Trials / Active Not Recruiting
Active Not RecruitingNCT05010694
GH35 Tablets for Advanced Solid Tumors: A Study on Safety and Early Results
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
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Suzhou Genhouse Bio Co., Ltd. · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GH35 Tablet | GH35 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F. |
Timeline
- Start date
- 2021-09-27
- Primary completion
- 2023-03-22
- Completion
- 2025-12-12
- First posted
- 2021-08-18
- Last updated
- 2024-07-08
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05010694. Inclusion in this directory is not an endorsement.