Your session is about to expire
← Back to Search
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
Study 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
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 moreTrial 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
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.
4 Previous Clinical Trials
361 Total Patients Enrolled
Adam Y-Beltrán, M.DStudy DirectorJounce Therapeutics, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have brain metastases or other conditions affecting your brain or spinal cord that are not well controlled with surgery or radiation.You've received treatment with JTX-8064, LILRB2, or ILT4-directed therapy before.You have stage 3 cancer, specifically platinum-resistant ovarian cancer, and have not received certain types of treatment before.You have advanced triple-negative breast cancer that has worsened after receiving a previous treatment called anti-PD-(L)1 therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (BTC)
- Group 2: Stage 2, Dose Escalation: JTX-8064 in combination with pimivalimab
- Group 3: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (TNBC)
- Group 4: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (NSCLC)
- Group 5: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (cSCC)
- Group 6: Stage 3 Expansion: JTX-8064 monotherapy (Ovarian)
- Group 7: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (ccRCC)
- Group 8: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (Ovarian)
- Group 9: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (UPS & LPS)
- Group 10: Stage 1, Dose Escalation: JTX-8064 monotherapy dose escalation
- Group 11: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (HNSCC)
- Group 12: Stage 4, Expansion: JTX-8064 in combination with pimivalimab (PD-(L)1i-experienced HNSCC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there a plethora of institutions conducting this research in North America?
"This clinical trial is running in 46 different sites, with 3 major hubs being Miami, Gilbert and Chicago. Participants are encouraged to select the nearest location to them as a way of managing travel requirements."
Answered by AI
Is this a pioneering research project?
"Jounce Therapeutics, Inc. initiated the first clinical trial of JTX-8064 in 2018 and it was successfully completed with 18 participants. Following this successful Phase 1 drug approval, 3 active trials have since been launched across 43 cities and 15 countries worldwide."
Answered by AI
Have there been any previous experiments conducted with JTX-8064?
"Initially examined in 2018 at South Texas Accelerated Research Therapeutics (START), JTX-8064 has yet to have a finished trial. However, currently 3 studies are ongoing with multiple sites situated close to Miami, Florida."
Answered by AI
Is this trial still accepting participants?
"clinicaltrials.gov states that this clinical study is actively seeking candidates, with the initial posting of 1/12/2021 and latest update on 10/10/2022."
Answered by AI
How many subjects are enrolled in this clinical investigation?
"Indeed, clinicaltrials.gov records that this experiment is currently recruiting participants - it was first released on the 12th of January 2021 and last modified on October 10th 2022. It requires 281 subjects to be enrolled at 46 sites."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger