Study of ZGGS18 in Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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A clinical study to assess dose escalation, tolerance, safety, pharmacokinetics, and multi cohort expansion of ZGGS18 in patients with advanced solid tumors

Official Title
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A Phase I/II Dose Escalation, Tolerability, Safety, Pharmacokinetics and Multiple Cohort Expansion Study of ZGGS18 in Patients With Advanced Solid Tumors

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Biological: ZGGS18 for Injection
* Biological: ZGGS18 for Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Escalation<br> | Biological: ZGGS18 for Injection<br>* 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.<br>|
| Experimental: Dose Expansion<br>Tumor type: colorectal cancer，pancreatic cancer | Biological: ZGGS18 for Injection<br>* Recommended Phase 2 Dose (RP2D) (to be determined) of ZGGS18，intravenous infusion, once every 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of ZGGS18 | Dose limiting toxicity, number of participants with abnormal laboratory values and/or adverse events that are related to treatment | 28 days | 
| Safety of ZGGS18 | Number of participants with adverse events/abnormal laboratory values that are related to treatment | Through study completion, an expected average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic characteristics of ZGGS18 | Peak Plasma Concentration (Cmax) | Through Phase I study completion, an expected average of 1 year | 
| Pharmacokinetic characteristics of ZGGS18 | Time to maximum concentration (Tmax) | Through Phase I study completion, an expected average of 1 year | 
| Pharmacokinetic characteristics of ZGGS18 | Clearance (CL/F) | Through Phase I study completion, an expected average of 1 year | 
| Pharmacokinetic characteristics of ZGGS18 | Area under drug concentration-time curve | Through Phase I study completion, an expected average of 1 year | 
| Pharmacokinetic characteristics of ZGGS18 | Elimination rate constant (Ke) | Through Phase I study completion, an expected average of 1 year | 
| Pharmacokinetic characteristics of ZGGS18 | Elimination half-life (t1/2) | Through Phase I study completion, an expected average of 1 year | 
| Immunogenicity of ZGGS18 | 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 | Through study completion, an expected average of 3 years | 
| Efficacy of ZGGS18 | Objective response rate | Through study completion, an expected average of 3 years | 
| Efficacy of ZGGS18 | Progression-free survival | Through study completion, an expected average of 3 years | 
| Efficacy of ZGGS18 | Disease control rate | Through study completion, an expected average of 3 years | 
| Efficacy of ZGGS18 | Duration of response | Through study completion, an expected average of 3 years | 
| Efficacy of ZGGS18 | Time to response | Through study completion, an expected average of 3 years | 
| Efficacy of ZGGS18 | Time to progression | Through study completion, an expected average of 3 years |