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

Phase 1

Recruiting

• Conditions: Solid Tumor; KRAS Mutation-Related Tumors
• Interventions: Drug: ZG2001 Tosilate Tablets

• Registration Number: NCT06237413
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-10
• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-02-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 2 Dose Expansion	ZG2001 Tosilate Tablets	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
Phase 1 Dose Escalation	ZG2001 Tosilate Tablets	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）.

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity (DLT)	Up to 21 Days	A DLT is defined as any Grade ≥ 3 AE meeting the criteria listed below occurring during the 1st treatment cycle of ZG2001 (Day 1 through Day 21) where the relationship to ZG2001 cannot be ruled out.
Incidence of Treatment-Emergent Adverse Events	Up to 24 Months	Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0

Trial Locations

Locations (1)

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