GH35 Tablets for Advanced Solid Tumors: A Study on Safety and Early Results
NCT ID: NCT05010694
Last Updated: 2024-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
18 participants
INTERVENTIONAL
2021-09-27
2025-12-12
Brief Summary
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Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in patients with KRAS mutant advanced solid tumors.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Monotherapy Dose Escalation.
Treatment with GH35 alone, conducted until disease progression, intolerance or end of study.
GH35 Tablet
GH35 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F.
Interventions
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GH35 Tablet
GH35 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F.
Eligibility Criteria
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Inclusion Criteria
2. Histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor with KRAS mutation identified.
3. Expected survival time ≥12 weeks.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Must have at least one measureable lesion per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
6. Have documented disease progression or intolerance after first-line treatment.
Exclusion Criteria
2. Previous accept with KRAS G12C inhibitor.
3. Uncontrollable general infection.
4. Serious cardiovascular disease.
5. Left ventricular ejection fraction (LVEF) \<50 %.
6. Known history of hypersensitivity to any of the excipients of GH35 tablets
7. Pregnant or nursing (lactating) women.
18 Years
ALL
No
Sponsors
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Suzhou Genhouse Bio Co., Ltd.
OTHER
Responsible Party
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Principal Investigators
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Baohui Han, Professor
Role: PRINCIPAL_INVESTIGATOR
Shanghai Chest Hospital
Locations
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Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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GH35-CRS001
Identifier Type: -
Identifier Source: org_study_id
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