NCT07093866招募中2 期
Efficacy and Safety of Disitamab Vedotin Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer：a Phase II Study
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年7月20日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- PSA 50
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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-
- •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
- •For patients not on anticoagulation: INR and aPTT ≤1.5 × ULN; patients on stable-dose anticoagulation are eligible
- •Left ventricular ejection fraction (LVEF) ≥50% or ≥local lower limit of normal (LLN), whichever is lower
- •QTcF interval <470 ms
- •Male patients with partners of child-bearing potential must use a medically acceptable contraceptive method from the first study dose until 3 months after the last dose.
排除标准
- •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 toxicities from prior antineoplastic therapy that have not resolved to baseline, CTCAE v5.0 grade 0-1 (except alopecia and pigmentation), or to the levels specified in the inclusion/exclusion criteria; unhealed wounds. Irreversible toxicities not expected to worsen with study drug (e.g., hearing loss) are permitted.
- •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.
- •Patients with active gastro-intestinal ulcer, perforation, and/or fistula requiring treatment within 6 months; GI bleeding (hematemesis, melena, or hematochezia) within 3 months without endoscopic/colonoscopic evidence of complete healing.
- •Patients with uncontrolled concurrent disease >CTCAE v5.0 grade 2 (e.g., diabetes).
- •Uncontrolled concurrent disease >CTCAE v5.0 grade 2 (e.g., diabetes).
- •Patients with CTCAE v5.0 grade >2 peripheral neuropathy, prior epilepsy, psychiatric disorders; history of drug abuse within 6 months or alcohol abuse within 3 months (alcohol abuse defined as >14 units/week: 1 unit = 285 mL beer, 25 mL spirits, or 80 mL wine).
- •Patients with autoimmune disease, immunodeficiency, or organ transplantation.
- •Patients with any condition, therapy, or laboratory abnormality that, in the investigator's opinion, could confound results, interfere with trial participation, or be not in the subject's best interest.
研究组 & 干预措施
Arm A
Experimental
mCRPC subjects with IHC 1+/IHC 2+/IHC3+ are administered Disitamab Vedotin combined with Abiraterone
干预措施: Disitamab Vedotin (RC48) (Drug)
Arm A
Experimental
mCRPC subjects with IHC 1+/IHC 2+/IHC3+ are administered Disitamab Vedotin combined with Abiraterone
干预措施: Abiraterone + prednisone (Drug)
结局指标
主要结局
PSA 50
时间窗: baseline up to 24 weeks
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.
次要结局
- 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)
研究者
Hongqian Guo
Chief physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
研究点 (1)
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