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

NCT07142837 | Not Yet Recruiting Phase 1

• 1 other identifier: ZG005-JAK-004
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Dose Limiting Toxicity (DLT)

  During the first 28 days

• Objective Response Rate (ORR)

  Up to 2 years

• Adverse events (AEs)

  Up to 2 years

Study Arms (2)

Part 1: Dose Escalation

EXPERIMENTAL

Dose-escalation study of ZG005 in combination with Gecacitinib and Chemotherapy.

Drug: ZG005; Drug: Gecacitinib

Part 2: Dose Expansion

EXPERIMENTAL

Cohort A: HER2-negative gastric or gastroesophageal junction adenocarcinoma; Cohort B: Esophageal squamous cell carcinoma; Cohort C: other Solid Tumors.

Drug: ZG005; Drug: Gecacitinib

Interventions

ZG005 DRUG

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

Part 1: Dose Escalation; Part 2: Dose Expansion

Gecacitinib DRUG

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 1: Dose Escalation; Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• participants were deemed unsuitable for participating in the study by the investigator for any reasons.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Chinese PLA General Hosptial

Beijing, Beijing Municipality, China

Location

Study Officials

• Jason Wu

  Suzhou Zelgen Biopharmaceuticals Co.,Ltd

  STUDY CHAIR

Central Study Contacts

Bo Liu

CONTACT

051257309965; liub@zelgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 27, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

CN (1)