RecruitingPhase 1NCT06344715

Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC.

A Phase 1, Multi-center, Open-label, Dose-escalating Study to Evaluate the Safety and Tolerability of Triple Combination Regimen of SL-T10, GX-I7 and Pembrolizumab in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)


Sponsor

SL VAXiGEN

Enrollment

78 participants

Start Date

Oct 17, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy and safety of SL-T10 and GX-I7 or SL-T10, GX-I7 and pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC).


Eligibility

Sex: MALEMin Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This early-phase safety study is testing a triple combination of two experimental immune-boosting drugs (SL-T10 and GX-I7) alongside pembrolizumab (a well-known immunotherapy drug) for men with prostate cancer that has spread and no longer responds to hormone therapy. The goal is to see if this combination is safe and tolerable. **You may be eligible if...** - You are a male aged 19 or older - You have been confirmed to have prostate cancer that has spread (to bones or soft tissue) and is no longer controlled by hormone therapy (testosterone below 50 ng/dL) - You have previously received docetaxel (a chemotherapy drug) plus at least one of: abiraterone acetate or enzalutamide - Your cancer has continued to progress despite prior treatment, shown by rising PSA levels, growing soft tissue tumors, or new bone lesions - You are on ongoing hormone-suppressing therapy **You may NOT be eligible if...** - You have an active autoimmune disease or are on immune-suppressing medications or steroids - You have had prior severe immune-related side effects from immunotherapy - You have uncontrolled brain metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSL-T10

A therapeutic DNA vaccine containing three prostate cancer-specific antigen genes and genetic adjuvants

BIOLOGICALGX-I7

A T-cell growth factor

BIOLOGICALPembrolizumab

An immune check point inhibitor


Locations(1)

Seoul National University Hospital

Seoul, South Korea

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NCT06344715


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