NCT05162755已完成1 期
A Phase 1a/1b, Open-label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Anti-neoplastic Activity of S095029 (Anti-NKG2A) as Monotherapy and in Combination With Sym021 (Anti-PD-1) in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triplet Combinations of S095029 and Sym021 and an Anti-HER2 mAb or Anti-EGFR mAbs (Futuximab/Modotuximab) in Patients With Metastatic Gastric or Colorectal Cancers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 9
- 主要终点
- Adverse Events (AEs) (Dose escalation part)
研究概览
简要总结
The purpose of the study is to investigate the safety, tolerability, and preliminary anti-neoplastic activity of S095029 alone and in combination with Sym021 in patients with advanced solid tumor malignancies followed by an expansion phase of triple combinations.
*The study sponsor has made the decision not to move forward to the expansion part of the study due to strategic considerations, unrelated to any safety issues or concerns. The study will be stopped after completion of dose escalation parts 1a and 1b of the study.
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
- •Dose escalation part:
- •Inclusion Criteria:
- •Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumor malignancies
- •Patients with a malignancy not amenable to surgical intervention
- •Patients with measurable disease and progression radiologically assessed
- •Patients with disease progression after treatment with available standard of care therapies that are known to confer clinical benefit or who are intolerant to treatment.
- •Patients with available archived tumor biopsy specimens or agree to mandatory biopsy
- •Estimated life expectancy ≥ 12 weeks
- •Adequate haematological function
- •Adequate renal function
- •Adequate hepatic function
排除标准
- •Pregnant and lactating women
- •Major surgery within 4 weeks prior to the first IMP administration or not recovered from the surgery
- •Patients with serious/active/uncontrolled infection or infection requiring parenteral antibiotics, within 2 weeks prior to first IMP administration
- •Active Hepatitis B Virus infection
- •Carriers of HIV antibodies
- •Patients with active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to first IMP administration
- •History of organ transplantation
- •History of gastrointestinal perforation, or intra-abdominal abscess within 28 days of inclusion
- •History of cirrhosis
- •History of pulmonary fibrosis or relevant uncontrolled chronic pulmonary condition
- •Treatment with systemic immunosuppressive therapy
- •Active autoimmune disease
- •Administration of a live vaccine within 28 days prior to inclusion
研究组 & 干预措施
Dose escalation 1b: S95029 and Sym021
Experimental
干预措施: S95029 and Sym021 (Drug)
Dose escalation 1a: S95029
Experimental
干预措施: S095029 (Drug)
结局指标
主要结局
Adverse Events (AEs) (Dose escalation part)
时间窗: Through study completion, up to 2 years
Incidence, severity, and relationship of AEs
Incidence of dose limiting toxicities (DLTs) (Dose escalation part)
时间窗: At the end of Cycle 1 (each cycle is 28 days)
DLTs observed during a 28-day period
次要结局
- Objective Response Rate(Through study completion, up to 2 years)
- Clinical Benefit Rate (CBR)(Through study completion, up to 2 years)
- Duration of response (DOR)(Through study completion, up to 2 years)
- Progression Free Survival (PFS)(Through study completion, up to 2 years)
- Overall Survival (OS)(Through study completion, up to 2 years)
研究者
研究点 (9)
Loading locations...
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