NCT07258121 Study of ZGGS34 in Participants With Advanced Solid Tumors
| NCT ID | NCT07258121 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-12-31 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 400 participants in total. It began in 2025-12-31 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Ning Li
PRINCIPAL INVESTIGATOR
Henan Cancer Hospital
Frequently Asked Questions
Who can join the NCT07258121 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07258121 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07258121 currently recruiting?
Yes, NCT07258121 is actively recruiting participants. Contact the research team at jiasy@zelgen.com for enrollment information.
Where is the NCT07258121 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT07258121 clinical trial?
NCT07258121 is sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd. The principal investigator is Ning Li at Henan Cancer Hospital. The trial plans to enroll 400 participants.