Two-Drug immunotherapy combo targets advanced prostate cancer
NCT ID NCT07871435
First seen Oct 13, 2026 · Last updated Oct 20, 2026 · Updated 3 times
Summary
Researchers are testing a combination of two experimental immunotherapy drugs, GI-102 and pasritamig, in men with metastatic castration-resistant prostate cancer that has worsened after hormone therapy. The trial aims to see if the combination is safe and can lower PSA levels or slow tumor growth. About 107 adult men will receive both drugs by IV infusion. The study is in early phases, so its main goal is to assess safety and early signs of benefit.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GI-102 combined with pasritamig, two experimental immunotherapy drugs given by IV infusion
- What this could lead to
- If the combination works, it could offer a new treatment option for men whose prostate cancer has grown despite hormone therapy.
- What could go wrong
- This is an early-stage trial with about 107 participants, so it may not show clear benefit. Combining two immune-based drugs can cause serious side effects, and results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 107 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asan Medical Center
NOT_YET_RECRUITINGSeoul, 05505, South Korea
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Columbia University Medical Center
NOT_YET_RECRUITINGNew York, New York, 10032, United States
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Ewha Womans University Mokdong Hospital
RECRUITINGSeoul, Yangcheon-gu, 07985, South Korea
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Korea University Anam Hospital
NOT_YET_RECRUITINGSeoul, Seongbuk-gu, 02841, South Korea
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The Catholic University of Korea Seoul ST.MARY'S Hospital
NOT_YET_RECRUITINGSeoul, Banpo-daero, 06591, South Korea
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Yonsei University Health System, Severance Hospital
RECRUITINGSeoul, 03722, South Korea
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- New Immune-Boosting drug combo targets Hard-to-Treat cancers
- New prostate cancer drug enters first human trials
- CBD may cut opioid need in advanced prostate cancer