ZGGS34 treatment for adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label Phase 1/2 trial with a dose-escalation Part 1 to find safe dosing and a cohort-expansion Part 2 to measure efficacy in selected MUC17-positive tumors. Part 1 enrolls adults with histologically confirmed advanced solid tumors who have exhausted or are intolerant to standard treatments. Part 2 enrolls tumor-specific cohorts (including gastric, pancreatic, and colorectal cancer) and may combine ZGGS34 with chemotherapy for MUC17-positive patients. Tumor tissue or fresh biopsy is required for MUC17 testing and participants must be able to attend study visits and biopsies at the listed sites.

Why it matters

Who can join: the full rules

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.

Where it's running

• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting

Study contacts

• Principal investigator: Ning Li — Henan Cancer Hospital
• Study coordinator: Shuangyu Jia
• Email: jiasy@zelgen.com
• Phone: 18039230612

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.