A Study of ZG19018 in Patients With KRAS G12C Mutant Advanced Solid Tumors.

Zelgen Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: KRAS G12C Mutant Advanced Solid Tumors

Treatments: Drug: ZG19018

Study type: Interventional

Funder types: Industry

Identifiers

NCT06237400

ZG19018-001

Details and patient eligibility

About

Evaluate the safety and tolerability of ZG19018 in Patients with KRAS G12C mutant advanced solid tumors.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who fully understood this trial and voluntarily signed the informed consent form;
• Men or women ≥ 18 years old;
• ECOG Performance Status (PS) 0 or 1;
• Life expectancy > 3 months.

Exclusion criteria

• Received any treatment with inhibitors against KRAS G12C mutation at any time, e.g., AMG 510, MRTX 849, etc.;
• Patients requiring medications that can potentially prolong QTc interval;
• Other conditions that the investigator considers to be unsuitable for participation in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Phase 1 Dose Escalation

Experimental group

Description:

Dose escalation will begin with rapid dose escalation for the low-dose groups (50 mg QD 、150 mg QD) and a "3 + 3" dose-escalation protocol for the high-dose groups.

Treatment:

Drug: ZG19018

Phase 2 Dose Expansion

Experimental group

Description:

Upon completing the dose escalation part of the study, dose expansion may proceed with 3 groups consisting of subjects with KRAS G12C mutant advanced solid tumors，Including non-small cell lung cancer, colorectal cancer and Other advanced solid tumors

Treatment:

Drug: ZG19018