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Not yet recruiting NCT07142837

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

Phase I / Phase II Interventional Advanced Solid Tumor

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ZG005, Gecacitinib.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Study to Evaluate the Efficacy and Safety of ZG005 in Combination With Gecacitinib and Chemotherapy for Participants With Advanced Solid Tumors

Overview

This is a multicenter, open-label phase I/II study for participants with advanced solid tumors who have failed prior immune checkpoint inhibitor therapies.

Interventions

  • Drug ZG005
    ZG005 20mg/kg; once every 3 weeks；IV infusion
  • Drug 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.

Primary outcome measures

  • Dose Limiting Toxicity (DLT) [Time frame: During the first 28 days]
  • Objective Response Rate (ORR) [Time frame: Up to 2 years]
  • Adverse events (AEs) [Time frame: Up to 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Chinese PLA General Hosptial — Beijing

Identifiers

NCT: NCT07142837 · ZG005-JAK-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗