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ACTIVE NOT RECRUITING
NCT05010694
PHASE1

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

Sponsor: Suzhou Genhouse Bio Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of GH35 Tablets in Patients Harboring With G12C Mutation in Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2021-09-27

Completion Date

2025-12-12

Last Updated

2024-07-08

Healthy Volunteers

No

Interventions

DRUG

GH35 Tablet

GH35 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F.

Locations (2)

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China