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

November 4, 2026 updated by: GI Innovation, Inc.

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)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
107

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center
        • Principal Investigator:
          • Jae Lyun Lee, M.D., Ph.D.
      • Seoul, South Korea, 03722
        • Recruiting
        • Yonsei University Health System, Severance Hospital
        • Principal Investigator:
          • Sang Joon Shin, M.D., Ph.D.
    • Banpo-daero
      • Seoul, Banpo-daero, South Korea, 06591
        • Recruiting
        • The Catholic University of Korea Seoul ST.MARY'S Hospital
        • Principal Investigator:
          • In Ho Kim
    • Seongbuk-gu
      • Seoul, Seongbuk-gu, South Korea, 02841
        • Recruiting
        • Korea University Anam Hospital
        • Principal Investigator:
          • Jwa Hoon Kim, M.D.
    • Yangcheon-gu
      • Seoul, Yangcheon-gu, South Korea, 07985
        • Recruiting
        • Ewha Womans University Mokdong Hospital
        • Principal Investigator:
          • Jeong Min Cho
  • United States
    • New York
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Columbia University Medical Center
        • Principal Investigator:
          • Mark N. Stein, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Safety run-in: GI-102 + pasritamig (Schedule A)

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.
Drug: GI-102

GI-102 will be administered in accordance with the procedures specified in the study protocol.

Drug: Pasritamig

Pasritamig will be administered in accordance with the procedures specified in the study protocol.
Experimental: Safety run-in: GI-102 + pasritamig (Schedule B)

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.
Drug: GI-102

GI-102 will be administered in accordance with the procedures specified in the study protocol.

Drug: Pasritamig

Pasritamig will be administered in accordance with the procedures specified in the study protocol.
Experimental: Expansion

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.
Drug: GI-102

GI-102 will be administered in accordance with the procedures specified in the study protocol.

Drug: Pasritamig

Pasritamig will be administered in accordance with the procedures specified in the study protocol.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence and nature of DLTs (Safety run-in phase)
Time Frame: 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).
From Day -14 to Cycle 1 Day 22 (35 days)
Incidence, nature, and severity of AEs graded according to CTCAE v6.0 (Safety run-in phase)
Time Frame: 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.
Up to 2 years
PSA response rate (≥ 50% decline from baseline) per PCWG3 (Expansion phase)
Time Frame: 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.
Up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PSA response rate (≥ 50% and ≥ 90% decline from baseline) per PCWG3 (Safety run-in phase)
Time Frame: Up to 2 years

PSA response rate is defined as the percentage of participants with a decline of PSA of 50% (or 90%) or more from baseline.
Up to 2 years
Radiographic PFS per PCWG3
Time Frame: Up to 2 years

Radiographic PFS is defined as the time from the date of first dose of any study treatment until the date of radiographic disease progression or death, whichever comes first.
Up to 2 years
Time to PSA progression
Time Frame: Up to 2 years

Time to PSA progression, defined as the time from baseline to the first date of documented PSA progression per PCWG3 criteria.
Up to 2 years
Overall Response Rate (ORR) per RECIST v1.1
Time Frame: Up to 2 years

Among participants with measurable disease, ORR is defined as the percentage of participants who achieve a partial response (PR) or complete response (CR) according to RECIST v1.1.
Up to 2 years
Duration of Response (DoR) per RECIST v1.1
Time Frame: Up to 2 years

Among participants with measurable disease who achieve a CR or PR, DoR is defined as the time from the first documented CR or PR until the first documented disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.
Up to 2 years
Disease Control Rate (DCR) per RECIST v1.1
Time Frame: Up to 2 years

Among participants with measurable disease, DCR is defined as the percentage of participants who achieve a CR, PR, or stable disease (SD) according to RECIST v1.1.
Up to 2 years
Incidence, nature, and severity of AEs graded according to CTCAE v6.0 (Expansion phase)
Time Frame: 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.
Up to 2 years
PK profile: peak plasma concentration (Cmax) of GI-102 when combined with pasritamig
Time Frame: Up to 2 years

Plasma concentrations of GI-102 will be measured at specified time points following administration of GI-102 in combination with pasritamig to determine the maximum observed plasma concentration (Cmax).
Up to 2 years
PK profile: half-life (T1/2) of GI-102 when combined with pasritamig
Time Frame: Up to 2 years

Plasma concentrations of GI-102 will be measured at specified time points following administration of GI-102 in combination with pasritamig to determine the terminal half-life (T1/2) of GI-102.
Up to 2 years
PK profile: area under the plasma concentration-time curve (AUC) of GI-102 when combined with pasritamig
Time Frame: Up to 2 years

Plasma concentrations of GI-102 will be measured at specified time points following administration of GI-102 in combination with pasritamig to determine the area under the plasma concentration-time curve (AUC) of GI-102.
Up to 2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Immune cell phenotyping in peripheral blood
Time Frame: Up to 2 years

Immune cell populations and their changes following study treatment will be assessed in peripheral blood using flow cytometry.
Up to 2 years
Overall Response Rate (ORR) per iRECIST
Time Frame: Up to 2 years

ORR is defined as the percentage of participants who achieve a partial response (PR) or complete response (CR) according to the iRECIST criteria.
Up to 2 years
Overall Survival (OS)
Time Frame: Up to 2 years

Overall survival (OS) is defined as the time from the first dose of study treatment to death from any cause.
Up to 2 years
Incidence of anti-GI-102 antibody (ADA)
Time Frame: Up to 2 years

Serum samples will be analyzed using a validated assay to determine the incidence of anti-GI-102 antibodies (ADA).
Up to 2 years
Incidence of Neutralizing Antibody (Nab) Against GI-102
Time Frame: Up to 2 years

Serum samples that are positive for anti-GI-102 antibodies (ADA) will be further analyzed using a validated assay to determine the incidence of neutralizing antibodies (Nab).
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GI Innovation, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GII-102-P201 (JET-201)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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