Advanced Solid Tumor
Conditions
Brief summary
A clinical study to assess dose escalation, tolerance, safety, pharmacokinetics, and multi cohort expansion of ZGGS18 in patients with advanced solid tumors
Interventions
BIOLOGICALZGGS18 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.
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic characteristics of ZGGS18 | Through Phase I study completion, an expected average of 1 year | Peak Plasma Concentration (Cmax) |
| 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 |
| Efficacy of ZGGS18 | Through study completion, an expected average of 3 years | Objective response rate |
Countries
China
Contacts
Primary ContactShangdi Ning
Outcome results
None listed