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

Suzhou Genhouse Bio

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumor; Head and Neck Neoplasm; Non-Small Cell Lung Cancer; Colorectal Cancer; Pancreatic Cancer

Treatments: Drug: GH21 Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT05183243

GH21-CRS001

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 1 patient group

Monotherapy Dose Escalation.

Experimental group

Description:

Treatment with GH21 alone, conducted until disease progression, intolerance or end of study.

Treatment:

Drug: GH21 Capsule