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

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label,Multi-center, -Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Primary Antitumor Activity of GH21 in Patients With Advanced Solid Tumors

Conditions
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Pancreatic Cancer, Colorectal Cancer, Advanced Solid Tumor, Non-small Cell Carcinoma, Head and Neck Tumor

Intervention / Treatment
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* Drug: GH21 Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monotherapy Dose Escalation.<br>Treatment with GH21 alone, conducted until disease progression, intolerance or end of study. | Drug: GH21 Capsule<br>* GH21 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of Maximum Tolerated Dose (MTD) of GH21. |  | 28 Days | 
| Characterize the safety of GH21 in subjects | Number of participants with treatment-emergent adverse events and serious AEs. | Approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | Based on assessment of radiographic imaging per RECIST version 1.1 | Approximately 3 years | 
| Disease control rate (DCR) | Based on assessment of radiographic imaging per RECIST version 1.1 | Approximately 3 years | 
| Duration of response (DOR) | Based on assessment of radiographic imaging per RECIST version 1.1 | Approximately 3 years | 
| Progression-free survival (PFS) | Based on assessment of radiographic imaging per RECIST version 1.1 | Approximately 3 years | 
| Evaluate the pharmacokinetics of GH21 | Blood plasma concentration | Approximately 3 years |