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Taking peoplePhase 1/2

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.

Key facts

Who runs it
GI Innovation, Inc.
Where
New York, United StatesSee the siteAlso in 1 other country, 5 sites
Trial code
Registry title
GI-102 (CD80-IgG4 Fc-IL2v3) in Combination With Pasritamig in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) (JET-201)
Status
Recruiting
Phase
Phase 1/2
People taking part
107 people, planned
Started
12 Oct 2026
Expected to end
30 Sept 2029
Type of study
Interventional, 3 groups
Treatments tested
  • GI-102
  • Pasritamig
Record updated
9 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men with advanced prostate cancer that has spread and no longer responds to hormone-lowering treatment. Their cancer must have grown after a newer hormone treatment.

Age
18 years or older (19 or older where local rules require it).
Sex
Men only.
Disease stage
Metastatic castration-resistant prostate cancer (mCRPC) with measurable or evaluable disease, ECOG performance status 0 to 1, and PSA of 2 ng/mL or more at screening. Primary small cell carcinoma, carcinoid tumor, mixed NE carcinoma or large cell NE carcinoma is not allowed.
Earlier treatment
Cancer must have progressed after at least one line of novel androgen receptor-targeted therapy. No more than 2 prior taxane regimens and no other cytotoxic chemotherapy. Prior orchiectomy or ongoing androgen deprivation therapy with castrate testosterone levels. Prior CD3-directed therapies, including KLK2-CD3 bispecific antibodies, are not allowed.

Main reasons for not taking part

  • Active or past brain or spinal cord spread of cancer, or carcinomatous meningitis, or unstable spinal cord compression
  • Serious uncontrolled heart, lung, liver, autoimmune, infectious or other body-wide disease
  • Active or recent significant infection, including active tuberculosis, hepatitis B or hepatitis C
  • Active pneumonitis or interstitial lung disease, or past significant pneumonitis or ILD
  • Prior CD3-directed therapy, or known allergy to GI-102, pasritamig or their ingredients

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in United States

Also in 1 other country, 5 sites

  • Columbia University Medical CenterNew York, United StatesContact: Mark N. Stein, M.D. (principal investigator)Not yet recruiting

About the trial

What the trial wants to find out

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).

The 3 groups in the trial

  • Safety run-in: GI-102 + pasritamig (Schedule A)Treatment being tested

    Participants receive GI-102 in combination with pasritamig during the Safety run-in phase. Dose escalation is guided by a Bayesian Optimal Interval (BOIN) design.

    Treatment: GI-102 and Pasritamig

  • Safety run-in: GI-102 + pasritamig (Schedule B)Treatment being tested

    Participants receive GI-102 in combination with pasritamig during the Safety run-in phase. Dose escalation is guided by a Bayesian Optimal Interval (BOIN) design.

    Treatment: GI-102 and Pasritamig

  • ExpansionTreatment being tested

    Participants enrolled in the Expansion phase will receive the combination recommended Phase 2 regimen (cRP2R) of GI-102 and pasritamig, determined based on the safety and dose-escalation results from the Safety run-in phase.

    Treatment: GI-102 and Pasritamig

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
GI-102 Plus Pasritamig for Metastatic Castration-Resistant Prostate Cancer After Hormone TherapyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
9 November 2026