Recruiting NCT05584800
Study of ZGGS18 in Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ZGGS18 for Injection, ZGGS18 for Injection.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumor. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I/II Dose Escalation, Tolerability, Safety, Pharmacokinetics and Multiple Cohort Expansion Study of ZGGS18 in Patients With Advanced Solid Tumors
Overview
A clinical study to assess dose escalation, tolerance, safety, pharmacokinetics, and multi cohort expansion of ZGGS18 in patients with advanced solid tumors
Interventions
- Biological 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. - Biological ZGGS18 for Injection
Recommended Phase 2 Dose (RP2D) (to be determined) of ZGGS18，intravenous infusion, once every 2 weeks.
Primary outcome measures
- Tolerability of ZGGS18 [Time frame: 28 days]
- Safety of ZGGS18 [Time frame: Through study completion, an expected average of 3 years]
Secondary outcome measures (12)
- Pharmacokinetic characteristics of ZGGS18 [Time frame: Through Phase I study completion, an expected average of 1 year]
- Pharmacokinetic characteristics of ZGGS18 [Time frame: Through Phase I study completion, an expected average of 1 year]
- Pharmacokinetic characteristics of ZGGS18 [Time frame: Through Phase I study completion, an expected average of 1 year]
- Pharmacokinetic characteristics of ZGGS18 [Time frame: Through Phase I study completion, an expected average of 1 year]
- Pharmacokinetic characteristics of ZGGS18 [Time frame: Through Phase I study completion, an expected average of 1 year]
- Pharmacokinetic characteristics of ZGGS18 [Time frame: Through Phase I study completion, an expected average of 1 year]
- Immunogenicity of ZGGS18 [Time frame: Through study completion, an expected average of 3 years]
- Efficacy of ZGGS18 [Time frame: Through study completion, an expected average of 3 years]
- Efficacy of ZGGS18 [Time frame: Through study completion, an expected average of 3 years]
- Efficacy of ZGGS18 [Time frame: Through study completion, an expected average of 3 years]
- Efficacy of ZGGS18 [Time frame: Through study completion, an expected average of 3 years]
- Efficacy of ZGGS18 [Time frame: Through study completion, an expected average of 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chinese PLA General Hospital — Beijing
Identifiers
NCT: NCT05584800 · ZGGS18-001