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

NCT05010694 | Active Not Recruiting Phase 1

• 1 other identifier: GH35-CRS001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Solid Tumors Harboring With G12C Mutation

Keywords

Advanced Solid Tumors, KRAS

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicities (DLT)

  Number of participants with dose limiting toxicities (DLTs)

  24 Days

Secondary Outcomes (6)

• Characterize the safety of GH35 in subjects

  30 Months

• Pharmacokinetics of GH35

  1 Month

• 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

Study Arms (1)

Monotherapy Dose Escalation.

EXPERIMENTAL

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

Drug: GH35 Tablet

Interventions

GH35 Tablet DRUG

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

Monotherapy Dose Escalation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects greater than or equal to 18 years old.
• Histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor with KRAS mutation identified.
• Expected survival time ≥12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Must have at least one measureable lesion per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
• Have documented disease progression or intolerance after first-line treatment.

You may not qualify if:

• Gastrointestinal (GI) tract disease causing the inability to take oral medication.
• Previous accept with KRAS G12C inhibitor.
• Uncontrollable general infection.
• Serious cardiovascular disease.
• Left ventricular ejection fraction (LVEF) \<50 %.
• Known history of hypersensitivity to any of the excipients of GH35 tablets
• Pregnant or nursing (lactating) women.

Sponsors & Collaborators

• Suzhou Genhouse Bio Co., Ltd.: lead

Study Sites (2)

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Location

Study Officials

• Baohui Han, Professor

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 18, 2021
• Study Start: September 27, 2021
• Primary Completion: March 22, 2023
• Study Completion: December 12, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)