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GI-102 (CD80-IgG4 Fc-IL2v3) in Combination With Pasritamig in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) (JET-201)
Sponsor: GI Innovation, Inc.
Summary
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).
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)
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
107
Start Date
2026-10-12
Completion Date
2029-09-30
Last Updated
2026-10-19
Healthy Volunteers
No
Interventions
GI-102
GI-102 will be administered via IV infusion
Pasritamig
Pasritamig will be administered via IV infusion.
Locations (6)
Columbia University Medical Center
New York, New York, United States
The Catholic University of Korea Seoul ST.MARY'S Hospital
Seoul, Banpo-daero, South Korea
Korea University Anam Hospital
Seoul, Seongbuk-gu, South Korea
Ewha Womans University Mokdong Hospital
Seoul, Yangcheon-gu, South Korea
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea