Study of ZGGS18 in Patients With Advanced Solid Tumors
Phase 1
Recruiting
- Conditions
- Advanced Solid Tumor
- Interventions
- Biological: ZGGS18 for Injection
- Registration Number
- NCT05584800
- Lead Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Brief Summary
A clinical study to assess dose escalation, tolerance, safety, pharmacokinetics, and multi cohort expansion of ZGGS18 in patients with advanced solid tumors
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 222
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation ZGGS18 for Injection - Dose Expansion ZGGS18 for Injection Tumor type: colorectal cancer，pancreatic cancer
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Efficacy of ZGGS18 Through study completion, an expected average of 3 years Time to progression
Pharmacokinetic characteristics of ZGGS18 Through Phase I study completion, an expected average of 1 year Elimination half-life (t1/2)
Immunogenicity of ZGGS18 Through study completion, an expected average of 3 years Detection of anti-drug antibodies, if positive, further detection of neutralizing antibodies. Counting the number of patients and incidence of anti-drug antibodies and neutralizing antibodies
Trial Locations
- Locations (1)
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China