ZGGS18 for Injection: 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 10 mg/kg, 15 mg/kg and 20 mg/kgof ZGGS18，intravenous infusion, once every 2 weeks.
ZGGS18 for Injection: Recommended Phase 2 Dose (RP2D) (to be determined) of ZGGS18，intravenous infusion, once every 2 weeks.
Study summary
A clinical study to assess dose escalation, tolerance, safety, pharmacokinetics, and multi cohort expansion of ZGGS18 in patients with advanced solid tumors
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of advanced solid tumors, who had failed the available standard treatments or no standard treatment or intolerance to standard treatment;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
* Life expectancy ≥ 3 months;
* Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1). For lesions that have received radiation therapy, only after the progression of the lesions, they can be considered measurable lesions.
Exclusion Criteria:
* The investigator considers that any subjects are not suitable to participate in the trial.
Primary outcome measure(s)
Tolerability of ZGGS18 — 28 days Dose limiting toxicity, number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Safety of ZGGS18 — Through study completion, an expected average of 3 years Number of participants with adverse events/abnormal laboratory values that are related to treatment
Trial sites (1)
Facility
City
Region
Status
Chinese PLA General Hospital
Beijing
Beijing Municipality
Recruiting
More Suzhou Zelgen Biopharmaceuticals Co.,Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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