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Clinical Trials in China / NCT07142837
Starting soon Phase 1/2

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)

ZG005 →Gecacitinib →

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
No
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)

FacilityCityRegionStatus
Chinese PLA General Hosptial Beijing Beijing Municipality

More Suzhou Zelgen Biopharmaceuticals Co.,Ltd trials in China

ZG005 Plus Bevacizumab vs Sintilimab Plus Bevacizumab as First-Line Therapy for Advanced Hepatocellular Starting soon
Study Comparing ZG006 With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer Recruiting
Study of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors Recruiting
A Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma Starting soon
Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Neuroendocrine Carcinoma. Recruiting

Other trials for the same condition

Study of SGN1 in Patients With Advanced Solid Tumor Recruiting
Clinical Trial of BT02 in Patients With Advanced Solid Tumors Recruiting
A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Immunogenicity, and Preliminary Efficacy of SGT003 in Patients With Advanced Solid Tumors Recruiting
A Study of RC118 in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors Recruiting
A Study of the ILB-3101 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