GH21 Capsules for Advanced Solid Tumors: A Study on Safet... | NCT05183243

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

NCT05183243

Sponsor

Suzhou Genhouse Bio Co., Ltd.

Status

Unknown status

Last Update Posted

Jul 16, 2024Actual

Enrollment

68Estimated

Phase

Phase 1

Conditions

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

Interventions

GH21 Capsule

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2022Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Feb 20, 2025Estimated

First Submitted Date

Dec 21, 2021

First Submission Date that Met QC Criteria

Dec 21, 2021

First Posted Date

Jan 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2024

Last Update Posted Date

Jul 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Monotherapy Dose Escalation.	Experimental	Treatment with GH21 alone, conducted until disease progression, intolerance or end of study.	Drug: GH21 Capsule

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GH21 Capsule	Drug	GH21 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F.	Monotherapy Dose Escalation.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determination of Maximum Tolerated Dose (MTD) of GH21.	MTD is the highest dose of a treatment that does not cause unacceptable side effects.	28 Days
Characterize the Safety of GH21	Number of participants with treatment-emergent adverse events and serious AEs.	Approximately 3 years

Secondary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR)	Based on assessment of radiographic imaging per RECIST version 1.1	Approximately 3 years
Disease Control Rate (DCR)	Based on assessment of radiographic imaging per RECIST version 1.1

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yiming Zhou, Bachelor	Contact	0521-86861608		zhouyiming@genhousebio.com

Overall Officials

Name	Affiliation	Role
Haidan Wang, Doctorate	0512-86861608	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Hospital of Anhui Medical University	Recruiting	Hefei	Anhui	230000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

NO plan

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D010190	Pancreatic Neoplasms
D015179	Colorectal Neoplasms
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided