NCT06663007 RC48 Monotherapy or Combination With Envafolimab for CDK12 Alterations mCRPC With Standard Treatment Failure
| NCT ID | NCT06663007 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Tianjin Medical University Second Hospital |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2024-09-24 |
| Primary Completion | 2027-05-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
Inclusion Criteria: 1. Participants must be able to understand the procedures and methods of this study, willing to strictly follow the clinical trial protocol to complete the trial, and voluntarily sign a written informed consent form; 2. Patients aged ≥ 18 years old; 3. Pathological examination confirms non resectable or metastatic HER2 positive castration resistant prostate cancer (mCRPC): HER2 positive is defined as IHC 3+or IHC 2+or FISH+; 4. Carrying CDK12 mutation combined with ERBB amplification (NGS or FISH) or HER2 IHC (1+, 2+, 3+); 5. According to the RECIST solid tumor efficacy evaluation criteria, there must be at least one measurable lesion; 6. ECOG PS: 0-2 points; 7. Expected survival period is not less than 12 weeks; 8. Prior exposure to at least one novel endocrine therapy (including abiraterone, enzalutamide, darotamine, apatamide, and rivalutamide) and depletion of PARPi treatment (if AVPC/NEPC, platinum chemotherapy resistance or intolerance is required); 9. Have no
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