Recruiting
Phase 1/2
Study of ZGGS34 in Participants With Advanced Solid Tumors
Condition(s) studied
Solid Tumor
Investigational drug(s) / intervention(s)
ZG006: ZG006 will be administered as an intravenous (IV) infusion.
Study 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 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.
Primary outcome measure(s)
- The incidence of dose-limiting toxicity (DLT) — Up to 28 days
- Incidence of Treatment-emergent adverse events (TEAEs) — Up to 2 years
Trial sites (1)
| Facility | City | Region | Status |
| Henan Cancer Hospital |
Zhengzhou |
Henan |
Recruiting |
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