Dose Finding Study of GH35 in Patients With Advanced Solid Tumors

A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Primary Antitumor Activity of GH35 in Patients With Advanced Solid Tumors With KRAS Mutation

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: Recruiting
• Conditions: AdvAdvanced Solid Tumors; Kirsten Rat Sarcoma
• Intervention / Treatment: Drug: GH35 Tablet

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Project Manager; Phone Number: 0512-86861608; Email: zhouyiming@genhousebio.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Baohui Han, Professor; Phone Number: +8621-222-00000; Email: hanxkyy@aliyun.com
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • Fudan University Zhongshan Hospital
      • Contact: Tianshu Liu, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	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	Number of participants with treatment-emergent adverse events	30 Months
Evaluate the pharmacokinetics of GH35	Blood plasma concentration	1 Month
Objective response rate (ORR) as assessed by RECIST 1.1 criteria		30 Months
Duration of response (DOR) as assessed by RECIST 1.1 criteria		30 Months
Progression-free survival (PFS) as assessed by RECIST 1.1 criteria		30 Months
Disease control rate (DCR) as assessed by RECIST 1.1 criteria		30 Months

Collaborators and Investigators

• Sponsor: Suzhou Genhouse Bio Co., Ltd.
• Investigators: Principal Investigator: Baohui Han, Professor, Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Anticipated): December 12, 2023
• Study Completion (Anticipated): 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): December 20, 2021
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Advanced Solid Tumors, KRAS
• Additional Relevant MeSH Terms: Neoplasms
• 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