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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05183243
• Other study ID #: GH21-CRS001
• Status: Recruiting
• Phase: Phase 1
• Start date: February 20, 2022
• Est. completion date: February 20, 2025

Study information

• Verified date: December 2023
• Source: Suzhou Genhouse Bio Co., Ltd.
• Contact: Yiming Zhou, Bachelor
• Phone: 0521-86861608
• Email: zhouyiming[@]genhousebio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: February 20, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Colorectal Cancer
• Head and Neck Neoplasms
• Head and Neck Tumor
• Neoplasms
• Non-small Cell Carcinoma
• Pancreatic Cancer

Intervention

Drug:
• GH21 Capsule
GH21 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F.

Locations

Country	Name	City	State
China	Beijing University Cancer Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing
China	Chongqing Cancer Hospital	Chongqing	Chongqing
China	The First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	Taizhou Hospital of Zhejiang Province	Linhai	Zhejiang
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Genhouse Bio Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of Maximum Tolerated Dose (MTD) of GH21.		28 Days
Primary	Characterize the safety of GH21 in subjects	Number of participants with treatment-emergent adverse events and serious AEs.	Approximately 3 years
Secondary	Objective response rate (ORR)	Based on assessment of radiographic imaging per RECIST version 1.1	Approximately 3 years
Secondary	Disease control rate (DCR)	Based on assessment of radiographic imaging per RECIST version 1.1	Approximately 3 years
Secondary	Duration of response (DOR)	Based on assessment of radiographic imaging per RECIST version 1.1	Approximately 3 years
Secondary	Progression-free survival (PFS)	Based on assessment of radiographic imaging per RECIST version 1.1	Approximately 3 years
Secondary	Evaluate the pharmacokinetics of GH21	Blood plasma concentration	Approximately 3 years