Actively Recruiting
RC48 Monotherapy or Combination With Envafolimab for CDK12 Alterations mCRPC With Standard Treatment Failure
Led by Tianjin Medical University Second Hospital · Updated on 2024-10-29
72
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RC48 Monotherapy or Combination With Envafolimab for CDK12 Alterations mCRPC With Standard Treatment Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and follow study procedures and provide written consent
- Male patients aged 18 years or older
- Confirmed non-resectable or metastatic HER2 positive castration resistant prostate cancer
- Carry CDK12 mutation combined with ERBB amplification or HER2 IHC (1+, 2+, 3+)
- At least one measurable tumor lesion according to RECIST criteria
- ECOG performance status of 0-2
- Expected survival of at least 12 weeks
- Prior treatment with at least one novel endocrine therapy and PARP inhibitor treatment
- No prior use of HER2 targeted drugs including antibodies or small molecule TKIs
- Normal main organ functions including blood counts, liver and kidney function, and cardiac function
- Willing to participate voluntarily with good compliance and follow-up cooperation
You will not qualify if you...
- History of allergies to study drug components
- Other malignant tumors within past 5 years except certain treated skin cancers or cured tumors
- Presence of brain metastases or cancerous meningitis
- Previous allogeneic stem cell or organ transplantation
- Congenital or acquired immunodeficiency
- Known allergies to vediximab, paclitaxel-like drugs, chimeric or humanized antibodies, or study drug excipients
- Significant clinical or lab abnormalities affecting safety evaluation such as uncontrolled diabetes, hypertension, liver cirrhosis, lung diseases, kidney disease, neuropathy grade II or above, thyroid dysfunction, or severe heart failure
- Active or poorly controlled severe infections including HIV, active hepatitis B or C, tuberculosis, or other infections grade 2 or above
- Severe heart disease or untreatable discomfort
- Mental illness or substance abuse preventing cooperation
- Participation in other clinical trials
- Investigator judgment of unsuitability for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin Municipality, China, 300211
Actively Recruiting
Research Team
H
Haitao Wang, Ph.D
CONTACT
J
Jinhuan Wang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here