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

Suzhou Zelgen Biopharmaceuticals Co.,Ltd2 sites in 1 country222 target enrollmentNovember 15, 2022

ConditionsAdvanced Solid Tumor

InterventionsZGGS18 for Injection

DrugsZGGS18 for Injection

Overview

Phase: Phase 1
Intervention: ZGGS18 for Injection
Conditions: Advanced Solid Tumor
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Enrollment: 222
Locations: 2
Primary Endpoint: Tolerability of ZGGS18
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

November 15, 2022

End Date

November 1, 2026

Last Updated

3 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Responsible Party

Sponsor

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.

Arms & Interventions

Dose Escalation

Intervention: ZGGS18 for Injection

Dose Expansion

Tumor type: colorectal cancer，pancreatic cancer

Intervention: ZGGS18 for Injection

Outcomes

Primary Outcomes

Tolerability of ZGGS18

Time Frame: 28 days

Dose limiting toxicity, number of participants with abnormal laboratory values and/or adverse events that are related to treatment

Safety of ZGGS18

Time Frame: Through study completion, an expected average of 3 years

Number of participants with adverse events/abnormal laboratory values that are related to treatment

Secondary Outcomes

Immunogenicity of ZGGS18(Through study completion, an expected average of 3 years)
Pharmacokinetic characteristics of ZGGS18(Through Phase I study completion, an expected average of 1 year)
Efficacy of ZGGS18(Through study completion, an expected average of 3 years)