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

Phase 2RecruitingNCT06237413

Suzhou Zelgen Biopharmaceuticals Co.,Ltd110 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Solid Tumor KRAS Mutation-Related Tumors

Interventions

ZG2001 Tosilate TabletsDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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 1st treatment cycle of ZG2001 (Day 1 through Day 21) where the relationship to ZG2001 cannot be ruled out.

Time frame: Up to 21 Days

Incidence of Treatment-Emergent Adverse Events

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0

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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