ZGGS34 treatment for adults 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
This trial will try the experimental drug ZGGS34 in adults with advanced MUC17-positive solid tumors to see if it is safe and can shrink tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Drugs / interventions | Chemotherapy, immunotherapy |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT07258121 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–75 with advanced solid tumors that test positive for MUC17 who have failed or are intolerant to standard therapies (with cohort-specific requirements such as HER2-negative status for gastric cancer and prior lines of therapy for pancreatic and colorectal cohorts).
Not a fit: Patients whose tumors do not express MUC17, those currently well controlled on standard therapy, or those unable to undergo required biopsies or meet safety criteria are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, ZGGS34 could offer a new targeted option for patients with MUC17-positive advanced solid tumors and potentially improve tumor control.
How similar studies have performed: Direct clinical data on MUC17-targeted agents are limited, though other antigen-directed therapies (for example HER2- or EGFR-targeted drugs) have shown meaningful benefit in selected tumor types.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Zhengzhou, Henan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.