An Open-label, Phase 1a/b, Multicenter Study of ZL-6201 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Participants With Sarcoma and Selected Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 8
- 主要终点
- Incidence of Dose Limiting Toxicities
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of investigational study drug ZL-6201 for treating sarcoma and solid tumors cancer.
详细描述
An Open-label, Phase 1a/b, Multicenter Study of ZL-6201 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Participants with Sarcoma and Selected Solid Tumors
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult men and women ≥18 years of age at the time of signing the ICF with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy > 3 months
- •Participants must have histologically confirmed and documented diagnosis of locally advanced unresectable and/or metastatic sarcoma or a selected solid tumor
- •Participants must be willing to undergo a tumor biopsy prior to start of treatment or provide archived tumor tissue sample
- •Participants with sarcoma should have received no more than 2 lines of previous systemic therapies in the metastatic setting
- •Participants with selected epithelial solid tumors should have received no more than 3 lines of previous systemic therapy in the metastatic/relapsed refractory setting
- •Participants must have at least one measurable target lesion as defined by RECIST v1.1
- •Adequate organ and marrow function as listed per protocol
- •Must be negative for HIV, HBV, and HCV
排除标准
- •Participants with another known malignancy that has required treatment within the last 2 years
- •Symptomatic central nervous system (CNS) metastasis, and/or those requiring therapy with corticosteroids or anticonvulsants to control associated symptoms
- •Participants with leptomeningeal metastasis
- •Most recent systemic anti-cancer treatment or investigational products/devices less than 3 weeks
- •Prior treatment with a topoisomerase-1 inhibitor antibody drug conjugate
- •Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment
- •Clinically significant pulmonary disease including autoimmune, connective tissue, or inflammatory conditions
- •Pregnant or nursing (lactating) women
研究组 & 干预措施
ZL-6201
ZL-6201 as a single agent
干预措施: ZL-6201 (Drug)
结局指标
主要结局
Incidence of Dose Limiting Toxicities
时间窗: 1 cycle of study treatment (each cycle is 21 days)
Number of subjects with dose limiting toxicities (DLTs) through dose escalation only.
Incidence of Treatment Emergent Adverse Events
时间窗: 36 months
Number of subjects with treatment-emergent adverse effects through dose escalation and expansion.
Incidence of Serious adverse events
时间窗: 36 months
Number of subjects with Serious Adverse Events through dose escalation and expansion.
Number of participants with clinical laboratory abnormalities
时间窗: 36 months
Number of participants with vital sign abnormalities
时间窗: 36 months
Vitals will be measured in Riva Rocci (RR) in mmHG and Pulse in beats per minute
Number of participants with electrocardiogram (ECG) abnormalities
时间窗: 36 months
ECG will be measured in ECG intervals (QT and QTc with Fridericia correction, and PR), QRS duration, and heart rate will be tested and analyzed.
次要结局
- ORR per RECIST 1.1(36 months)
- Duration of Response per RECIST 1.1(36 months)
- PFS per RECIST 1.1(36 months)
- DCR per RECIST 1.1(36 months)
- PK characteristics of ZL-6201 (ADC conjugate), total antibody(36 months)
- PK characteristics of ZL-6201 (ADC conjugate), unconjugated payloads(36 month)