Dose Finding Study of GH21 in Adult Patients With Advanced Solid Tumors

An Open-label,Multi-center, -Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Primary Antitumor Activity of GH21 in Patients With Advanced Solid Tumors

Evaluate the safety and tolerability of GH21 in patients with advanced solid tumors.

Estimate the maximum tolerated dose (MTD) in patients with advanced solid tumors.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Pancreatic Cancer; Advanced Solid Tumor; Non-small Cell Carcinoma; Head and Neck Tumor
• Intervention / Treatment: Drug: GH21 Capsule

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yiming Zhou, Bachelor; Phone Number: 0521-86861608; Email: zhouyiming@genhousebio.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Recruiting
      • The Second Hospital of Anhui Medical University
      • Contact: Mingjun Zhang, Master; Phone Number: （86）0551-63869529; Email: mjzhang2010@outlook.com
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Science
      • Contact: Ning Li, Postdoctoral; Phone Number: （86）010-87788495; Email: lining@cicams.ac.cn
    • Beijing, Beijing, China, 100143
      • Recruiting
      • Beijing University Cancer Hospital
      • Contact: Lin Shen, Doctorate; Phone Number: （86）010-88121122; Email: doctorshenlin@sina.cn
  • Chongqing
    • Chongqing, Chongqing, China
      • Recruiting
      • Chongqing Cancer Hospital
      • Contact: Yongsheng Li, Doctorate; Phone Number: （86）023-65301682; Email: lys@cqu.edu.cn
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Suxia Luo, Doctorate; Phone Number: （86）0371-65588251; Email: luosxrm@163.com
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
      • Contact: Xingya Li, Doctorate; Phone Number: （86） 0371-67966263; Email: lixingyavip@163.com
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Nanjing Drum Tower hospital
      • Contact: Yongsheng Wang, Doctorate; Phone Number: （86）025-83304616; Email: dolphin8012@yahoo.com
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The First Affiliated Hospital of Zhejiang University
      • Contact: Haiping Jiang, Doctorate; Phone Number: （86）0571-87236685; Email: Jianghaiping75@163.com
    • Linhai, Zhejiang, China, 317099
      • Recruiting
      • Taizhou Hospital of Zhejiang Province
      • Contact: Jianying Jin, Master; Phone Number: （86）0576-85120120; Email: 302861459@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 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. Written informed consent obtained prior to any study-related procedure being performed;
3. Subjects with life expectancy ≥3 months;
4. Eastern Cooperative Oncology Group performance score 0 - 2;
5. Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor;
6. At least one measurable lesion based on RECIST version 1.1 .

Exclusion Criteria:

1. History of other malignancies within 3 years before screening,unless radical non-melanoma skin cancer or basal cell carcinoma of the skin or carcinoma in the situ of the cervix;
2. Have central nervous system metastases;
3. Prior treatment with SHP2 inhibitor;
4. Have major surgery within 28 days prior to the first dose of GH21;
5. Left ventricular ejection fraction (LVEF) <50 %;
6. Females who are pregnant or breastfeeding ;
7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
8. Conditions that the investigator considers inappropriate for participation in this clinical trial.

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 GH21 alone, conducted until disease progression, intolerance or end of study.	Drug: GH21 Capsule; GH21 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
Determination of Maximum Tolerated Dose (MTD) of GH21.		28 Days
Characterize the safety of GH21 in subjects	Number of participants with treatment-emergent adverse events and serious AEs.	Approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	Based on assessment of radiographic imaging per RECIST version 1.1	Approximately 3 years
Disease control rate (DCR)	Based on assessment of radiographic imaging per RECIST version 1.1	Approximately 3 years
Duration of response (DOR)	Based on assessment of radiographic imaging per RECIST version 1.1	Approximately 3 years
Progression-free survival (PFS)	Based on assessment of radiographic imaging per RECIST version 1.1	Approximately 3 years
Evaluate the pharmacokinetics of GH21	Blood plasma concentration	Approximately 3 years

Collaborators and Investigators

• Sponsor: Suzhou Genhouse Bio Co., Ltd.
• Investigators: Study Director: Haidan Wang, Doctorate, 0512-86861608

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): February 20, 2025

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: GH21-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