A First-in-Human, Phase 1 Dose Escalation and Dose Expansion Trial to Assess the Safety and Tolerability of COM503 as Monotherapy and in Combination Therapy in Participants With Advanced Solid Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Compugen Ltd
- 入组人数
- 200
- 试验地点
- 18
- 主要终点
- To evaluate the safety profile of COM503 in combination with zimberelimab in participants with advanced malignancies
研究概览
简要总结
The overall goal of this first-in-human (FIH) clinical trial is to learn about the safety and dosing of COM503 when given alone or in combination with zimberelimab in participants with advanced solid tumors.
The primary objectives of this study are:
- To assess the safety and tolerability of COM503 as monotherapy and COM503 in combination with zimberelimab in participants with advanced solid tumors.
- To identify the maximum tolerated dose (MTD) / maximum administered dose (MAD) and/or the recommended phase 2 dose (RP2D) of COM503 as monotherapy and in combination with zimberelimab 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
- •Participants with histologically/cytologically confirmed advanced recurrent or metastatic solid tumor malignancy
- •Part 1 (dose escalation): Participants must have had disease progression on or following all available standard of care (SOC) therapies known to confer clinical benefit.
- •Part 2 (dose expansion): Participants may be enrolled following disease progression that has progressed after at least 1 available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized SOC.
- •Participants must have a solid tumor measurable by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria by investigator assessment
排除标准
- •History of another malignancy within 2 years prior to the first trial intervention administration (unless the malignancy was treated with curative intent with low risk of recurrence [e.g., nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar] which are allowed to enroll).
- •Therapy with Immunosuppressive doses of systemic medications, such as steroids (doses >10 mg/day prednisone or equivalent daily) within 2 weeks before trial intervention administration
- •Have known active central nervous system (CNS) metastases and/or leptomeningeal disease (LMD).
- •Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively.
- •Ascites or pleural effusion that is symptomatic and/or requiring drainage within 2 weeks prior to the first trial intervention administration.
- •Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or participants with human immunodeficiency virus (HIV).
- •Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the participant's participation in the trial.
研究组 & 干预措施
Part 1, A-2
Backfill
干预措施: COM503 (Drug)
Part 1, B
Dose escalation, COM503 in combination with a fixed dose of zimberelimab.
干预措施: COM503 (Drug)
Part 2, A
Dose expansion, COM503 monotherapy
干预措施: COM503 (Drug)
Part 2, B
Dose expansion, COM503 in combination with a fixed dose of zimberelimab.
干预措施: COM503 (Drug)
Part 1, A-1
Monotherapy Dose Escalation
干预措施: COM503 (Drug)
Part 1, B
Dose escalation, COM503 in combination with a fixed dose of zimberelimab.
干预措施: Zimberelimab (Drug)
Part 2, B
Dose expansion, COM503 in combination with a fixed dose of zimberelimab.
干预措施: Zimberelimab (Drug)
结局指标
主要结局
To evaluate the safety profile of COM503 in combination with zimberelimab in participants with advanced malignancies
时间窗: from the first dose of COM503 to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy.
Number of participants in combination cohorts with treatment-related serious adverse events as assessed by CTCAE v4.
To evaluate the safety profile of COM503 as monotherapy in participants with advanced malignancies.
时间窗: from the first dose of COM503 to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy.
Number of participants in monotherapy cohorts with treatment-related adverse events as assessed by CTCAE v4.0
To evaluate the safety profile of COM503 in combination with zimberelimab in participants with advanced malignancies
时间窗: from the first dose of COM503 in combination with zimberelimab to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy.
Number of participants in combination cohorts with treatment-related adverse events as assessed by CTCAE v4.
次要结局
未报告次要终点