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Clinical trial

A Phase I/II Dose Escalation Study to Evaluating the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG2001 Tosilate Tablets in Participants With KRAS Mutated Advanced Solid Tumours

ID
Name
ZG2001-001
Description
This study will evaluate the tolerability, safety, effects, and pharmacokinetics of ZG2001 in Participants with advanced solid tumors that have a KRAS mutation.
Trial arms
Trial start
2023-08-10
Estimated PCD
2026-02-01
Trial end
2026-02-01
Status
Recruiting
Phase
Early phase I
Treatment
ZG2001 Tosilate Tablets
ZG2001 will be administered orally once or twice daily in a continuous regimen
Arms:
Phase 1 Dose Escalation, Phase 2 Dose Expansion
Other names:
ZG2001
Size
110
Primary endpoint
Dose Limiting Toxicity (DLT)
Up to 21 Days
Incidence of Treatment-Emergent Adverse Events
Up to 24 Months
Eligibility criteria
Inclusion Criteria: * Participants who fully understood this study and voluntarily signed the informed consent form; * Men or women ≥ 18 years old; * Participants with a KRAS mutant solid tumor should have progressed on or are ineligible for all therapy(ies) known to confer clinical benefit. * ECOG Performance Status (PS) 0 or 1; * Life expectancy \> 3 months. Exclusion Criteria: * Received any SOS1 inhibitors; * Participants with a known history of hypersensitivity reactions to the ingredients of the preparations used in this study; * Other conditions that the investigator considers to be unsuitable for participation in this study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 110, 'type': 'ESTIMATED'}}
Updated at
2024-03-06

1 organization

1 product

2 indications

Organization
Suzhou Zelgen Biopharmaceuticals
Product
ZG2001
Indication
Solid Tumor
Indication
KRAS Mutation-Related Tumors