GH21 Capsules for Advanced Solid Tumors: A Study on Safety and Early Results

Phase 1

Recruiting

• Conditions: Non-Small Cell Lung Cancer; Colorectal Cancer; Advanced Solid Tumor; Pancreatic Cancer; Head and Neck Neoplasm
• Interventions: Drug: GH21 Capsule

• Registration Number: NCT05183243
• Lead Sponsor: Suzhou Genhouse Bio Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2021-12-21
• Study First Posted: 2022-01-10
• Study Start: 2022-02-20
• Status Verified: 2023-12
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-16
• Primary Completion: 2024-12-31
• Study Completion: 2025-02-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Monotherapy Dose Escalation.	GH21 Capsule	Treatment with GH21 alone, conducted until disease progression, intolerance or end of study.

Primary Outcome Measures

Name	Time	Method
Determination of Maximum Tolerated Dose (MTD) of GH21.	28 Days	MTD is the highest dose of a treatment that does not cause unacceptable side effects.
Characterize the Safety of GH21	Approximately 3 years	Number of participants with treatment-emergent adverse events and serious AEs.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Approximately 3 years	Based on assessment of radiographic imaging per RECIST version 1.1
Disease Control Rate (DCR)	Approximately 3 years	Based on assessment of radiographic imaging per RECIST version 1.1
Duration of Response (DOR)	Approximately 3 years	Based on assessment of radiographic imaging per RECIST version 1.1
Progression-Free Survival (PFS)	Approximately 3 years	Based on assessment of radiographic imaging per RECIST version 1.1
PD of GH21	Approximately 3 years	Change of phosphorylated ERK
Cmax	Approximately 3 years	The maximum or "peak" concentration of GH21 observed after administration
T1/2	Approximately 3 years	Half-life of GH21
Tmax	Approximately 3 years	The time to peak concentration of GH21

Trial Locations

Locations (9)

Cancer Hospital Chinese Academy of Medical Science; 🇨🇳 Beijing, Beijing, China

Beijing University Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China

Taizhou Hospital of Zhejiang Province; 🇨🇳 Linhai, Zhejiang, China

The Second Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Chongqing Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China

The First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China