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

• Sponsor: Suzhou Genhouse Bio Co., Ltd. (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05183243
• Collaborator: (none)
• Enrollment: 68
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 36
• Patients Per Site: 22.7
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor; Non-small Cell Carcinoma; Pancreatic Cancer; Colorectal Cancer; Head and Neck Tumor	Drug: GH21 Capsule	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 68 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Feb 20, 2022
• Anticipated Primary Completion Date: Feb 20, 2024
• Anticipated Study Completion Date: Feb 20, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Determination of Maximum Tolerated Dose (MTD) of GH21. [28 Days]

2. Characterize the safety of GH21 in subjects [Approximately 3 years]

   Number of participants with treatment-emergent adverse events and serious AEs.

Secondary Outcome Measures

1. Objective response rate (ORR) [Approximately 3 years]

   Based on assessment of radiographic imaging per RECIST version 1.1

2. Disease control rate (DCR) [Approximately 3 years]

   Based on assessment of radiographic imaging per RECIST version 1.1

3. Duration of response (DOR) [Approximately 3 years]

   Based on assessment of radiographic imaging per RECIST version 1.1

4. Progression-free survival (PFS) [Approximately 3 years]

   Based on assessment of radiographic imaging per RECIST version 1.1

5. Evaluate the pharmacokinetics of GH21 [Approximately 3 years]

   Blood plasma concentration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing University Cancer Hospital	Beijing	Beijing	China	100143
2	Chongqing Cancer Hospital	Chongqing		China
3	The First Affiliated Hospital of Zhejiang University	Zhejiang		China

Sponsors and Collaborators

• Suzhou Genhouse Bio Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Suzhou Genhouse Bio Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05183243
• Other Study ID Numbers: GH21-CRS001
• First Posted: Jan 10, 2022
• Last Update Posted: Feb 25, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Head and Neck Neoplasms

Study Results

No Results Posted as of Feb 25, 2022