NCT06389526尚未招募1 期
A Phase 1, Multicenter, Open-Label Study of CHS-1000 as a Single Agent and in Combination With Toripalimab-tpzi in Participants With Advanced or Metastatic Solid Tumors
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
- 入组人数
- 48
- 主要终点
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The primary purpose of this trial is to assess the tolerability and safety of CHS-1000 alone and in combination with toripalimab-tpzi in participants with advanced solid tumors.
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
- •Histopathologically or cytologically confirmed diagnosis of advanced or metastatic unresectable solid tumors (excluding glioblastoma multiforme (GBM)) by tissue biopsy or archival tumor specimen. Unresectable tumors are defined as tumors with lesions in which clear surgical excision margins cannot be obtained, in close proximity to major blood vessels, not with oligometastatic and with advanced organ and lymph node (LN) involvement, and not leading to significant functional compromise as determined by surgical consult or Tumor Board.
- •Participants must have been previously treated or be ineligible for, or intolerant of, available approved standard therapies known to confer clinical benefit (including immunotherapy), or for whom no effective standard therapy exists.
- •At least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the investigator.
排除标准
- •Concurrent enrollment in another clinical study or participation in another clinical study within 28 days prior to the 1st dose of CHS-1000, except for observational (noninterventional) studies or the follow-up period of an interventional study.
- •Current or prior use of systemic anticancer treatment, including but not limited to chemotherapy, immunotherapy, biologic treatment, hormone therapy, and targeted therapy, if within 8 weeks or 5 half-lives (whichever is shorter) for biologic therapies, or if within 28 days for most other anticancer therapies, prior to the 1st dose of CHS-
- •Concurrent or prior radiotherapy within 28 days prior to the 1st dose of CHS-1000 or unresolved treatment-related radiation toxicity. Limited local radiotherapy for palliative intent (eg, to a single site of metastatic disease) is permitted within 28 days prior to the 1st dose of CHS-1000 provided that the participant has no evidence of or has recovered from any treatment-related radiation toxicity.
- •Note: Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Part A: Single Agent CHS-1000
Experimental
干预措施: CHS-1000 (Biological)
Part B: Combination Agents CHS-1000 + Toripalimab
Experimental
干预措施: CHS-1000 (Biological)
Part B: Combination Agents CHS-1000 + Toripalimab
Experimental
干预措施: Toripalimab (Biological)
结局指标
主要结局
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to approximately 27 months
次要结局
- Time to Response (TTP)(Up to approximately 27 months)
- Area Under the Concentration-time Curve (AUC)(Up to approximately 27 months)
- Terminal Half-life (t1/2)(Up to approximately 27 months)
- Maximum Observed Concentration (Cmax)(Up to approximately 27 months)
- Investigator-assessed Objective Response Rate (ORR)(Up to approximately 27 months)
- Duration of Response (DoR)(Up to approximately 27 months)
- Disease Control Rate (DCR)(Up to approximately 27 months)
- Number of Participants with Antidrug Antibodies(Up to approximately 27 months)
- Landmark PFS Rate(Month 6, Month 12)
- Progression-free Survival (PFS)(Up to approximately 27 months)
研究者
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