A Phase 1/2, Multi-Center, Open-Label Clinical Study Evaluating MDX2004 In Participants With Advanced Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 235
- 试验地点
- 7
- 主要终点
- Part B, C, and D: Objective response rate of MDX2004
研究概览
简要总结
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2004 in patients with advanced 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
- •Participant must be ≥ 18 years of age.
- •Histologically or cytologically confirmed diagnosis of locally advanced or metastatic malignancy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •All participants should have at least 1 measurable site of disease according to RECIST v1.
- •An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion.
- •Adequate hematologic, hepatic and renal function.
- •All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Capable of giving signed informed consent.
排除标准
- •Any clinically significant cardiac disease.
- •Unresolved toxicities from previous anticancer therapy.
- •Known untreated, active, or uncontrolled brain metastases.
- •Previous Grade 3 or 4 immune-related toxicity that led to the discontinuation of treatment, within 6 months prior to the first dose of MDX
- •Active medical condition requiring chronic systemic steroid use (>10 mg/day prednisone or equivalent) or immunosuppressive therapy, within 6 months prior to the first dose of MDX
- •Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infection requiring intravenous treatment.
- •Prior solid organ or hematologic transplant
- •Require supplemental oxygen for activities of daily living
- •Participant is not suitable for participation, whatever the reason, as judged by the Investigator including medical or clinical conditions.
研究组 & 干预措施
Dose Escalation - Part A
Participants with advanced tumors will receive MDX2004 as intravenous (IV) infusion.
干预措施: MDX2004 (Drug)
Indication Optimization - Part B
Participants with select advanced tumors will receive MDX2004 as intravenous (IV) infusion.
干预措施: MDX2004 (Drug)
Dose Optimization - Part C
Participants with select advanced tumors will receive one of two recommended doses of MDX2004 as intravenous (IV) infusion.
干预措施: MDX2004 (Drug)
Dose Expansion - Part D
Participants with select advanced tumors will receive the recommended Phase 2 dose of MDX2004 as intravenous (IV) infusion.
干预措施: MDX2004 (Drug)
结局指标
主要结局
Part B, C, and D: Objective response rate of MDX2004
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.
All Study Parts: Adverse Events (AEs)
时间窗: Baseline until 90 days after the participant has the last dose of MDX2004
Incidence and severity of adverse events (AEs) and serious AEs (SAEs), including changes in clinical laboratory parameters, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria, including changes in clinical laboratory parameters
Part A only - Maximum Tolerated Dose (MTD) or Recommended Phase 2 dose (RP2D)
时间窗: 28 days
Maximum Tolerated Dose or Recommended Phase 2 dose is determined following the evaluation of MDX2004 safety including the incidences of dose limiting toxicities (DLTs), MDX2004 anti-tumor activity, and MDX2004 pharmacokinetics/pharmacodynamics.
次要结局
- All Study Parts: Measure of maximum serum concentration (Cmax) of MDX2004(6 months)
- All Study Parts: Measure of volume of distribution (Vd) of MDX2004(6 months)
- All Study Parts: Measure of system clearance of MDX2004(6 months)
- All Study Parts: Evaluation of MDX2004 immunogenicity(6 months)
- All Study Parts: Disease Control Rate (DCR)(From date of enrollment until the end of treatment, up to approximately 6 months)
- All Study Parts: Measure of terminal half-life (t1/2) of MDX2004(6 months)
- All Study Parts: Measure of time to maximum concentration (Tmax) of MDX2004(6 months)
- All Study Parts: Measure of area under the serum concentration-time curve (AUC) of MDX2004(6 months)
- All Study Parts: Pharmacodynamic characterization of MDX2004(6 months)
- All Study Parts: Duration of Response (DoR)(From date of enrollment until the end of treatment, up to approximately 6 months)
- All Study Parts: Time to Response(From date of enrollment until the end of treatment, up to approximately 6 months)
- All Study Parts: Progression Free Survival (PFS)(From date of enrollment until the end of treatment, up to approximately 6 months)