A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZGGS34 in Participants With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The incidence of dose-limiting toxicity (DLT)
研究概览
简要总结
This is a multicenter, open-label Phase 1/2 study in participants with advanced solid tumors. The study consists of two parts: Part 1 is a dose-escalation phase to evaluate the safety and tolerability of ZGGS34 in advanced solid tumor participants; Part 2 is a cohort-expansion phase to assess the efficacy and safety of ZGGS34 (± chemotherapy) in selected MUC17-positive advanced solid tumor participants.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully understand the study and voluntarily sign the informed consent form;
- •Male or female 18~75 years old.
- •Archived tumor tissue within 24 months or fresh biopsy specimens must be provided for detection of MUC17 expression, and with positive MUC17 results required.
- •Subjects in different study parts need to meet the following requirements:
- •Part 1: Dose Escalation Study：Histologically or cytologically confirmed advanced solid tumors who have failed standard treatment or no standard treatment available, or were intolerant to standard treatments.
- •Part 2: Cohort Expansion Study：Cohort 1 (Gastric cancer): Previously received at least one line systematic treatment and failed; HER2 status negative. Cohort 2 (Pancreatic cancer): Previously received at least one line systematic treatment and failed. Cohort 3 (Colorectal cancer): Previously received at least one line systematic treatment and failed; If patients with MSI-H/dMMR, prior PD-1 therapy is required. Cohort 4: Other patients with advanced solid tumors who have failed standard treatment or have no standard treatment available.
排除标准
- •Patients having received any of the following treatments: Prior combination or sequential use of drugs targeting anti-MUC17 (including investigational drugs);Chemotherapy, immunotherapy, targeted therapy, endocrine therapy, and biological targeted medicines ≤ 4 weeks before the first dose. Local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks before the first dose; Systemic immunosuppressive medications, such as corticosteroid within 14 days prior to the first dose; Use of any live or live attenuated vaccines against viral infections within 4 weeks of first dose.
- •The investigator considers the subject unsuitable for enrollment in this clinical study for any other reason.
研究组 & 干预措施
Part 2: Dose Expansion
Based on the RP2D identified in the Part 1 dose-escalation study of ZGGS34, expansion cohorts will be enrolled distinct solid-tumor populations to further evaluate the preliminary efficacy and safety of the selected ZGGS34 monotherapy dose.
干预措施: ZG006 (Biological)
Part 1: Dose Escalation
A rapid titration followed by the traditional "3 + 3" design will be used for dose escalation: rapid titration is applied to the first cohort, and the conventional "3 + 3" method is used for all subsequent cohorts. Dose escalation is planned to proceed through the following dose levels: 0.5 mg, 1.5 mg, 5.0 mg, 15.0 mg, 30.0 mg, 60.0 mg, and 100.0 mg. The initial dosing frequency is set at once every two weeks (Q2W).
干预措施: ZG006 (Biological)
结局指标
主要结局
The incidence of dose-limiting toxicity (DLT)
时间窗: Up to 28 days
Incidence of Treatment-emergent adverse events (TEAEs)
时间窗: Up to 2 years
次要结局
未报告次要终点