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

Last updated: March 4, 2024
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Neuroblastoma

Treatment

ZG2001 Tosilate Tablets

Clinical Study ID

NCT06237413
ZG2001-001
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Received any SOS1 inhibitors;
  • Participants with a known history of hypersensitivity reactions to the ingredients ofthe preparations used in this study;
  • Other conditions that the investigator considers to be unsuitable for participation inthis study.

Study Design

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: ZG2001 Tosilate Tablets
Phase: 1/2
Study Start date:
August 10, 2023
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • Chinese PLA General Hospital

    Beijing, Beijing 100853
    China

    Active - Recruiting

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