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

• Status: Not yet recruiting
• Trial end date: 2025-02-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzhou Genhouse Bio Co., Ltd.

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.