NCT07834359尚未招募1 期
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20197 in Participants With Advanced Solid Tumors
Hansoh BioMedical R&D Company1 个研究点 分布在 1 个国家目标入组 595 人开始时间: 2026年10月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 595
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) or maximum applicable dose (MAD)
研究概览
简要总结
This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20197 in participants with advanced solid malignant tumors.
详细描述
This is a multicenter, open-label, Phase I study evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of intravenously administered HS-20197 in participants with advanced solid tumors. The study comprises a Phase Ia dose-escalation phase followed by a Phase Ib dose-expansion phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, aged ≥ 18 years.
- •Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors.
- •Participants have at least 1 target lesion other than CNS lesions according to RECIST 1.
排除标准
- •Participants have received or are receiving the following treatment:
- •Anti-tumor drugs within 14 days prior to the first dose of study treatment; any other IMPs or macromolecular anti-tumor drugs within 28 days prior to the first dose of study treatment.
- •Local radiotherapy within 2 weeks prior to the first dose of study treatment; irradiation of more than 30% of bone marrow or extensive radiotherapy within 4 weeks prior to the first dose of study treatment.
- •Major surgery within 4 weeks prior to the first dose of study treatment.
- •Participants previously treated with drugs that are moderate to strong inhibitors or moderate to strong inducers of cytochrome P450 (CYP) 3A4, strong inhibitors or strong inducers of CYP2D6, P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) or drugs with a narrow therapeutic range that are sensitive substrates of P-gp or BCRP within 7 days prior to the first dose of the IMP. Participants who need to receive these drugs during the study period should also be excluded.
- •Current use of drugs known to prolong the QT interval or that may cause torsade de pointes. Participants who need to receive these drugs during the study period should also be excluded.
- •Live vaccine or live-attenuated vaccine within 28 weeks prior to the first dose.
- •Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 6.0) from prior therapies (except alopecia and residual neurotoxicity).
- •Participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins.
- •Participants who are allergic to any component of HS-20197.
研究组 & 干预措施
Phase Ia：Dose escalation
Experimental
干预措施: HS-20197 (Drug)
Phase 1b Dose expansion
Experimental
干预措施: HS-20197 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) or maximum applicable dose (MAD)
时间窗: From Day 1 to 21 days after first dose
RDE will be determined using DLTs and number of participants with treatment-related adverse events as assessed by CTCAE v6.0 and preliminary clinical efficacy
Recommended dose for expansion (RDE) of HS-20197 monotherapy
时间窗: From Day 1 to 90 days after last dose
To comprehensively evaluate the safety, pharmacokinetic profile, and preliminary clinical efficacy to determine the recommended dose for expansion (RDE).
次要结局
- Objective response rate (ORR)(From screening to up to 3 years after last dose)
- Disease control rate (DCR)(From screening to up to 3 years after last dose)
- Duration of response (DoR)(From screening to up to 3 years after last dose)
- Progression-free survival (PFS)(From screening to up to 3 years after last dose)
- Overall survival (OS)(From screening to up to 3 years after last dose)
- Maximum observed concentration (C[max])(From the first dose until 90 days after the last dose)
- Time to maximum concentration (Tmax)(From the first dose until 90 days after the last dose)
- Area under the curve (AUC)(From the first dose until 90 days after the last dose)
- Terminal half-life (t1/2)(From the first dose until 90 days after the last dose)
- Concentration of anti-drug antibodies (ADAs)(From the first dose until 90 days after the last dose)
研究者
研究点 (1)
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