Actively Recruiting
Study of ZGGS34 in Participants With Advanced Solid Tumors
Led by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Updated on 2026-04-28
400
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of ZGGS34 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study and voluntarily sign the informed consent form
- Male or female aged 18 to 75 years
- Provide archived tumor tissue within 24 months or fresh biopsy for MUC17 expression testing, with positive MUC17 required
- For Part 1: Have histologically or cytologically confirmed advanced solid tumors that failed standard treatment or have no standard treatment available, or are intolerant to standard treatments
- For Part 2: Cohort 1 (Gastric cancer): Previously received at least one line of systemic treatment and failed, HER2 negative
- For Part 2: Cohort 2 (Pancreatic cancer): Previously received at least one line of systemic treatment and failed
- For Part 2: Cohort 3 (Colorectal cancer): Previously received at least one line of systemic treatment and failed; if MSI-H/dMMR, prior PD-1 therapy is required
- For Part 2: Cohort 4: Other advanced solid tumor patients who failed standard treatment or have no standard treatment available
You will not qualify if you...
- Received prior combination or sequential drugs targeting anti-MUC17, including investigational drugs
- Received chemotherapy, immunotherapy, targeted therapy, endocrine therapy, or biological targeted medicines within 4 weeks before the first dose
- Received local palliative radiotherapy or small molecule targeted therapy within 2 weeks before the first dose
- Used systemic immunosuppressive medications, such as corticosteroids, within 14 days before the first dose
- Received any live or live attenuated vaccines against viral infections within 4 weeks of the first dose
- Considered unsuitable for enrollment by the investigator for any other reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
Research Team
S
Shuangyu Jia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here