A Phase 1 Clinical Study to Investigate the Safety, Tolerability and Efficacy of HLX60 (Anti-GARP Monoclonal Antibody) Combination With HLX10 (Anti-PD-1 Monoclonal Antibody) in Subjects With Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- RP2D
研究概览
简要总结
The purpose of the study is to evaluate the safety and tolerability of HLX60 combined with HLX10 in order to determine the maximum tolerated dose (MTD) and Recommended Phase 2 dose (RP2D) and to evaluate the preliminary efficacy for each combination regimen.
详细描述
Accelerated titration and "3 + 3" dose escalation were used in this trial . various doses of HLX60(anti-GARP) combined with HLX10(anti-PD-1) by intravenous infusion.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytologically confirmed advanced malignant solid tumor, who have failed or cannot receive the standard treatment;
- •With at least one evaluable lesion according to RECIST v1.1 (for solid tumors);
- •Patients must be able to supply adequate tumor tissue for biomarker (including the expression of PD-L1, GARP) analyses;
- •Life expectancy longer than three months;
- •Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
排除标准
- •Has a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers, in situ melanoma or in situ cervical cancer. Participants with history of the second malignancy have been disease-free for <3 years.
- •Has a history of (non-infectious) interstitial lung disease (ILD) that required steroids, currently has ILD, or when suspected ILD cannot be ruled out by imaging at screening.
- •Participant has unresolved AEs ≥ Grade 2 from prior anticancer therapy except for alopecia.
- •Those who have received anti-GARP or anti-GARP/TGFβ complex antibody therapy.
结局指标
主要结局
RP2D
时间窗: Through study completion, assessed up to 2 years.
The recommended phase II dose (RP2D) of HLX60 combined with HLX10
Adverse event
时间窗: Through study completion, assessed up to 2 years.
Incidence and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 for patients receiving study drug.
MTD
时间窗: Up to 3 weeks.
The maximum tolerated dose (MTD) of HLX60 combined with HLX10
Incidence of DLT
时间窗: Up to 3 weeks.
Ratio of the number of patients with DLT events in each dose group to the number of patients in the dose group during the DLT evaluation period.
次要结局
- PD(1 year)
- Objective response rate (ORR)(Through study completion, assessed up to 2 years.)
- t1/2(1 year)
- Cmax(1 year)
- AUC(1 year)
- immunogenicity of HLX60(1 year)
- Overall survival(OS)(Through study completion, assessed up to 2 years.)
- Tmax(1 year)
- Progression-free survival (PFS)(Through study completion, assessed up to 2 years.)
- Potential prognostic and predictive biomarkers(1 year)