RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing GI-102 for Metastatic Castration-resistant Prostate Cancer (mCRPC)

The purpose of this clinical trial is to measure 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).

Official registry: https://clinicaltrials.gov/study/NCT07871435 · GI Innovation, Inc. · enrollment listed as 107

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are GI-102, or Pasritamig. The registry lists allocation as randomized. The purpose of this clinical trial is to measure 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).

They plan to enroll about 107 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 1b/2, Open-label, Multi-center Study to Evaluate the Anti-cancer Activity, Safety and Tolerability of GI-102 (CD80-IgG4 Fc-IL2v3) in Combination With Pasritamig [T-CELL-Redirecting Agent Targeting Human Kallikrein 2 (KLK2)] in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Progressed on Previous Novel Hormonal Therapy (NHT) (JET-201)

Interventions: GI-102, Pasritamig

Primary outcome (registry wording): Incidence and nature of DLTs (Safety run-in phase)

Who it is for (from inclusion criteria)

Ages 18 Years to any
Men only
Male participants aged ≥18 years (or ≥19 years according to local regulatory requirements)
how well you can do daily activities (ECOG score) of 0 to 1
Metastatic castration-resistant prostate cancer (mCRPC) with documented disease progression following at least one line of novel androgen receptor-targeted therapy
PSA ≥2 ng/mL at screening
No more than 2 prior taxane regimens and no prior cytotoxic chemotherapy other than taxane therapy
Prior orchiectomy or ongoing androgen deprivation therapy with castrate testosterone levels
Adequate organ and marrow function and adequate cardiovascular function

Who the registry excludes

Active or prior CNS metastases, carcinomatous meningitis, or clinically unstable spinal cord compression
Significant uncontrolled cardiovascular, pulmonary, hepatic, autoimmune, infectious, or other systemic disease
Active or recent clinically significant infection, including active tuberculosis, hepatitis B, or hepatitis C
Active pneumonitis or interstitial lung disease (ILD), or history of clinically significant pneumonitis/ILD
Recent treatment with investigational products, prohibited immunomodulating agents, radiotherapy, major surgery, or other protocol-defined prohibited therapies
Prior treatment with CD3-directed therapies, including KLK2-CD3 bispecific antibodies or other CD3-targeting T-cell engagers
Known hypersensitivity to GI-102, pasritamig, or their excipients, or any other condition that may interfere with study participation or interpretation of results

Public study contact (from the registry)

Kwang-Soo Shin

+82-2-404-2003

Clinical-102-P201@gi-innovation.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

6 listed

Columbia University Medical Center — New York, New York (not_yet_recruiting)

+ 5 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07871435 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07871435?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07871435?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary