Study of ZGGS34 in Participants With Advanced Solid Tumors

NCT ID: NCT07258121

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-12-31

Brief Summary

This is a multicenter, open-label Phase 1/2 study in participants with advanced solid tumors. The study consists of two parts: Part 1 is a dose-escalation phase to evaluate the safety and tolerability of ZGGS34 in advanced solid tumor participants; Part 2 is a cohort-expansion phase to assess the efficacy and safety of ZGGS34 (± chemotherapy) in selected MUC17-positive advanced solid tumor participants.

Conditions

Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: Dose Escalation

A rapid titration followed by the traditional "3 + 3" design will be used for dose escalation: rapid titration is applied to the first cohort, and the conventional "3 + 3" method is used for all subsequent cohorts. Dose escalation is planned to proceed through the following dose levels: 0.5 mg, 1.5 mg, 5.0 mg, 15.0 mg, 30.0 mg, 60.0 mg, and 100.0 mg. The initial dosing frequency is set at once every two weeks (Q2W).

Group Type: EXPERIMENTAL

ZG006

Intervention Type: BIOLOGICAL

ZG006 will be administered as an intravenous (IV) infusion.

Part 2: Dose Expansion

Based on the RP2D identified in the Part 1 dose-escalation study of ZGGS34, expansion cohorts will be enrolled distinct solid-tumor populations to further evaluate the preliminary efficacy and safety of the selected ZGGS34 monotherapy dose.

Group Type: EXPERIMENTAL

ZG006

Intervention Type: BIOLOGICAL

ZG006 will be administered as an intravenous (IV) infusion.

Interventions

ZG006

ZG006 will be administered as an intravenous (IV) infusion.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Fully understand the study and voluntarily sign the informed consent form;
• Male or female 18~75 years old.
• Archived tumor tissue within 24 months or fresh biopsy specimens must be provided for detection of MUC17 expression, and with positive MUC17 results required.
• Subjects in different study parts need to meet the following requirements:

Part 1: Dose Escalation Study： Histologically or cytologically confirmed advanced solid tumors who have failed standard treatment or no standard treatment available, or were intolerant to standard treatments.

Part 2: Cohort Expansion Study： Cohort 1 (Gastric cancer): Previously received at least one line systematic treatment and failed; HER2 status negative; Cohort 2 (Pancreatic cancer): Previously received at least one line systematic treatment and failed; Cohort 3 (Colorectal cancer): Previously received at least one line systematic treatment and failed; If patients with MSI-H/dMMR, prior PD-1 therapy is required. Cohort 4: Other patients with advanced solid tumors who have failed standard treatment or have no standard treatment available.

Exclusion Criteria

• Patients having received any of the following treatments:

Prior combination or sequential use of drugs targeting anti-MUC17 (including investigational drugs);Chemotherapy, immunotherapy, targeted therapy, endocrine therapy, and biological targeted medicines ≤ 4 weeks before the first dose. Local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks before the first dose; Systemic immunosuppressive medications, such as corticosteroid within 14 days prior to the first dose; Use of any live or live attenuated vaccines against viral infections within 4 weeks of first dose.

• The investigator considers the subject unsuitable for enrollment in this clinical study for any other reason.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ning Li

Role: PRINCIPAL_INVESTIGATOR

Henan Cancer Hospital

Central Contacts

Shuangyu Jia

Role: CONTACT

jiasy@zelgen.com

18039230612

Other Identifiers

ZGGS34-001

Identifier Type: -

Identifier Source: org_study_id