GI-102 (CD80-IgG4 Fc-IL2v3) in Combination With Pasritamig in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) (JET-201)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More GI Innovation, Inc. trials in the USA
Other trials for the same condition
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