All > Miami > Milwaukee

JTX-8064 for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
CancerJTX-8064 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
SRK-181
1
a PD-1 inhibitor
1
VT3989

Study Objectives

2 Primary · 16 Secondary · Reporting Duration: up to 36 months

Day 21
Incidence of ADAs to JTX-8064 and, as appropriate, to PD-1i
Incidence of neutralizing antibodies (Nabs) to JTX-8064 and, as appropriate, to PD-1i
Day 21
For Stages 1 and 2: Receptor occupancy for LILRB2 on monocytes in whole blood
Day 21
AUClast (area under the concentration-time curve from time 0 to the last measurable concentration) for JTX-8064 when administered as monotherapy or in combination with a PD-1i
Day 21
Cmax (the maximum observed concentration) for JTX-8064 when administered as monotherapy or in combination with a PD-1i
Cmin for JTX-8064 when administered as monotherapy or in combination with a PD-1i
Tmax (time of maximum observed concentration) for JTX-8064 when administered as monotherapy or in combination with a PD-1i
Day 21
Cmax for PD-1i in combination with JTX-8064
Cmin for PD-1i in combination with JTX-8064
Tmax for PD-1i in combination with JTX-8064
up to 12 months
Determination of a RP2D for JTX-8064 monotherapy and in combination with JTX-4014 or pembrolizumab
up to 18 months
Incidence and severity of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), serious TEAEs, and discontinuation due to adverse events (AEs).
up to 36 months
For Stages 3 and 4: Preliminary efficacy endpoints: DCR (the proportion of subjects who have a PR, CR or stable disease SD), as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
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)
For Stages 3 and 4: Preliminary efficacy endpoints: 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
For Stages 3 and 4: Preliminary efficacy endpoints: Overall survival (OS) (the interval from start of treatment to death of any cause)
For Stages 3 and 4: Preliminary efficacy endpoints: Percentage of subjects with tumor reduction at any time
For Stages 3 and 4: Preliminary efficacy endpoints: Progression-free survival (PFS) (interval from start of treatment to the earlier of first documentation of disease progression or death from any cause)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
SRK-181
1
a PD-1 inhibitor
1
VT3989

Trial Design

12 Treatment Groups

Stage 4, Expansion: JTX-8064 in combination with pimivalimab (ccRCC)
1 of 12
Stage 4, Expansion: JTX-8064 in combination with pimivalimab (TNBC)
1 of 12
Stage 4, Expansion: JTX-8064 in combination with pimivalimab (cSCC)
1 of 12
Stage 4, Expansion: JTX-8064 in combination with pimivalimab (Ovarian)
1 of 12
Stage 4, Expansion: JTX-8064 in combination with pimivalimab (UPS & LPS)
1 of 12
Stage 4, Expansion: JTX-8064 in combination with pimivalimab (BTC)
1 of 12
Stage 1, Dose Escalation: JTX-8064 monotherapy dose escalation
1 of 12
Stage 3 Expansion: JTX-8064 monotherapy (Ovarian)
1 of 12
Stage 2, Dose Escalation: JTX-8064 in combination with pimivalimab
1 of 12
Stage 4, Expansion: JTX-8064 in combination with pimivalimab (NSCLC)
1 of 12
Stage 4, Expansion: JTX-8064 in combination with pimivalimab (HNSCC)
1 of 12
Stage 4, Expansion: JTX-8064 in combination with pimivalimab (PD-(L)1i-experienc...
1 of 12

Experimental Treatment

281 Total Participants · 12 Treatment Groups

Primary Treatment: JTX-8064 · No Placebo Group · Phase 1 & 2

Stage 4, Expansion: JTX-8064 in combination with pimivalimab (ccRCC)Experimental Group · 2 Interventions: pimivalimab, JTX-8064 · Intervention Types: Drug, Drug
Stage 4, Expansion: JTX-8064 in combination with pimivalimab (TNBC)Experimental Group · 2 Interventions: pimivalimab, JTX-8064 · Intervention Types: Drug, Drug
Stage 4, Expansion: JTX-8064 in combination with pimivalimab (cSCC)Experimental Group · 2 Interventions: pimivalimab, JTX-8064 · Intervention Types: Drug, Drug
Stage 4, Expansion: JTX-8064 in combination with pimivalimab (Ovarian)Experimental Group · 2 Interventions: pimivalimab, JTX-8064 · Intervention Types: Drug, Drug
Stage 4, Expansion: JTX-8064 in combination with pimivalimab (UPS & LPS)Experimental Group · 2 Interventions: pimivalimab, JTX-8064 · Intervention Types: Drug, Drug
Stage 4, Expansion: JTX-8064 in combination with pimivalimab (BTC)Experimental Group · 2 Interventions: pimivalimab, JTX-8064 · Intervention Types: Drug, Drug
Stage 1, Dose Escalation: JTX-8064 monotherapy dose escalation
Drug
Experimental Group · 1 Intervention: JTX-8064 · Intervention Types: Drug
Stage 3 Expansion: JTX-8064 monotherapy (Ovarian)
Drug
Experimental Group · 1 Intervention: JTX-8064 · Intervention Types: Drug
Stage 2, Dose Escalation: JTX-8064 in combination with pimivalimabExperimental Group · 2 Interventions: pimivalimab, JTX-8064 · Intervention Types: Drug, Drug
Stage 4, Expansion: JTX-8064 in combination with pimivalimab (NSCLC)Experimental Group · 2 Interventions: pimivalimab, JTX-8064 · Intervention Types: Drug, Drug
Stage 4, Expansion: JTX-8064 in combination with pimivalimab (HNSCC)Experimental Group · 2 Interventions: pimivalimab, JTX-8064 · Intervention Types: Drug, Drug
Stage 4, Expansion: JTX-8064 in combination with pimivalimab (PD-(L)1i-experienced HNSCC)Experimental Group · 2 Interventions: pimivalimab, JTX-8064 · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months

Who is running the clinical trial?

Jounce Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
400 Total Patients Enrolled
Adam Y-Beltrán, M.DStudy DirectorJounce Therapeutics, Inc.
Elizabeth Trehu, M.DStudy DirectorJounce Therapeutics, Inc.

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 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.
You have a histologically or cytologically confirmed advanced/metastatic extracranial solid tumor malignancy.
You have 3L/4L PD-(L)1-naïve, platinum-resistant ovarian cancer.
Subjects must have progressed on or after treatment with a prior anti-PD-(L)1 therapy.
You have a positive PD-L1 expression
You have 3L/4L ovarian cancer.
Subjects must have progressed on or after treatment with platinum-based chemotherapy and an anti-PD-(L)1-containing therapy
References

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top