Clinical trial NCT05183243: GH21 Capsules for Advanced Solid Tumors: A Study on Safety and Early Results
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Non-Small Cell Lung Cancer
Pancreatic Cancer
Colorectal Cancer
Head and Neck Neoplasm
Lead sponsor: Suzhou Genhouse Bio Co., Ltd.
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Determination of Maximum Tolerated Dose (MTD) of GH21.
timeFrame: 28 Days
measure: Characterize the Safety of GH21
timeFrame: Approximately 3 years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Approximately 3 years
measure: Disease Control Rate (DCR)
timeFrame: Approximately 3 years
measure: Duration of Response (DOR)
timeFrame: Approximately 3 years
measure: Progression-Free Survival (PFS)
timeFrame: Approximately 3 years
measure: PD of GH21
timeFrame: Approximately 3 years
measure: Cmax
timeFrame: Approximately 3 years
measure: Tmax
timeFrame: Approximately 3 years
measure: T1/2
timeFrame: Approximately 3 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science
state: Beijing
city: Beijing
country: China
facility: Beijing University Cancer Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
Study officials:
affiliation: 0512-86861608
name: Haidan Wang, Doctorate
role: STUDY_DIRECTOR
References: