Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Phase 1/2

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

NCT07871435 · tracked via the Priya Life Science USA tracker
Phase
Phase 1/2
Started
2026-10-12
Last updated
2026-10-19

Condition(s) studied

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Investigational drug(s) / intervention(s)

GI-102 →Pasritamig →

GI-102: GI-102 will be administered via IV infusion

Pasritamig: Pasritamig will be administered via IV infusion.

Study 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).

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence and nature of DLTs (Safety run-in phase) — From Day -14 to Cycle 1 Day 22 (35 days)
    A DLT is defined as a clinically significant AE (classified according to the NCI CTCAE version 6.0) or significant laboratory abnormality that occur during the DLT assessment periods, and is considered by the Investigator to be related to the study drug(s).
  • Incidence, nature, and severity of AEs graded according to CTCAE v6.0 (Safety run-in phase) — Up to 2 years
    An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. All AE events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
  • PSA response rate (≥ 50% decline from baseline) per PCWG3 (Expansion phase) — Up to 2 years
    PSA response rate is defined as the percentage of participants with a decline of PSA of 50% or more from baseline.

Trial sites (6)

FacilityCityRegionStatus
Columbia University Medical Center New York New York Not Yet Recruiting
The Catholic University of Korea Seoul ST.MARY'S Hospital Seoul Banpo-daero Not Yet Recruiting
Korea University Anam Hospital Seoul Seongbuk-gu Not Yet Recruiting
Ewha Womans University Mokdong Hospital Seoul Yangcheon-gu Recruiting
Yonsei University Health System, Severance Hospital Seoul South Korea Recruiting
Asan Medical Center Seoul South Korea Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07871435 on ClinicalTrials.gov ↗ ← All trials in the USA