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

July 4, 2024 updated by: Suzhou Genhouse Bio Co., Ltd.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai Chest Hospital
      • Shanghai, Shanghai, China
        • Fudan University Zhongshan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Monotherapy Dose Escalation.
Treatment with GH35 alone, conducted until disease progression, intolerance or end of study.
Drug: GH35 Tablet
GH35 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Genhouse Bio Co., Ltd.

Investigators

  • Principal Investigator: Baohui Han, Professor, Shanghai Chest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2021

Primary Completion (Actual)

March 22, 2023

Study Completion (Estimated)

December 12, 2025

Study Registration Dates

First Submitted

August 11, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

July 4, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GH35-CRS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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