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

Phase 2UnknownNCT06237400

Suzhou Zelgen Biopharmaceuticals Co.,Ltd110 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

KRAS G12C Mutant Advanced Solid Tumors

Interventions

ZG19018DRUG

ZG19018 Given by PO (mouth)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Dose Limiting Toxicity (DLT)

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.

Time frame: Up to 21Days

Objective Response Rate (ORR)

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.

Time frame: Up to 24 Months

Central Contacts

Cheng Wei

CONTACT

+86-0512-57309965 weic@zelgen.com

Data from ClinicalTrials.gov

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