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

ConditionmCRPC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-75
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Disitamab Vedotin (RC48)

    Drug

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

  • Abiraterone + prednisone

    Drug

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Arm AExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
baseline up to 24 weeks

Secondary outcomes

1

PSA 30

Proportion of patients with a ≥30 % prostate-specific antigen (PSA) reduction from baseline at Week 12, confirmed by a repeat assessment at least 3 weeks later.

Time frame
baseline up to 24 weeks
2

PSA 90

Proportion of patients with a ≥90 % prostate-specific antigen (PSA) reduction from baseline at Week 12, confirmed by a repeat assessment at least 3 weeks later.

Time frame
baseline up to 24 weeks
3

Radiographic Progression-Free Survival（rPFS）

Time from the first day of study drug administration to the earlier of radiographic progression or death from any cause.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Lead sponsor

Nanjing University

Collaborator

Source ClinicalTrials.gov
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