RecruitingPhase 1Phase 2NCT06663007

RC48 Monotherapy or Combination With Envafolimab for CDK12 Alterations mCRPC With Standard Treatment Failure

Prospective, Single Arm, Multi Cohort Clinical Study of Disitamab Vedotin(RC48) Monotherapy or Combination With Envafolimab for Second-line Treatment of CDK12 Alterations Metastatic Castration Resistant Prostate Cancer With Standard Treatment Failure


Sponsor

Tianjin Medical University Second Hospital

Enrollment

72 participants

Start Date

Sep 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study is to evaluate the efficacy and safety of vediximab monotherapy or in combination with enrolizumab for second-line treatment of CDK12 alterations mCRPC that has failed standard therapy. The research results are expected to provide new insights and breakthroughs for the treatment of advanced prostate cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a targeted antibody-drug therapy (RC48, which delivers chemotherapy directly to cancer cells that overexpress HER2) alone or combined with an immunotherapy drug (envafolimab, which helps the immune system attack cancer), in men with prostate cancer that is no longer responding to hormone therapy and has a specific gene change called a CDK12 mutation. **You may be eligible if...** - You are 18 or older - You have prostate cancer that has spread and is no longer responding to hormone-lowering treatments (castration-resistant) - Your tumor has been confirmed to be HER2-positive on a lab test - Your tumor has a CDK12 gene change combined with HER2 amplification or overexpression - You have already tried at least one newer hormone therapy (like abiraterone or enzalutamide) - You have never received HER2-targeted drugs before **You may NOT be eligible if...** - You have not received the required prior treatments - Your organ function (blood, liver, kidneys) does not meet the minimum requirements - You have previously received HER2-targeted therapy (antibodies, pills, or antibody-drug conjugates) - Your general health or performance status is too low to tolerate treatment 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

DRUGRC48

During the patient treatment phase, the subjects received intravenous infusion of Disitamab Vedotin(RC48) (2.0 mg/kg) every 2 weeks until disease progression or death occurred.

DRUGEnvafolimab

During the treatment phase of the patient, the subjects received subcutaneous injections of Envafolimab (400 mg) every 3 weeks until the patient experienced disease progression or death.


Locations(1)

Tianjin Medical Unversity Second Hospital

Tianjin, Tianjin Municipality, China

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NCT06663007


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