GI-102 (CD80-IgG4 Fc-IL2v3) in Combination With Pasritamig in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) (JET-201)

Part of paid clinical trials in New York, New York.

Sponsor
GI Innovation, Inc.
Study ID
NCT07871435
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Metastatic Castration-resistant Prostate Cancer (mCRPC)

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GI-102 — DRUG
    GI-102 will be administered via IV infusion
  • Pasritamig — DRUG
    Pasritamig will be administered via IV infusion.

Study Details

The purpose of this clinical trial is to evaluate the safety, tolerability, and preliminary anti-cancer activity of GI-102 in combination with pasritamig in adult men with metastatic castration-resistant prostate cancer (mCRPC) whose cancer has progressed after previous treatment with a novel hormonal therapy (NHT).

Key Dates

First listed
Oct 13, 2026
Start date
Oct 12, 2026
Status verified
Oct 2026
Primary completion
Mar 31, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
107 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety run-in: GI-102 Q6W + pasritamig Q6W
    Participants receive GI-102 every 6 weeks (Q6W) in combination with pasritamig every 6 weeks (Q6W) during the Safety run-in phase. Dose escalation is guided by a Bayesian Optimal Interval (BOIN) design.
  • Experimental: Safety run-in: GI-102 Q3W + pasritamig Q6W
    Participants receive GI-102 every 3 weeks (Q3W) in combination with pasritamig every 6 weeks (Q6W) during the Safety run-in phase. Dose escalation is guided by a Bayesian Optimal Interval (BOIN) design.
  • Experimental: Expansion
    Participants enrolled in the Expansion phase will receive the combination cRP2D of GI-102 and pasritamig, with the GI-102 dosing schedule (Q3W or Q6W) selected based on the safety and dose-escalation results from the Safety run-in phase.

Primary Outcome Measure

Incidence and nature of DLTs (Safety run-in phase) [ Time Frame: From Day -14 to Cycle 1 Day 22 (35 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032
Mark N. Stein, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Columbia University Medical Center· New York, NY

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