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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05010694

Enrollment

Registered

2021-08-18

Start date

2021-09-27

Completion date

2025-12-12

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors Harboring With G12C Mutation

Keywords

Advanced Solid Tumors, KRAS

Brief 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.

Interventions

DRUGGH35 Tablet

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male or female subjects greater than or equal to 18 years old. 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

1. Gastrointestinal (GI) tract disease causing the inability to take oral medication. 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.

Design outcomes

Primary

Measure	Time frame	Description
Dose-limiting toxicities (DLT)	24 Days	Number of participants with dose limiting toxicities (DLTs)

Secondary

Measure	Time frame	Description
Pharmacokinetics of GH35	1 Month	Blood plasma concentration
Objective response rate (ORR) as defined by RECIST 1.1 criteria	30 Months	—
Characterize the safety of GH35 in subjects	30 Months	Number of participants with treatment-emergent adverse events
Progression-free survival (PFS) as defined by RECIST 1.1 criteria	30 Months	—
Disease control rate (DCR) as defined by RECIST 1.1 criteria	30 Months	—
Duration of response (DOR) as defined by RECIST 1.1 criteria	30 Months	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026