Study of ZG005 in Combination With Gecacitinib and Chemotherapy for Participants With Advanced Solid Tumors
Not Applicable
Not yet recruiting
- Conditions
- Advanced Solid Tumor
- Interventions
- Drug: Gecacitinib
- Registration Number
- NCT07142837
- Lead Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Brief Summary
This is a multicenter, open-label phase I/II study for participants with advanced solid tumors who have failed prior immune checkpoint inhibitor therapies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 153
Inclusion Criteria
- Fully understand the study and voluntarily sign the informed consent form.
- Male or female 18-75 years of age.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- PART 1: Histologically confirmed unresectable locally advanced, recurrent, or metastatic solid tumors.PART 2 Cohort A: Histologically confirmed unresectable locally advanced, recurrent, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. Cohort B: Histologically confirmed unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma. Cohort C: Histologically confirmed unresectable locally advanced, recurrent, or metastatic other solid tumors.
- Life expectancy ≥ 3 months.
Exclusion Criteria
- participants were deemed unsuitable for participating in the study by the investigator for any reasons.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Dose Escalation ZG005 Dose-escalation study of ZG005 in combination with Gecacitinib and Chemotherapy. Part 1: Dose Escalation Gecacitinib Dose-escalation study of ZG005 in combination with Gecacitinib and Chemotherapy. Part 2: Dose Expansion ZG005 Cohort A: HER2-negative gastric or gastroesophageal junction adenocarcinoma; Cohort B: Esophageal squamous cell carcinoma; Cohort C: other Solid Tumors. Part 2: Dose Expansion Gecacitinib Cohort A: HER2-negative gastric or gastroesophageal junction adenocarcinoma; Cohort B: Esophageal squamous cell carcinoma; Cohort C: other Solid Tumors.
- Primary Outcome Measures
Name Time Method Dose Limiting Toxicity (DLT) During the first 28 days Objective Response Rate (ORR) Up to 2 years Adverse events (AEs) Up to 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chinese PLA General Hosptial
🇨🇳Beijing, Beijing Municipality, China
Chinese PLA General Hosptial🇨🇳Beijing, Beijing Municipality, China