OncoMatch/Clinical Trials/NCT06663007
RC48 Monotherapy or Combination With Envafolimab for CDK12 Alterations mCRPC With Standard Treatment Failure
Is NCT06663007 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including RC48 and Envafolimab for prostate cancer.
Treatment: RC48 · Envafolimab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Prostate Cancer
Biomarker criteria
Required: CDK12 mutation
Carrying CDK12 mutation combined with ERBB amplification (NGS or FISH) or HER2 IHC (1+, 2+, 3+)
Required: HER2 (ERBB2) amplification
Carrying CDK12 mutation combined with ERBB amplification (NGS or FISH) or HER2 IHC (1+, 2+, 3+)
Required: HER2 (ERBB2) IHC 1+ (IHC 1+)
HER2 IHC (1+, 2+, 3+)
Required: HER2 (ERBB2) IHC 2+ (IHC 2+)
HER2 IHC (1+, 2+, 3+)
Required: HER2 (ERBB2) IHC 3+ (IHC 3+)
HER2 IHC (1+, 2+, 3+)
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: novel endocrine therapy (abiraterone, enzalutamide, darotamine, apatamide, rivalutamide)
Prior exposure to at least one novel endocrine therapy (including abiraterone, enzalutamide, darotamine, apatamide, and rivalutamide)
Must have received: PARP inhibitor
depletion of PARPi treatment
Cannot have received: HER2-targeted therapy
Have not used HER2 targeted drugs (including antibodies, small molecule TKIs, and antibody drug conjugates)
Lab requirements
Blood counts
Hb ≥ 90g/L (no blood transfusion or blood products within 14 days, no correction with G-CSF or other hematopoietic stimulating factors); ANC≥1.5×10^9/L; PLT≥90×10^9/L
Kidney function
BUN and Cr ≤ 1.5 × ULN
Liver function
TBiL≤1×ULN; ALT and AST ≤ 1.5 × ULN; ALP≤2.5×ULN
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50%
The main organ functions are normal, which meets the following criteria: ... blood routine ... biochemical tests ... cardiac ultrasound
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06663007 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior HER2-targeted therapy disqualifies patients from enrollment.
Does this trial require CDK12?
Yes, CDK12 mutation is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 amplification is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 IHC 1+ is a required biomarker for enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages