GI-102 (CD80-IgG4 Fc-IL2v3) in Combination With Pasritamig in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) (JET-201)
Metastatic Castration-resistant Prostate Cancer (mCRPC)
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Age range
- 18 years - Not specified
- Sex eligible
- Male
- Healthy volunteers
- Not accepted
- Participants
- 107 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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).
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not randomized
- Masking
- No masking
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 · Drug: Pasritamig
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 · Drug: Pasritamig
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 · Drug: Pasritamig
GI-102 DRUG
GI-102 will be administered in accordance with the procedures specified in the study protocol.
Pasritamig DRUG
Pasritamig will be administered in accordance with the procedures specified in the study protocol.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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).
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.
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.
Secondary measures
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
Other measures
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.
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.
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.
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).
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).
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (6)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
6 locations
Columbia University Medical CenterNew York, New York, United StatesNot yet recruiting
The Catholic University of Korea Seoul ST.MARY'S HospitalSeoul, Banpo-daero, South KoreaRecruiting
Korea University Anam HospitalSeoul, Seongbuk-gu, South KoreaRecruiting
Ewha Womans University Mokdong HospitalSeoul, Yangcheon-gu, South KoreaRecruiting
Yonsei University Health System, Severance HospitalSeoul, South KoreaRecruiting
Asan Medical CenterSeoul, South KoreaRecruiting
Study team and timeline
- Lead sponsor
- GI Innovation, Inc.
- Study start
- Oct 12, 2026 Estimated
- Primary completion
- Mar 31, 2029 Estimated
- Study completion
- Sep 30, 2029 Estimated
- First posted
- Oct 13, 2026 Actual
- Last updated
- Nov 9, 2026 Actual
Official study contacts
Official study 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)
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 9, 2026