Efficacy and Safety of Disitamab Vedotin Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer：a Phase II Study

NCT07093866 | Recruiting Phase 2 DMC

• 1 other identifier: IUNU-PC-125
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label，prospective，single-arm，phase 2 trial aims to evaluate the efficacy and safety of disitamab vedotin combined with abiraterone in patients with metastatic castration-resistant prostate cancer.

Conditions

mCRPC

Keywords

mCRPC

Outcome Measures

Primary Outcomes (1)

• PSA 50

  Proportion of patients with a ≥50 % prostate-specific antigen (PSA) reduction from baseline at Week 12, confirmed by a repeat assessment at least 3 weeks later.

  baseline up to 24 weeks

Secondary Outcomes (3)

• PSA 30

  baseline up to 24 weeks

• PSA 90

  baseline up to 24 weeks

• Radiographic Progression-Free Survival（rPFS）

  From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months

Study Arms (1)

Arm A

EXPERIMENTAL

mCRPC subjects with IHC 1+/IHC 2+/IHC3+ are administered Disitamab Vedotin combined with Abiraterone

Drug: Disitamab Vedotin (RC48); Drug: Abiraterone + prednisone

Interventions

Disitamab Vedotin (RC48) DRUG

Disitamab Vedotin 2mg/kg is administered intravenously once every 2 weeks (1 cycle)

Arm A

Abiraterone + prednisone DRUG

Abiraterone 1000mg is administered orally once a day，and prednisone 5mg is administered orally twice a day.

Arm A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are able to understand and voluntarily sign the informed consent form (ICF); judged by the investigator to be capable of complying with the protocol.
• Male patients of ≥18 years or older at the time of ICF signature.
• Patients with ECOG performance status 0-1.
• Patients with an expected survival of 3months or more.
• Patients who are histologically or cytologically confirmed prostatic adenocarcinoma with HER2 expression (IHC 1+, 2+ or 3+) in archival or fresh tumour tissue.
• Patients with documented castration-resistant prostate cancer (CRPC): serum testosterone \<1.73 nmol/L (50 ng/dL) at screening; patients on medical castration must continue LHRH agonist/antagonist therapy throughout the study.
• Patients with evidence of metastatic disease by bone scan (bone lesions) and/or CT/MRI (soft-tissue lesions).
• Patients with adequate organ function as defined below:
• Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L
• Platelet count (PLT) ≥100 × 10⁹/L
• Hemoglobin (Hb) ≥100 g/L
• Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); ≤2 × ULN if liver metastases present
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN; ≤2 × ULN if liver metastases present
• Serum creatinine (Cr) ≤1.5 × ULN or calculated creatinine clearance (CrCl) ≥60 mL/min (Cockcroft-Gault formula; calculate only if Cr \>1.5 × ULN)
• Urinalysis protein \<2+; if ≥2+, 24-h urine protein must be \<1 g or urine protein/creatinine ratio \<0.5

You may not qualify if:

• Patients who are known hypersensitivity to any component of disitamab vedotin or abiraterone.
• Patients with other malignancies within 3 years before screening, except early-stage malignancies considered clinically cured (carcinoma in situ or stage I tumors), e.g., basal-cell or squamous-cell skin carcinoma or superficial bladder cancer.
• Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with treated brain metastases may enroll if lesions have been stable for ≥1 month, there is no evidence of new or enlarging CNS disease, and systemic corticosteroids have been discontinued ≥3 days before the first study dose.
• Patients who are clinically significant pericardial effusion, or pleural/peritoneal/pelvic effusions that are poorly controlled or require drainage within 2 weeks before the first dose.
• Patients with major surgical intervention (any grade 3 or 4 procedure per the 2009 Chinese Regulation on Clinical Application of Medical Technologies) within 4 weeks before the first dose, or incomplete post-operative recovery that, in the investigator's judgment, poses a risk to trial participation.
• Patients who are prior PSMA-targeted therapy.
• Patients within 4 weeks (6 weeks for nitrosoureas or mitomycin C) before the first dose: any antineoplastic chemotherapy (except castration therapy), radiotherapy (\>1 week of local palliative radiotherapy permitted), endocrine therapy (estrogens or anti-androgens; bicalutamide or nilutamide require 6-week washout), targeted therapy, immunotherapy, or participation in another interventional clinical trial (observational studies or post-trial follow-up are allowed).
• Patients with stable-dose denosumab or bisphosphonates for bone metastases are permitted.
• mCRPC patients must not have used PSA-lowering herbal agents (e.g., saw palmetto) or systemic corticosteroids (except short courses for allergy prophylaxis/treatment) within 4 weeks before the first dose, nor plan to use such agents during the study.
• Patients with use of antineoplastic traditional Chinese medicine (TCM) prescriptions or proprietary TCM within 1 week, or receipt of blood transfusion/blood products, hematopoietic growth factors, or other agents to correct blood cell counts within 2 weeks before first study dose.
• Patients with unexplained fever \>38.5 °C (tumor-related fever may be allowed per investigator judgment); active or persistent infection; HIV antibody positive; HBsAg positive with HBV DNA \> site ULN, or HBsAg-negative/HBcAb-positive with HBV DNA \> site ULN after treatment; HCV antibody positive with HCV RNA \> site ULN; active syphilis (except adequately treated, cured, or stable syphilis).
• NYHA class III/IV congestive heart failure; uncontrolled arrhythmia despite treatment/intervention; risk of QT prolongation or use of drugs known to prolong QT; refractory hypertension (hypertension controlled to \<140/90 mmHg on medication is allowed).
• Patients with clinically significant vascular events within 6 months before first dose, including acute arterial/venous thromboembolism, thrombotic arteritis, thrombophlebitis, acute pulmonary embolism, acute coronary syndrome (MI, unstable angina, etc.), acute cerebrovascular events, or disseminated intravascular coagulation.
• Patients with tumor metastases with clear invasion of major arteries posing a high bleeding risk.
• Patients with interstitial pneumonitis, pulmonary fibrosis, or other severe pulmonary disease requiring treatment; hemoptysis \>2.5 mL per episode within 3 weeks before first dose.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead
• Nanjing University: collaborator

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu 210000

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Interventions

disitamab vedotin; RC48 antibody; abiraterone; Prednisone

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Hongqian Guo Hong qian Guo

CONTACT

8613605171690; gymwpi@126.com

Shun Zhang Shun Zhang

CONTACT

8615050589789; gymwgcp@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Model Details: Experimental regimen: Disitamab vedotin +Abiraterone +Prednisone

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start: July 20, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)