Status:
UNKNOWN
GH21 Capsules for Advanced Solid Tumors: A Study on Safety and Early Results
Lead Sponsor:
Suzhou Genhouse Bio Co., Ltd.
Conditions:
Advanced Solid Tumor
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Male or female subjects greater than or equal to 18 years old；
- Written informed consent obtained prior to any study-related procedure being performed;
- Subjects with life expectancy ≥3 months;
- Eastern Cooperative Oncology Group performance score 0 - 2;
- Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor;
- At least one measurable lesion based on RECIST version 1.1 .
Exclusion
- 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;
- Have central nervous system metastases;
- Prior treatment with SHP2 inhibitor;
- Have major surgery within 28 days prior to the first dose of GH21;
- Left ventricular ejection fraction (LVEF) \<50 %;
- Females who are pregnant or breastfeeding ;
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
- Conditions that the investigator considers inappropriate for participation in this clinical trial.
Key Trial Info
Start Date :
February 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 20 2025
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT05183243
Start Date
February 20 2022
End Date
February 20 2025
Last Update
July 16 2024
Active Locations (9)
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1
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
2
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China, 100021
3
Beijing University Cancer Hospital
Beijing, Beijing Municipality, China, 100143
4
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China