Metastatic Castration-resistant Prostate Cancer (mCRPC)Phase 1/2NCT07871435
GI-102 (CD80-IgG4 Fc-IL2v3) in Combination With Pasritamig in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) (JET-201)
A Phase 1/2 study testing GI-102 and Pasritamig in people with Metastatic Castration-resistant Prostate Cancer (mCRPC), run by GI Innovation, Inc. at 6 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer (mCRPC)
- What is being tested?
- GI-102 and Pasritamig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 12 Oct 2026to 30 Sep 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 join
- 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.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
South Korea5 sites, 5 recruiting
- Not yet recruiting
The Catholic University of Korea Seoul ST.MARY'S Hospital
Seoul, Banpo-daero, 06591
In Ho Kim
- Not yet recruiting
Korea University Anam Hospital
Seoul, Seongbuk-gu, 02841
Jwa Hoon Kim, M.D.
- Recruiting
Ewha Womans University Mokdong Hospital
Seoul, Yangcheon-gu, 07985
Jeong Min Cho
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul, 03722
Sang Joon Shin, M.D., Ph.D.
- Not yet recruiting
Asan Medical Center
Seoul, 05505
Jae Lyun Lee, M.D., Ph.D.
United States1 site, 1 recruiting
- Not yet recruiting
Columbia University Medical Center
New York, New York, 10032
Mark N. Stein, M.D.
About this study
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)
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).
- Being tested
- GI-102, Pasritamig
- Keywords
- Metastatic castration-resistant prostate cancer, Immunotherapy, GI-102, CD80-IgG4 Fc-IL2 variant, Interleukin-2, Immunocytokine, bispecific protein, pasritamig, T cell engager
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI-102Drug
GI-102 will be administered via IV infusion
PasritamigDrug
Pasritamig will be administered via IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Safety run-in: GI-102 Q6W + pasritamig | Experimental | Participants receive GI-102 every 6 weeks (Q6W) in combination with pasritamig at its recommended Phase 2 dose (RP2D) during the Safety run-in phase. Dose escalation is guided by a Bayesian Optimal Interval (BOIN) design. Receives: Drug: GI-102; Drug: Pasritamig |
| Safety run-in: GI-102 Q3W + pasritamig | Experimental | Participants receive GI-102 every 3 weeks (Q3W) in combination with pasritamig at its recommended Phase 2 dose (RP2D) during the Safety run-in phase. Dose escalation is guided by a Bayesian Optimal Interval (BOIN) design. Receives: Drug: GI-102; Drug: Pasritamig |
| Expansion | Experimental | 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. Receives: Drug: GI-102; Drug: Pasritamig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of DLTs (Safety run-in phase)
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).
Measured: 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)
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.
Measured: Up to 2 years
PSA response rate (≥ 50% decline from baseline) per PCWG3 (Expansion phase)
PSA response rate is defined as the percentage of participants with a decline of PSA of 50% or more from baseline.
Measured: Up to 2 years
Secondary outcomes (10)
PSA response rate (≥ 50% and ≥ 90% decline from baseline) per PCWG3 (Safety run-in phase)
PSA response rate is defined as the percentage of participants with a decline of PSA of 50% (or 90%) or more from baseline.
Measured: Up to 2 years
Radiographic PFS per PCWG3
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.
Measured: Up to 2 years
Time to PSA progression
Time to PSA progression, defined as the time from baseline to the first date of documented PSA progression per PCWG3 criteria.
Measured: Up to 2 years
Overall Response Rate (ORR) per RECIST v1.1
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.
Measured: Up to 2 years
Duration of Response (DoR) per RECIST v1.1
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.
Measured: Up to 2 years
Disease Control Rate (DCR) per RECIST v1.1
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.
Measured: Up to 2 years
Incidence, nature, and severity of AEs graded according to CTCAE v6.0 (Expansion phase)
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.
Measured: Up to 2 years
PK profile: peak plasma concentration (Cmax) of GI-102 when combined with pasritamig
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).
Measured: Up to 2 years
PK profile: half-life (T1/2) of GI-102 when combined with pasritamig
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.
Measured: Up to 2 years
PK profile: area under the plasma concentration-time curve (AUC) of GI-102 when combined with pasritamig
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start12 Oct 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Participants are assigned to receive GI-102 in combination with pasritamig sequentially across different dose levels during the Safety run-in phase based on safety and dose-escalation decisions. Participants may subsequently be enrolled in the Expansion phase at the combination recommended Phase 2 dose.
- Masking
- None (open label)
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GI Innovation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871435
- Sponsor's protocol ID
- GII-102-P201 (JET-201)
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07871435
- Acronym / sponsor ID
- GII-102-P201 (JET-201)
- Keywords
- Metastatic castration-resistant prostate cancer, Immunotherapy, GI-102, CD80-IgG4 Fc-IL2 variant, Interleukin-2, Immunocytokine, bispecific protein, pasritamig
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- GI Innovation, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 12 Oct 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are assigned to receive GI-102 in combination with pasritamig sequentially across different dose levels during the Safety run-in phase based on safety and dose-escalation decisions. Participants may subsequently be enrolled in the Expansion phase at the combination recommended Phase 2 dose.
| Arm | Type | Receives |
|---|---|---|
| Safety run-in: GI-102 Q6W + pasritamig | Experimental | Drug: GI-102, Drug: PasritamigParticipants receive GI-102 every 6 weeks (Q6W) in combination with pasritamig at its recommended Phase 2 dose (RP2D) during the Safety run-in phase. Dose escalation is guided by a Bayesian Optimal Interval (BOIN) design. |
| Safety run-in: GI-102 Q3W + pasritamig | Experimental | Drug: GI-102, Drug: PasritamigParticipants receive GI-102 every 3 weeks (Q3W) in combination with pasritamig at its recommended Phase 2 dose (RP2D) during the Safety run-in phase. Dose escalation is guided by a Bayesian Optimal Interval (BOIN) design. |
| Expansion | Experimental | Drug: GI-102, Drug: PasritamigParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GI-102GI-102 will be administered via IV infusion | Drug | Expansion, Safety run-in: GI-102 Q3W + pasritamig, Safety run-in: GI-102 Q6W + pasritamig |
| PasritamigPasritamig will be administered via IV infusion. | Drug | Expansion, Safety run-in: GI-102 Q3W + pasritamig, Safety run-in: GI-102 Q6W + pasritamig |
Primary outcome
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.
10 secondary outcomes
PSA response rate (≥ 50% and ≥ 90% decline from baseline) per PCWG3 (Safety run-in phase)
Time frame: Up to 2 years
Radiographic PFS per PCWG3
Time frame: Up to 2 years
Time to PSA progression
Time frame: Up to 2 years
Overall Response Rate (ORR) per RECIST v1.1
Time frame: Up to 2 years
Duration of Response (DoR) per RECIST v1.1
Time frame: Up to 2 years
Disease Control Rate (DCR) per RECIST v1.1
Time frame: Up to 2 years
Incidence, nature, and severity of AEs graded according to CTCAE v6.0 (Expansion phase)
Time frame: Up to 2 years
PK profile: peak plasma concentration (Cmax) of GI-102 when combined with pasritamig
Time frame: Up to 2 years
PK profile: half-life (T1/2) of GI-102 when combined with pasritamig
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GI-102 and Pasritamig in people with Metastatic Castration-resistant Prostate Cancer (mCRPC), run by GI Innovation, Inc. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kwang-Soo Shin (+82-2-404-2003, Clinical-102-P201@gi-innovation.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and nature of DLTs (Safety run-in phase) (time frame: From Day -14 to Cycle 1 Day 22 (35 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.