A Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL242 Monotherapy and Combinations in Advanced Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 424
- 试验地点
- 15
- 主要终点
- Objective Response Rate (ORR) in Participants With Advanced Solid Malignant Tumors (Part 2, and 4-6)
研究概览
简要总结
This is a multicenter, open-label study to evaluate the safety and tolerability of YL242 monotherapy and combination in participants with advanced solid malignant 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
- •Aged ≥18 years.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- •Adequate organ and bone marrow function
- •Tumor type:
- •Part 1-3: Advanced/unresectable or metastatic solid malignant tumor; Have received at least one prior line of systemic anti-tumor therapy
- •Part 4: locally advanced or metastatic non-sq NSCLC without AGA and HCC; Have not received any systemic anti-tumor therapy;
- •Part 5: mCRC, have received at least one (5a) or one (5b) prior line of systemic anti-tumor therapy
- •Part 6: advanced or metastatic HER2-negative G/GEJ; have received at least one (6a) or one (6b) prior line of systemic anti-tumor therapy
排除标准
- •Be intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor
- •Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases
- •Clinically significant concomitant pulmonary disease
- •A history of leptomeningeal carcinomatosis or carcinomatous meningitis
- •Any illness, medical condition, organ system dysfunction, or social situation, including but not limited to mental illness or substance/alcohol abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results
研究组 & 干预措施
Part 1 and Part 2: Mono Dose Escalation & Expansion
Participants receive YL242 administered via intravenous (IV) solution per protocol defined dose level and frequency.
干预措施: YL242 (Drug)
Part 3 and 4: Combination Dose Escalation & Expansion
Participants receive YL242 at protocol defined dose level, in combination with Pembrolizumab (200 mg), administered via intravenous (IV) solution at protocol defined dose level and frequency.
干预措施: YL242; Pembrolizumab (Drug)
Part 5: Combination Dose Optimization and Expansion
Participants receive YL242, 5-FU and LV, administered via intravenous (IV) solution.
干预措施: YL242; 5-FU; LV (Drug)
Part 6: Combination Dose Optimization and Expansion
Participants receive YL242, pembrolizumab and 5-FU, administered via intravenous (IV) solution at protocol defined frequency.
干预措施: YL242; Pembrolizumab; 5-FU (Drug)
结局指标
主要结局
Objective Response Rate (ORR) in Participants With Advanced Solid Malignant Tumors (Part 2, and 4-6)
时间窗: Approximately within 36 months
Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response \[CR\] or partial response \[PR\] per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)
时间窗: Baseline up to 42 days post last patients last dose, approximately within 36 months
AEs will be collected systematically from signing of the informed consent form (ICF) through 42 days after last dose.
次要结局
- Area Under the Serum Concentration Time Curve (AUC) of YL242(Approximately within 36 months)
- Maximum Plasma Concentration (Cmax) of YL242(Approximately within 36 months)
- Time to Maximum Plasma Concentration (Tmax) of YL242(Approximately within 36 months)
- Incidence of anti-YL242 antibody(Approximately within 36 months)
- Terminal Elimination Half-life (t1/2) of Serum YL242(Approximately within 36 months)
- Disease Control Rate (DCR)(Approximately within 36 months)