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RECRUITING
NCT06663007
PHASE1/PHASE2

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

Sponsor: Tianjin Medical University Second Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2024-09-24

Completion Date

2027-08-31

Last Updated

2024-10-29

Healthy Volunteers

No

Interventions

DRUG

RC48

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.

DRUG

Envafolimab

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