JTX-8064 for Cancer

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

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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

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Trial Design

12 Treatment Groups

Stage 4, Expansion: JTX-8064 in combination with pimivalimab (ccRCC)
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Stage 4, Expansion: JTX-8064 in combination with pimivalimab (TNBC)
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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)
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Stage 1, Dose Escalation: JTX-8064 monotherapy dose escalation
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Stage 3 Expansion: JTX-8064 monotherapy (Ovarian)
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Stage 2, Dose Escalation: JTX-8064 in combination with pimivalimab
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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...
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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