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

Phase 1

Recruiting

• Conditions: KRAS G12C Mutant Advanced Solid Tumors
• Interventions: Drug: ZG19018

• Registration Number: NCT06237400
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-26
• Status Verified: 2024-01
• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-23
• Last Update Submitted: 2024-01-23
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1 Dose Escalation	ZG19018	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.
Phase 2 Dose Expansion	ZG19018	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

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity (DLT)	Up to 21Days	A DLT is defined as any Grade ≥ 3 AE meeting the criteria listed below occurring during the first treatment cycle of ZG19018 (day 1 through day 21) where elationship to ZG19018 cannot be ruled out.
Objective Response Rate (ORR)	Up to 24 Months	The sum of the proportions of subjects who achieved CR or PR in imaging evaluation as assessed by the investigator based on RECIST1.1 criteria.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China