Study of ZG005 in Combination With Gecacitinib and Chemotherapy for Participants With Advanced Solid Tumors
NCT ID: NCT07142837
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
153 participants
INTERVENTIONAL
2025-09-30
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Dose Escalation
Dose-escalation study of ZG005 in combination with Gecacitinib and Chemotherapy.
ZG005
ZG005 20mg/kg; once every 3 weeks；IV infusion
Gecacitinib
Gecacitinib for dose escalations are set as 100mg Bid po. Gecacitinib for dose expansion will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.
Part 2: Dose Expansion
Cohort A: HER2-negative gastric or gastroesophageal junction adenocarcinoma; Cohort B: Esophageal squamous cell carcinoma; Cohort C: other Solid Tumors.
ZG005
ZG005 20mg/kg; once every 3 weeks；IV infusion
Gecacitinib
Gecacitinib for dose escalations are set as 100mg Bid po. Gecacitinib for dose expansion will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.
Interventions
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ZG005
ZG005 20mg/kg; once every 3 weeks；IV infusion
Gecacitinib
Gecacitinib for dose escalations are set as 100mg Bid po. Gecacitinib for dose expansion will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Suzhou Zelgen Biopharmaceuticals Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Jason Wu
Role: STUDY_CHAIR
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Locations
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Chinese PLA General Hosptial
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Other Identifiers
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ZG005-JAK-004
Identifier Type: -
Identifier Source: org_study_id
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