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

Launched by SUZHOU GENHOUSE BIO CO., LTD. · Dec 21, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called GH21, which is being tested for its safety and how well it might work in patients with advanced solid tumors, including types like non-small cell lung cancer, pancreatic cancer, colorectal cancer, and head and neck cancer. The main goal is to find the highest dose of GH21 that patients can tolerate without serious side effects.

To be eligible for this study, participants need to be at least 18 years old and have a confirmed diagnosis of an advanced or metastatic solid tumor. They should be in relatively good health, meaning they can perform everyday activities with only minor limitations. Participants will be monitored closely throughout the trial to ensure their safety and to gather information on how the treatment affects their tumors. It's important to note that certain health conditions, such as recent major surgeries or specific infections, may prevent someone from joining the trial. If you or a loved one is considering participation, you will need to give your written consent before starting any study-related procedures.

Gender

ALL

Eligibility criteria

• 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.