A Phase 1/2 interventional study of GI-102 and Pasritamig in Metastatic Castration-resistant Prostate Cancer (mCRPC), sponsored by GI Innovation, Inc.. Recruiting at 6 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by GI Innovation, Inc. · Phase 1/2, Interventional, and Treatment
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).
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 107 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →GI Innovation, Inc. is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 will be administered in accordance with the procedures specified in the study protocol.
Pasritamig will be administered in accordance with the procedures specified in the study protocol.
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).
Time frame: 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.
Time frame: 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.
Time frame: Up to 2 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Up to 2 years
Immune cell phenotyping in peripheral blood
Immune cell populations and their changes following study treatment will be assessed in peripheral blood using flow cytometry.
Time frame: Up to 2 years
Overall Response Rate (ORR) per iRECIST
ORR is defined as the percentage of participants who achieve a partial response (PR) or complete response (CR) according to the iRECIST criteria.
Time frame: Up to 2 years
Overall Survival (OS)
Overall survival (OS) is defined as the time from the first dose of study treatment to death from any cause.
Time frame: Up to 2 years
Incidence of anti-GI-102 antibody (ADA)
Serum samples will be analyzed using a validated assay to determine the incidence of anti-GI-102 antibodies (ADA).
Time frame: Up to 2 years
Incidence of Neutralizing Antibody (Nab) Against GI-102
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).
Time frame: Up to 2 years
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Bispecific CD80-lgG4Fc-IL-2v Fusion Protein GI-102
GI Innovation, Inc.