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

NCT06237400 | Unknown Phase 1

• 1 other identifier: ZG19018-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

KRAS G12C Mutant Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 24 Months

Study Arms (2)

Phase 1 Dose Escalation

EXPERIMENTAL

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.

Drug: ZG19018

Phase 2 Dose Expansion

EXPERIMENTAL

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

Drug: ZG19018

Interventions

ZG19018 DRUG

ZG19018 Given by PO (mouth)

Phase 1 Dose Escalation; Phase 2 Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Study Officials

• Jason Wu

  Suzhou Zelgen Biopharmaceuticals Co.,Ltd

  STUDY CHAIR

Central Study Contacts

Cheng Wei

CONTACT

+86-0512-57309965; weic@zelgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 1, 2024
• Study Start: May 26, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)