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-experienced cutaneous squamous cell carcinoma (cSCC).

Group III: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (UPS & LPS)Experimental Treatment2 Interventions

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-naïve undifferentiated pleomorphic sarcoma (UPS) and liposarcoma (LPS).

Group IV: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (TNBC)Experimental Treatment2 Interventions

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1i-experienced triple negative breast cancer (TNBC).

Group V: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (PD-(L)1i-experienced HNSCC)Experimental Treatment2 Interventions

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with PD-(L)1i-experienced HNSCC.

Group VI: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (Ovarian)Experimental Treatment2 Interventions

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-naïve, platinum-resistant ovarian cancer.

Group VII: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (NSCLC)Experimental Treatment2 Interventions

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-experienced non-small cell lung cancer (NSCLC).

Group VIII: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (HNSCC)Experimental Treatment2 Interventions

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).

Group IX: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (BTC)Experimental Treatment2 Interventions

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.

Group X: Stage 3 Expansion: JTX-8064 monotherapy (Ovarian)Experimental Treatment1 Intervention

Cohort will enroll subjects with advanced/metastatic PD-1/PD-L1 (PD-(L)1)-naïve, platinum-resistant ovarian cancer.

Group XI: Stage 2, Dose Escalation: JTX-8064 in combination with pimivalimabExperimental Treatment2 Interventions

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.

Group XII: Stage 1, Dose Escalation: JTX-8064 monotherapy dose escalationExperimental Treatment1 Intervention

Dose Escalation, Stage 1: JTX-8064 Monotherapy. Cohorts will enroll subjects with histologically or cytologically confirmed advanced/metastatic extracranial solid tumor malignancies.