GI-102 (CD80-IgG4 Fc-IL2v3) in Combination With Pasritamig in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) (JET-201)
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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests GI-102 with pasritamig to see how safe the drugs are, how well men tolerate them, and whether they may fight cancer. It is for adult men with prostate cancer that has spread and keeps growing despite very low testosterone, after treatment with a newer hormone therapy.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Men age 18 or older, or 19 or older where local rules require it.
- Able to do everyday tasks with little or no limit on physical activity.
- Have advanced prostate adenocarcinoma confirmed by a tissue test, with cancer that can be measured or checked. Some small cell or neuroendocrine features are allowed, but certain cancer types are not.
- Cancer has spread and worsened after at least one newer hormone treatment. The PSA blood test result must be at least 2 ng/mL.
- Had no more than 2 courses of taxane chemotherapy and no other cell-killing chemotherapy.
- Have very low testosterone after surgery to remove the testicles or while taking treatment to lower testosterone.
- Have well enough working organs, heart, and bone marrow, which makes blood cells. Have recovered enough from side effects of earlier cancer treatment.
- Willing and able to follow study steps and birth control rules.
Who can't join
- Current or past cancer spread to the brain or spinal cord, cancer in their lining, or unstable pressure on the spinal cord.
- Serious uncontrolled heart, lung, liver, immune system, infection-related, or other illness.
- An active or recent serious infection, including active tuberculosis, hepatitis B, or hepatitis C.
- Current lung inflammation or disease that scars the lungs, or a history of serious forms of these conditions.
- Recent treatment with experimental drugs, certain drugs that affect the immune system, radiation, major surgery, or other treatments not allowed by the study.
- Past treatment with drugs that target CD3, a marker on immune cells. This includes KLK2-CD3 antibodies and other CD3-targeting treatments.
- Known allergy to GI-102, pasritamig, or their ingredients, or another condition that could affect study participation or results.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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.
Study sites (1)
NY
- Columbia University Medical Center · New York, NY 10032Mark N. Stein, M.D. · Principal investigatorMore trials in New York