Study of ZGGS34 in Participants With Advanced Solid Tumors
A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZGGS34 in Participants With Advanced Solid Tumors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
400 participants
Dec 31, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria2
- 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.
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Interventions
ZG006 will be administered as an intravenous (IV) infusion.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07258121