Active — Not RecruitingPhase 1

GH35 Tablets for Advanced Solid Tumors: A Study on Safety and Early Results

China18 participantsStarted 2021-09-27

Plain-language summary

Evaluate the safety and tolerability of GH35 in patients with KRAS mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in patients with KRAS mutant advanced solid tumors.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female subjects greater than or equal to 18 years old.
✓. Histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor with KRAS mutation identified.
✓. Expected survival time ≥12 weeks.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Must have at least one measureable lesion per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
✓. Have documented disease progression or intolerance after first-line treatment.

Exclusion criteria

✕. Gastrointestinal (GI) tract disease causing the inability to take oral medication.
✕. Previous accept with KRAS G12C inhibitor.
✕. Uncontrollable general infection.
✕. Serious cardiovascular disease.
✕. Left ventricular ejection fraction (LVEF) \<50 %.
✕. Known history of hypersensitivity to any of the excipients of GH35 tablets
✕. Pregnant or nursing (lactating) women.

What they're measuring

Dose-limiting toxicities (DLT)

Timeframe: 24 Days

Trial details

NCT IDNCT05010694

SponsorSuzhou Genhouse Bio Co., Ltd.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-22

View on ClinicalTrials.gov More Advanced Solid Tumors Harboring With G12C Mutation trials