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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-26

Study Completion Date

2025-05-31

Brief Summary

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

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Detailed Description

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Conditions

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KRAS G12C Mutant Advanced Solid Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1 Dose Escalation

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.

Group Type EXPERIMENTAL

ZG19018

Intervention Type DRUG

ZG19018 Given by PO (mouth)

Phase 2 Dose Expansion

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

Group Type EXPERIMENTAL

ZG19018

Intervention Type DRUG

ZG19018 Given by PO (mouth)

Interventions

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ZG19018

ZG19018 Given by PO (mouth)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No