A Study of ZG2001 in Participants With KRAS Mutated Advanced Solid Tumours

NCT ID: NCT06237413

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-10
• Study Completion Date: 2026-02-28

Brief Summary

This study will evaluate the tolerability, safety, effects, and pharmacokinetics of ZG2001 in Participants with advanced solid tumors that have a KRAS mutation.

Conditions

Solid Tumor; KRAS Mutation-Related Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1 Dose Escalation

This Phase adopts an open-label design, with an Accelerated Titration(AT) design for the low-dose group (50 mg Bid) and the standard "3+3" design for the high-dose groups（100 mg Bid、50 mg Qd、100 mg Qd、200 mg Qd）.

Group Type: EXPERIMENTAL

ZG2001 Tosilate Tablets

Intervention Type: DRUG

ZG2001 will be administered orally once or twice daily in a continuous regimen

Phase 2 Dose Expansion

After the completion of the dose escalation study, RP2D will be selected for dose expansion in advanced solid tumors (such as non-small cell lung cancer, colorectal cancer, pancreatic cancer, etc.) with KRAS mutations that have failed at least the first-line standard treatment

Group Type: EXPERIMENTAL

ZG2001 Tosilate Tablets

Intervention Type: DRUG

ZG2001 will be administered orally once or twice daily in a continuous regimen

Interventions

ZG2001 Tosilate Tablets

ZG2001 will be administered orally once or twice daily in a continuous regimen

Intervention Type: DRUG

Other Intervention Names

ZG2001

Eligibility Criteria

Inclusion Criteria

• Participants who fully understood this study and voluntarily signed the informed consent form;
• Men or women ≥ 18 years old;
• Participants with a KRAS mutant solid tumor should have progressed on or are ineligible for all therapy(ies) known to confer clinical benefit.
• ECOG Performance Status (PS) 0 or 1;
• Life expectancy > 3 months.

Exclusion Criteria

• Received any SOS1 inhibitors;
• Participants with a known history of hypersensitivity reactions to the ingredients of the preparations used in this study;
• 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

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Wu

Role: STUDY_CHAIR

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Cheng Wei

Role: CONTACT

weic@zelgen.com

+86-0512-57309965

Facility Contacts

Jianming Xu

Role: primary

jmxu2003@163.com

Other Identifiers

ZG2001-001

Identifier Type: -

Identifier Source: org_study_id