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

Phase 1

Active, not recruiting

• Conditions: Advanced Solid Tumors Harboring With G12C Mutation
• Interventions: Drug: GH35 Tablet

• Registration Number: NCT05010694
• Lead Sponsor: Suzhou Genhouse Bio Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-11
• Study First Submitted QC: 2021-08-11
• Study First Posted: 2021-08-18
• Study Start: 2021-09-27
• Primary Completion: 2023-03-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08
• Study Completion: 2025-12-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Monotherapy Dose Escalation.	GH35 Tablet	Treatment with GH35 alone, conducted until disease progression, intolerance or end of study.

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicities (DLT)	24 Days	Number of participants with dose limiting toxicities (DLTs)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of GH35	1 Month	Blood plasma concentration
Objective response rate (ORR) as defined by RECIST 1.1 criteria	30 Months
Duration of response (DOR) as defined by RECIST 1.1 criteria	30 Months
Progression-free survival (PFS) 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
Disease control rate (DCR) as defined by RECIST 1.1 criteria	30 Months

Trial Locations

Locations (2)

Fudan University Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China