GI-102 Plus Pasritamig for Metastatic Castration-Resistant Prostate Cancer After Hormone Therapy
Tests GI-102 with pasritamig in men whose prostate cancer progressed after hormone therapy.
Plain-language title generated from the registry record
Registry title: GI-102 (CD80-IgG4 Fc-IL2v3) in Combination With Pasritamig in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) (JET-201)
Key facts
- Where
- New York, United StatesSee the site
- Phase
- Phase 1/2
Where in United States
- Columbia University Medical CenterNew York, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- GI Innovation, Inc.
- Trial code
- NCT07871435
- Record updated
- 9 November 2026
- Original description
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).Read full original descriptionShow less
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)
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).
Inclusion: 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.
Exclusion: Active or prior CNS metastases, carcinomatous meningitis, or clinically unstable spinal cord compression; 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; 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; Known hypersensitivity to GI-102, pasritamig, or their excipients, or any other condition that may interfere with study participation or interpretation of results.