GH35 Tablets for Advanced Solid Tumors: A Study on Safety... | NCT05010694

Studies
GH35 Tablets for Advanced Solid Tumors: A Study on Safety and Early Results

NCT05010694

Sponsor

Suzhou Genhouse Bio Co., Ltd.

Status

Unknown status

Last Update Posted

Jul 8, 2024Actual

Enrollment

18Actual

Phase

Phase 1

Conditions

Advanced Solid Tumors Harboring With G12C Mutation

Interventions

GH35 Tablet

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

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 27, 2021Actual

Primary Completion Date

Mar 22, 2023Actual

Completion Date

Dec 12, 2025Estimated

First Submitted Date

Aug 11, 2021

First Submission Date that Met QC Criteria

Aug 11, 2021

First Posted Date

Aug 18, 2021Actual

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 4, 2024

Last Update Posted Date

Jul 8, 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 GH35 in patients with KRAS mutant advanced solid tumors.

Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in patients with KRAS mutant 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

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Monotherapy Dose Escalation.	Experimental	Treatment with GH35 alone, conducted until disease progression, intolerance or end of study.	Drug: GH35 Tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GH35 Tablet	Drug	GH35 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
Dose-limiting toxicities (DLT)	Number of participants with dose limiting toxicities (DLTs)	24 Days

Secondary Outcomes

Measure	Description	Time Frame
Characterize the safety of GH35 in subjects	Number of participants with treatment-emergent adverse events	30 Months
Pharmacokinetics of GH35	Blood plasma concentration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female subjects greater than or equal to 18 years old.
Histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor with KRAS mutation identified.
Expected survival time ≥12 weeks.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Must have at least one measureable lesion per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
Have documented disease progression or intolerance after first-line treatment.

Exclusion Criteria:

Gastrointestinal (GI) tract disease causing the inability to take oral medication.
Previous accept with KRAS G12C inhibitor.
Uncontrollable general infection.
Serious cardiovascular disease.
Left ventricular ejection fraction (LVEF) <50 %.
Known history of hypersensitivity to any of the excipients of GH35 tablets
Pregnant or nursing (lactating) women.

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

Not provided

Overall Officials

Name	Affiliation	Role
Baohui Han, Professor	Shanghai Chest Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Zhongshan Hospital		Shanghai	Shanghai Municipality		China
Shanghai Chest Hospital

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