NCT06885281招募中1 期
A Phase 1b/2, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 166
- 试验地点
- 53
- 主要终点
- Incidence of Treatment Emergent Adverse-Events in Phase 1b
研究概览
简要总结
A Phase 1b/2, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors
详细描述
This is an open-label, multiple-center, phase 1b/2 study of ZL-1310 in selected solid tumors. ZL-1310 will be administered intravenously at 1.6 mg/kg every 21 days. Primary objectives include safety evaluation and confirmed objective response rate by blinded independent central review
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
- •Signed informed consent
- •Adult men and women ≥18 years of age
- •Participants must have histologically confirmed, locally advanced or metastatic NeuroEndocrine Carcionomas (NEC)
- •Participants must be willing to undergo a tumor biopsy or must provide archived tumor tissue sample
- •Participants must have at least one measurable target lesion as defined by RECIST v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy ≥ 3 months
排除标准
- •Participants with another known malignancy that is progressing or requires active treatment within the last 2 years
- •Clinically active central nervous system (CNS) metastases
- •Participants with leptomeningeal metastasis
- •Participants who have received any ADC with a payload of topoisomerase I inhibitor (e.g., exatecan derivative)or had received topoisomerase I inhibitor (e.g., irinotecan) as the immediate prior therapy that the participant had progressed from.
- •Treatment with any systemic anti-cancer treatment or other investigational products/device within 3 weeks before the first dose of study treatment
- •Non-palliative radiotherapy within 2 weeks to non-thoracic area or within 4 weeks to the thoracic area prior to first dose of study treatment or a history of radiation pneumonitis
- •Major surgery within 4 weeks of the first dose of study treatment
- •Hypersensitivity to any ingredient of the study treatment
- •Out of range value (as defined in protocol) within 10 days prior to the first dose of study treatment
- •Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment
- •Lung-specific intercurrent clinically significant illnesses and any autoimmune, connective tissue, or inflammatory disorders including but not limited to pneumonitis
- •Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
- •Pregnant or nursing (lactating) women
- •Participants who have been on concomitant strong CYP3A or CYP2D6 inhibitors within 14 days or 5 half-lives before the first dose of study treatment, whichever is longer
研究组 & 干预措施
Single Arm
Experimental
ZL-1310 as a single agent
干预措施: ZL-1310 (Drug)
结局指标
主要结局
Incidence of Treatment Emergent Adverse-Events in Phase 1b
时间窗: up to 36 months
Number of subjects with treatment-emergent adverse events (TEAEs)
Incidence of Serious Adverse Events in Phase 1b
时间窗: up to 36 months
Number of subjects with serious adverse events (SAEs)
Evaluate antitumor activity of ZL-1310 as a single agent in Phase 2
时间窗: up to 36 months
Confirmed objective response rate (ORR) determined by blinded independent central review (BICR) in Phase 2
Incidence of Treatment Emergent Adverse-Events in Phase 1b
时间窗: up to 31 months
Number of subjects with treatment-emergent adverse events (TEAEs)
Incidence of Serious Adverse Events in Phase 1b
时间窗: up to 31 months
Number of subjects with serious adverse events (SAEs)
Evaluate antitumor activity of ZL-1310 as a single agent in Phase 2
时间窗: up to 31 months
Confirmed objective response rate (ORR) determined by blinded independent central review (BICR) in Phase 2
次要结局
- Evaluate preliminary antitumor activity of ZL-1310 as a single agent in Phase 1b(up to 36 months)
- Evaluate durability of response in Phase 1b(up to 36 months)
- Evaluate preliminary antitumor activity of ZL-1310 as a single agent in Phase 2(up to 36 months)
- Evaluate durability of response in Phase 2(up to 36 months)
- Incidence of Treatment Emergent Adverse-Events in Phase 2(up to 36 months)
- Incidence of Serious Adverse Events in Phase 2(up to 36 months)
- Pharmacokinetics (PK): Time to maximum concentration (Tmax) of Total Antibody in all phases(up to 36 months)
- Pharmacokinetics (PK): maximum concentration (Cmax) of Total Antibody in all phases(up to 36 months)
- Pharmacokinetics (PK): area under the concentration-time curve (AUC) of Total Antibody in all phases(up to 36 months)
- Pharmacokinetics (PK): apparent clearance (CL) of Total Antibody in all phases(up to 36 months)
- Pharmacokinetics (PK): terminal elimination half-life (T1/2) of Total Antibody in all phases(up to 36 months)
- Pharmacokinetics (PK): time to maximum concentration (Tmax) of Unconjugated payloads in all phases(up to 36 months)
- Pharmacokinetics (PK): maximum concentration (Cmax) of Unconjugated payloads in all phases(up to 36 months)
- Pharmacokinetics (PK): area under the concentration-time curve (AUC) of Unconjugated payloads in all phases(up to 36 months)
- Pharmacokinetics (PK): apparent clearance (CL) of Unconjugated payloads in all phases(up to 36 months)
- Pharmacokinetics (PK): terminal elimination half-life (T1/2) of unconjugated payloads in all phases(up to 36 months)
- Assess immunogenicity of ZL-1310 in all phases(up to 36 months)
- Evaluate stability and control of disease in all phases(up to 36 months)
- Evaluate progression-free survival (PFS) in all phases(up to 36 months)
- Evaluate survival in all phases(up to 36 months)
- Evaluate preliminary antitumor activity of ZL-1310 as a single agent in Phase 1b(up to 31 months)
- Evaluate preliminary antitumor activity of ZL-1310 as a single agent in Phase 2(up to 31 months)
- Incidence of Treatment Emergent Adverse-Events in Phase 2(up to 31 months)
- Incidence of Serious Adverse Events in Phase 2(up to 31 months)
- Pharmacokinetics (PK): Time to maximum concentration (Tmax) of Total Antibody in all phases(up to 31 months)
- Pharmacokinetics (PK): maximum concentration (Cmax) of Total Antibody in all phases(up to 31 months)
- Pharmacokinetics (PK): area under the concentration-time curve (AUC) of Total Antibody in all phases(up to 31 months)
- Pharmacokinetics (PK): apparent clearance (CL) of Total Antibody in all phases(up to 31 months)
- Pharmacokinetics (PK): terminal elimination half-life (T1/2) of Total Antibody in all phases(up to 31 months)
- Pharmacokinetics (PK): time to maximum concentration (Tmax) of Unconjugated payloads in all phases(up to 31 months)
- Pharmacokinetics (PK): maximum concentration (Cmax) of Unconjugated payloads in all phases(up to 31 months)
- Pharmacokinetics (PK): area under the concentration-time curve (AUC) of Unconjugated payloads in all phases(up to 31 months)
- Pharmacokinetics (PK): apparent clearance (CL) of Unconjugated payloads in all phases(up to 31 months)
- Pharmacokinetics (PK): terminal elimination half-life (T1/2) of unconjugated payloads in all phases(up to 31 months)
- Assess immunogenicity of ZL-1310 in all phases(up to 31 months)
- Evaluate stability and control of disease in all phases(up to 31 months)
- Evaluate durability of response in all phases(up to 31 months)
- Evaluate progression-free survival (PFS) in all phases(up to 31 months)
- Evaluate survival in all phases(up to 31 months)
研究者
研究点 (53)
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