Advanced Solid Tumor, Colorectal Cancer, Head and Neck Neoplasm, Non-Small Cell Lung Cancer, Pancreatic Cancer
Conditions
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.
Interventions
DRUGGH21 Capsule
GH21 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F.
Sponsors
Suzhou Genhouse Bio Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of Maximum Tolerated Dose (MTD) of GH21. | 28 Days | MTD is the highest dose of a treatment that does not cause unacceptable side effects. |
| Characterize the Safety of GH21 | Approximately 3 years | Number of participants with treatment-emergent adverse events and serious AEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) | Approximately 3 years | Based on assessment of radiographic imaging per RECIST version 1.1 |
| Progression-Free Survival (PFS) | Approximately 3 years | Based on assessment of radiographic imaging per RECIST version 1.1 |
| PD of GH21 | Approximately 3 years | Change of phosphorylated ERK |
| Objective Response Rate (ORR) | Approximately 3 years | Based on assessment of radiographic imaging per RECIST version 1.1 |
| Tmax | Approximately 3 years | The time to peak concentration of GH21 |
| T1/2 | Approximately 3 years | Half-life of GH21 |
| Cmax | Approximately 3 years | The maximum or peak concentration of GH21 observed after administration |
| Disease Control Rate (DCR) | Approximately 3 years | Based on assessment of radiographic imaging per RECIST version 1.1 |
Countries
China
Contacts
Primary ContactYiming Zhou, Bachelor
Outcome results
None listed