NCT07115446招募中1 期
A Phase Ib Study to Explore the Safety, Tolerability, and Pharmacokinetics of HS-20093 Combination With HRS-5041 in Patients With Advanced Prostate Cancer
Hansoh BioMedical R&D Company1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2025年8月19日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- To determine the maximum tolerated dose (MTD) or Maximum Administrated dose (MAD)
研究概览
简要总结
HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. HRS-5041 is a Proteolysis Targeting Chimeras (PROTAC) targeting androgen receptors.
This is a phase Ib, open-label, multi-center study to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-20093 combination with HRS-5041 in patients with advanced 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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men greater than or equal to 18 years.
- •Voluntarily to participate, Signed and dated Informed Consent Form.
- •Patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed after at least one type of novel hormonal therapy (standard treatment).
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~
- •Estimated life expectancy ≥ 12 weeks.
- •Men should use adequate contraceptive measures throughout the study, up to 3 months after the last dose of HRS-5041 or 4.5 months after the last dose of HS-20093 (whichever is later).
排除标准
- •Treatment with any of the following:
- •a. Previous or current treatment with B7-H3 targeted therapy. b. Previous treatment with AR PROTAC. c. Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 21 days prior to the first scheduled dose of HS-20093+HRS-
- •d. brain metastases.
- •Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.
- •History of other primary malignancies.
- •Inadequate bone marrow reserve or organ dysfunction.
- •Severe, uncontrolled or active cardiovascular diseases.
- •Severe or uncontrolled diabetes.
- •The presence of active infectious diseases.
- •Any known or suspected interstitial lung disease.
- •History of serious neuropathy or mental disorders.
- •History of severe hypersensitivity reaction, severe infusion reaction.
- •Hypersensitivity to any ingredient of HS-
- •Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.
- •Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.
研究组 & 干预措施
HS-20093+HRS-5041
Experimental
Participants will receive HS-20093 at RP2D and HRS-5041 at Dose1 or Dose2.
干预措施: HS-20093 (Drug)
HS-20093+HRS-5041
Experimental
Participants will receive HS-20093 at RP2D and HRS-5041 at Dose1 or Dose2.
干预措施: HRS-5041 (Drug)
结局指标
主要结局
To determine the maximum tolerated dose (MTD) or Maximum Administrated dose (MAD)
时间窗: 21 days from administration of the first dose (C1D1) in the dose escalation phase， assessed up to 24 months
Number of participants with dose limiting toxicity
次要结局
- To evaluate the Duration of response (DoR) determined by investigators according to RECIST 1.1 and PCWG3(up to approximately 24 months)
- To evaluate the incidence and severity of adverse events (AEs)(From the first dose(C1D1) up to 30 days after the last dose of HRS-5041 or 90 days after the last dose of HS-20093 (whichever is later))
- To evaluate the maximum plasma concentration (Cmax)(up to approximately 24 months)
- To evaluate the Time to reach maximum plasma concentration (Tmax)(up to approximately 24 months)
- To evaluate the Area under plasma concentration versus time curve from zero to last sampling time (AUC)(up to approximately 24 months)
- To evaluate the ORR determined by investigators(up to approximately 24 months)
- To evaluate the immunogenicity of HS-20093(up to approximately 24 months)
- To evaluate the Prostate-specific Cancer Antigen (PSA) response rate（PSA30,PSA50,PSA90）(up to approximately 24 months)
- To evaluate the Disease control rate (DCR) determined by investigators according to RECIST 1.1 and PCWG3(up to approximately 24 months)
- To evaluate the Time to PSA progression(up to approximately 24 months)
研究者
研究点 (1)
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