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

Zelgen Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Solid Tumor; KRAS Mutation-Related Tumors

Treatments: Drug: ZG2001 Tosilate Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06237413

ZG2001-001

Details and patient eligibility

About

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

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Phase 1 Dose Escalation

Experimental group

Description:

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）.

Treatment:

Drug: ZG2001 Tosilate Tablets

Phase 2 Dose Expansion

Experimental group

Description:

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

Treatment:

Drug: ZG2001 Tosilate Tablets