A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations

  • STATUS
    Recruiting
  • End date
    Apr 10, 2024
  • participants needed
    128
  • sponsor
    Zhejiang Genfleet Therapeutics Co., Ltd.
Updated on 4 October 2022

Summary

Phase I: To evaluate the safety and tolerability of GFH925 in subjects with KRAS G12C mutant advanced solid tumors and estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D).Phase II: To evaluate the efficacy of GFH925 in subjects with KRAS G12C mutant advanced non-small cell lung cancer (NSCLC).

Details
Condition KRAS G12C
Treatment GFH925
Clinical Study IdentifierNCT05005234
SponsorZhejiang Genfleet Therapeutics Co., Ltd.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Men or women ≥18 years old
Pathologically diagnosed, previously treated, advanced tumor with KRAS p.G12C mutation
Adequate organ function
Measurable disease per RECIST 1.1 criteria

Exclusion Criteria

Significant concomitant diseases
Active brain metastases
Previous treatment with KRAS G12C inhibitor
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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