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Clinical trial Recruiting at 5 sites Phase1; Phase2 Interventional Ages 18 and up Men only

GI-102 with Pasritamig for metastatic prostate cancer

Official title: 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)

Run by GI Innovation, Inc. · NCT07871435 · Data updated 2026-11-12

This trial tests GI-102 together with Pasritamig to see if it is safe and may help men whose metastatic castration-resistant prostate cancer has progressed after prior hormonal therapy.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment107 (estimated)
SponsorGI Innovation, Inc.
Industry-sponsored
Drugs / interventionschemotherapy
Locations6 sites (New York, New York and 5 other locations)
StatusRecruiting
StartedOctober 12, 2026
Main results expectedMarch 31, 2029
Study endsSeptember 30, 2029
Registry record updatedNovember 9, 2026
Trial IDNCT07871435 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men aged 18 or older with mCRPC, ECOG 0-1, measurable or evaluable disease, progression after at least one line of novel hormonal therapy, and limited prior cytotoxic chemotherapy.

Probably not a fit

Patients with mixed neuroendocrine features not allowed, extensive prior chemotherapy beyond two taxane regimens, or inadequate organ function may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study combines GI-102, a CD80-IgG4 Fc-IL2 variant, with Pasritamig in adults with metastatic castration-resistant prostate cancer (mCRPC) that progressed after novel hormonal therapy. The trial includes Phase 1 to assess safety and tolerability, followed by Phase 2 to explore potential anti-cancer activity. Eligible participants are men with measurable or evaluable disease, adequate organ function, and limited prior chemotherapy exposure, including up to two taxane regimens. The study is conducted at multiple centers in the United States and Korea under GI Innovation, Inc. with Janssen Research & Development as a collaborator.

Why it matters

Potential benefit: If successful, participants could experience improved disease control and potential clinical benefit from the combination therapy.

How similar studies have gone: Previous approaches using immunotherapy combinations in prostate cancer have shown mixed results, making this approach exploratory and not yet proven.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Male participants aged ≥18 years (or ≥19 years according to local regulatory requirements).
* ECOG performance status of 0 to 1.
* Histologically confirmed advanced prostate adenocarcinoma with measurable or evaluable disease. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, primary small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma (or pathologic evidence of conversion to) is disallowed.
* 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.
* Adequate recovery from prior anticancer therapy-related adverse events.
* Willingness and ability to comply with study procedures and protocol-specified contraception requirements.

Key Exclusion Criteria:

* 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.

Where it's running

  • The Catholic University of Korea Seoul ST.MARY'S Hospital
    Seoul, Banpo-daero, South Korea     Recruiting
  • Korea University Anam Hospital
    Seoul, Seongbuk-gu, South Korea     Recruiting
  • Ewha Womans University Mokdong Hospital
    Seoul, Yangcheon-gu, South Korea     Recruiting
  • Yonsei University Health System, Severance Hospital
    Seoul, South Korea     Recruiting
  • Asan Medical Center
    Seoul, South Korea     Recruiting
  • Columbia University Medical Center
    New York, New York, United States     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Metastatic Castration-resistant Prostate Cancer (mCRPC) 19GI Innovation, Inc. 5
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.