A Phase I Trial of A-CAR032 in Participants With mCRPC
This FTiH, single-arm, open-label, investigator-initiated Phase I trial will evaluate the safety, antitumour activity, CK/pharmacodynamics (PD), biomarkers, immunogenicity, and feasibility of A-CAR032 in adult participants with mCRPC, who have previously progressed after ARPI treatment of prostate cancer (whether befor
| Condition(s) | Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This FTiH, single-arm, open-label, investigator-initiated Phase I trial will evaluate the safety, antitumour activity, CK/pharmacodynamics (PD), biomarkers, immunogenicity, and feasibility of A-CAR032 in adult participants with mCRPC, who have previously progressed after ARPI treatment of prostate cancer (whether before or in the metastatic castration-resistant setting) and, in the judgment of the investigator, are ineligible for standard treatment. |
| Who can participate | Inclusion Criteria: 1. Participant must be 18 years or older at the time of signing the ICF. Type of Participant and Disease Characteristics 2. Participants with: 1. A histologically confirmed diagnosis of metastatic adenocarcinoma of the prostate without known neuroendocrine differentiation or small cell features. 2. Castration-resistant prostate cancer as defined by disease progression despite castration by orchiectomy or ongoing luteinising hormone-releasing hormone analogue. Participants receiving medical castration therapy with gonadotropin-releasing hormone analogues should continue this treatment during the study. 3. Measurable PSA≥1 ng/mL AND 4. Evidence of progression within 6 months prior to screening 3. Participant has previously received an ARPI (ie, abiraterone, enzalutamide, |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | Shanghai AbelZeta Ltd. |
| Locations | Beijing, Beijing Municipality, China; Beijing, Beijing Municipality, China; Wuhan, Hubei, China; Xuzhou, Jiangsu, China; Hangzhou, Zhejiang, China |
| Start date | 2026-01-13 |
| NCT ID | NCT07344311 |
| Official listing | https://clinicaltrials.gov/study/NCT07344311 |