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

Suzhou Genhouse Bio

Status and phase: Active, not recruiting; Phase 1

Conditions: Advanced Solid Tumors Harboring With G12C Mutation

Treatments: Drug: GH35 Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05010694

GH35-CRS001

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Monotherapy Dose Escalation.

Experimental group

Description:

Treatment with GH35 alone, conducted until disease progression, intolerance or end of study.

Treatment:

Drug: GH35 Tablet