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

Primary Purpose

Advanced Solid Tumor, Non-small Cell Carcinoma, Pancreatic Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
GH21 Capsule
Sponsored by
Suzhou Genhouse Bio Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beijing University Cancer Hospital
  • Chongqing Cancer Hospital
  • The First Affiliated Hospital of Zhejiang University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Monotherapy Dose Escalation.

Arm Description

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

Outcomes

Primary Outcome Measures

Determination of Maximum Tolerated Dose (MTD) of GH21.
Characterize the safety of GH21 in subjects
Number of participants with treatment-emergent adverse events and serious AEs.

Secondary Outcome Measures

Objective response rate (ORR)
Based on assessment of radiographic imaging per RECIST version 1.1
Disease control rate (DCR)
Based on assessment of radiographic imaging per RECIST version 1.1
Duration of response (DOR)
Based on assessment of radiographic imaging per RECIST version 1.1
Progression-free survival (PFS)
Based on assessment of radiographic imaging per RECIST version 1.1
Evaluate the pharmacokinetics of GH21
Blood plasma concentration

Full Information

First Posted
December 21, 2021
Last Updated
February 9, 2022
Sponsor
Suzhou Genhouse Bio Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05183243
Brief Title
Dose Finding Study of GH21 in Adult Patients With Advanced Solid Tumors
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 20, 2022 (Anticipated)
Primary Completion Date
February 20, 2024 (Anticipated)
Study Completion Date
February 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Genhouse Bio Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor, Non-small Cell Carcinoma, Pancreatic Cancer, Colorectal Cancer, Head and Neck Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monotherapy Dose Escalation.
Arm Type
Experimental
Arm Description
Treatment with GH21 alone, conducted until disease progression, intolerance or end of study.
Intervention Type
Drug
Intervention Name(s)
GH21 Capsule
Intervention Description
GH21 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F.
Primary Outcome Measure Information:
Title
Determination of Maximum Tolerated Dose (MTD) of GH21.
Time Frame
28 Days
Title
Characterize the safety of GH21 in subjects
Description
Number of participants with treatment-emergent adverse events and serious AEs.
Time Frame
Approximately 3 years
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Based on assessment of radiographic imaging per RECIST version 1.1
Time Frame
Approximately 3 years
Title
Disease control rate (DCR)
Description
Based on assessment of radiographic imaging per RECIST version 1.1
Time Frame
Approximately 3 years
Title
Duration of response (DOR)
Description
Based on assessment of radiographic imaging per RECIST version 1.1
Time Frame
Approximately 3 years
Title
Progression-free survival (PFS)
Description
Based on assessment of radiographic imaging per RECIST version 1.1
Time Frame
Approximately 3 years
Title
Evaluate the pharmacokinetics of GH21
Description
Blood plasma concentration
Time Frame
Approximately 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yiming Zhou, project Manager
Phone
0521-86861608
Email
zhouyiming@genhousebio.com
Facility Information:
Facility Name
Beijing University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100143
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Shen, professor
Phone
010-88121122
Email
doctorshenlin@sina.cn
Facility Name
Chongqing Cancer Hospital
City
Chongqing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongsheng Li, Professor
Email
lys@cqu.edu.cn
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiping Jiang, professor

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
NO plan

Learn more about this trial

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

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