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Monoclonal Antibodies

JTX-8064 + PD-1 Inhibitor for Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Jounce Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Summary

This trial is testing a new drug, JTX-8064, to see if it is safe and effective when used alone or with a another drug, a PD-1 inhibitor.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include typical reactions related to immune therapies such as fatigue, skin reactions, inflammation in various organs which can cause symptoms like cough or diarrhea depending on the organ affected; infusion-related reactions; potential changes in blood tests indicating liver or kidney function issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determination of a RP2D for JTX-8064 monotherapy and in combination with a PD-1i
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
Secondary outcome measures
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
Cmax (the maximum observed concentration) for JTX-8064 monotherapy and in combination with a PD-1i
Cmax for PD-1i in combination with JTX-8064
+13 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pimivalimab
2021
Completed Phase 2
~190
JTX-8064
2021
Completed Phase 2
~190

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Immunotherapy, including treatments like JTX-8064, works by modulating the immune system to recognize and attack cancer cells more effectively. These therapies often target immune checkpoints, such as PD-1/PD-L1, which cancer cells exploit to evade immune detection. By inhibiting these checkpoints, immunotherapy can enhance the body's natural immune response against tumors. This approach is crucial for cancer patients as it offers a targeted treatment option that can potentially lead to longer-lasting remissions and fewer side effects compared to traditional therapies like chemotherapy and radiation.

Find a Location

Who is running the clinical trial?

Jounce Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
394 Total Patients Enrolled
Stew KrollStudy DirectorJounce Therapeutics, Inc.
5 Previous Clinical Trials
365 Total Patients Enrolled
Adam Y-Beltrán, M.DStudy DirectorJounce Therapeutics, Inc.

Media Library

JTX-8064 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04669899 — Phase 1 & 2
Cancer Research Study Groups: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (BTC), Stage 2, Dose Escalation: JTX-8064 in combination with pimivalimab, Stage 4, Expansion: JTX-8064 in combination with pimivalimab (TNBC), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (NSCLC), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (cSCC), Stage 3 Expansion: JTX-8064 monotherapy (Ovarian), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (ccRCC), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (Ovarian), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (UPS & LPS), Stage 1, Dose Escalation: JTX-8064 monotherapy dose escalation, Stage 4, Expansion: JTX-8064 in combination with pimivalimab (HNSCC), Stage 4, Expansion: JTX-8064 in combination with pimivalimab (PD-(L)1i-experienced HNSCC)
Cancer Clinical Trial 2023: JTX-8064 Highlights & Side Effects. Trial Name: NCT04669899 — Phase 1 & 2
JTX-8064 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04669899 — Phase 1 & 2
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