Study of ZG005 in Combination With Gecacitinib and Chemotherapy for Participants With Advanced Solid Tumors

NCT07142837 · tracked via the Priya Life Science China tracker

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Phase

Phase 1/2

Started

2025-09

Last updated

2025-08-27

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

ZG005Gecacitinib

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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.

Primary outcome measure(s)

Dose Limiting Toxicity (DLT) — During the first 28 days
Objective Response Rate (ORR) — Up to 2 years
Adverse events (AEs) — Up to 2 years

Trial sites (1)

Facility	City	Region	Status
Chinese PLA General Hosptial	Beijing	Beijing Municipality

More Suzhou Zelgen Biopharmaceuticals Co.,Ltd trials in China

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A Pharmacokinetic Study of Gecacitinib Hydrochloride Tablets in Healthy Adult Participants. Active, not recruiting

Study of ZG006 in Participants With Neuroendocrine Prostate Cancer Starting soon

Study of ZG005 in Combination With Platinum-Based Chemotherapy in Participants With Advanced Biliary Tract Carcinoma Recruiting

Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer Recruiting

Other trials for the same condition

A Study of MHB036C for Advanced Solid Tumor Active, not recruiting

A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors Active, not recruiting

Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors Recruiting

HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors Recruiting

A Clinical Study of [177Lu]Lu-XT117 Injection in Patients With Advanced Solid Tumors Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07142837 on ClinicalTrials.gov ↗ ← All trials in China