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

Zelgen Biopharmaceuticals

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: ZG005; Drug: Gecacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07142837

ZG005-JAK-004

Details and patient eligibility

About

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

Enrollment: 153 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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153 participants in 2 patient groups

Part 1: Dose Escalation

Experimental group

Description:

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

Treatment:

Drug: Gecacitinib

Drug: ZG005

Part 2: Dose Expansion

Experimental group

Description:

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

Treatment:

Drug: Gecacitinib

Drug: ZG005