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Clinical trial

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

ID
Name
ZGGS18-001
Description
A clinical study to assess dose escalation, tolerance, safety, pharmacokinetics, and multi cohort expansion of ZGGS18 in patients with advanced solid tumors
Trial arms
Trial start
2022-11-15
Estimated PCD
2024-11-01
Trial end
2025-11-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Dose Escalation
ZGGS18 for Injection
Recommended Phase 2 Dose (RP2D) (to be determined) of ZGGS18，intravenous infusion, once every 2 weeks.
Arms:
Dose Expansion
Size
222
Primary endpoint
Tolerability of ZGGS18
28 days
Safety of ZGGS18
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 222, 'type': 'ESTIMATED'}}
Updated at
2023-08-15

1 organization

1 product

1 abstract

1 indication

Organization
Suzhou Zelgen Biopharmaceuticals
Product
ZGGS18
Indication
Advanced Solid Tumor
Abstract
First-in-human study of ZGGS18, a dual specific antibody targeting VEGF and TGF-β, as monotherapy in patients with advanced solid tumors.
Org: ChangSha TaiHe Hospital, Shulan (Hangzhou) Hospital, Deyang People's Hospital, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Anhui Provincal Hospital,