A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 285
- 试验地点
- 11
- 主要终点
- All Phases: Adverse events (AEs)
研究概览
简要总结
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.
详细描述
This study consists of Phase 1a dose escalation, Phase 1b dose expansion in a single indication, and Phase 2a expansion in a single indication.
Primary Objectives
- All Phases: Evaluate the safety and tolerability of MDX2001 in patients with advanced solid tumor malignancies
- Phase 1 only: Identify a recommended Phase 2 dose (RP2D) for further development of MDX2001
- For Phase 1b and Phase 2: Assess the anti-tumor efficacy of MDX2001 in patients with selected advanced solid tumor malignancies
Secondary Objectives:
- Further characterize the anti-tumor activity of MDX2001 based on additional assessments of clinical benefit
- Characterize the pharmacokinetics of MDX2001
- Characterize the immunogenicity of MDX2001
- Characterize relationship of baseline target protein expression in tumor tissue and clinical benefit
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Patients must be ≥ 18 years of age
- •Histologically or cytologically confirmed diagnosis of metastatic solid tumors
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •All patients should have at least 1 measurable disease per RECIST v1.
- •An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion.
- •All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Adequate hematologic, hepatic and renal function
- •Capable of giving signed informed consent
排除标准
- •Any clinically significant cardiac disease
- •Unresolved toxicities from previous anticancer therapy
- •Prior solid organ or hematologic transplant
- •Known untreated, active, or uncontrolled brain metastases
- •Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infectiion requiring intravenous treatment.
- •Receipt of a live-virus vaccination within 28 days of planned treatment start
- •Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.
- •Participation in a concurrent clinical study in the treatment period.
- •Known hypersensitivity to MDX2001 or any of its ingredients
- •Supplemental oxygen use for activities of daily living
- •The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
研究组 & 干预措施
Phase 1b - Indication Optimization
Patients with a single tumor indication receive MDX2001 as intravenous (IV) infusion.
干预措施: MDX2001 (Drug)
Phase 1a - MDX2001 Dose Escalation
Patients with metastatic solid tumors will receive MDX2001 as intravenous (IV) infusion.
干预措施: MDX2001 (Drug)
Phase 2a - Cohort Expansion
Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion at the recommended Phase 2 dose.
干预措施: MDX2001 (Drug)
Phase 1b - Dose Optimization
Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion.
干预措施: MDX2001 (Drug)
结局指标
主要结局
All Phases: Adverse events (AEs)
时间窗: Baseline until end of study, up to approximately 9 months
Incidence and severity of AEs and serious AEs (SAEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 including changes in clinical laboratory parameters
Phase 1b and Phase 2a: Objective response rate of MDX2001
时间窗: From date of enrollment until the end of treatment, up to approximately 6 months
Objective response rate is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Phase 1: Recommended Phase 2 dose (RP2D)
时间窗: Baseline until end of study, up to approximately 9 months
Recommended Phase 2 dose is determined following the evaluation of MDX2001 safety including the incidences of dose limiting toxicities (DLTs), MDX2001 anti-tumor activity, and MDX2001 pharmacokinetics
次要结局
- All Phases: Time to response (TTR)(From date of enrollment until the first documentation of response (CR or PR), approximately 4 months)
- All Phases: Disease control rate (DCR)(From date of enrollment until the end of treatment, up to approximately 6 months)
- All Phases: Pharmacokinetic Parameter Cmax of MDX2001(From date of enrollment until completion of the 6th cycle of treatment, up to approximately 6 months)
- All Phases: Pharmacokinetic parameter area under the curve (AUC(0-T)) of MDX2001(From date of enrollment until the completion of the 3rd cycle of treatment, up to approximately 3 months)
- All Phases: Evaluation of MDX2001 immunogenicity(Baseline until end of study, up to approximately 9 months)
- All Phases: Correlation between tumor antigen expression and anti-tumor activity of MDX2001(Baseline until the end of treatment, up to approximately 6 months)
- Phase 1a: Objective response rate of MDX2001(From date of enrollment until the end of treatment, up to approximately 6 months)
- All Phases: Duration of response (DOR)(From date of enrollment until the end of treatment, up to approximately 6 months)
- All Phases: Progression free survival (PFS)(From date of enrollment until the end of treatment, up to approximately 6 months)