A Multicenter, Open-label Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of GH21 Capsules in Subjects With Advanced Solid Tumors

Trial ID: NCT05183243

Interventional - Phase 1 - Unknown status

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.

Conditions

• Advanced Solid Tumor
• Non-Small Cell Lung Cancer
• Pancreatic Cancer
• Colorectal Cancer
• Head and Neck Neoplasm

Interventions

• GH21 Capsule

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.

Sponsor

Suzhou Genhouse Bio Co., Ltd.

Source: ClinicalTrials.gov

Search more clinical trials on myTomorrows