A Dose Escalation Study Of HBI-2438 In Patients With Solid Tumors Harboring KRAS G12C Mutation

Study Overview

A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation

A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS G12C mutation to determine the maximum tolerated dose and recommended Phase II dose of HBI-2438 and characterize its pharmacokinetic profile.

A Phase 1, Open-Label, Dose Escalation of HBI-2438 in Patients with Advanced Malignant Solid Tumors Harboring KRAS G12C Mutation. The primary and secondary objectives are: 1. To determine the MTD and recommended Phase 2 dose (RP2D) of HBI-2438 as an oral monotherapy for advanced solid tumors harboring KRAS G12C mutation. 2. To characterize the PK of HBI-2438 in subjects with advanced malignant solid tumors harboring KRAS G12C mutation. HBI-2438 is an orally administered KRAS G12C Inhibitor and will be dosed once daily throughout the escalation and expansion phase. Up to 44 subjects will be enrolled sequentially into the 3+3 dose escalation and monitored throughout the study for safety and tolerability. The dose escalation phase will consist of 6 cohorts, with doses ranging from 150 to 1200mg. Once the MTD of RP2D is established, an additional 6-8 subjects with brain metastases will be enrolled into the expansion phase at that dose level.

Lung Cancer
Non Small Cell Lung Cancer
Colorectal Cancer
Cancer of Pancreas
Colon Cancer
Solid Tumor
Cancer

DRUG: HBI-2438

HBI-2438-101

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-08-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-09-12
First Submitted that Met QC Criteria 2022-08-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-09-13
First Posted (ACTUAL) 2022-08-03	Results First Posted N/A	Last Verified 2023-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Dose Escalation and Expansion HBI-2438 will be given orally in ascending doses (escalation cohort), until the maximum tolerated dose or recommended Phase 2 dose is reached. Up to 6-8 patients will then be enrolled in the expansion cohort at the recommended dose.	DRUG: HBI-2438 KRAS G12C Inhibitor

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Dose Escalation and Expansion

HBI-2438 will be given orally in ascending doses (escalation cohort), until the maximum tolerated dose or recommended Phase 2 dose is reached. Up to 6-8 patients will then be enrolled in the expansion cohort at the recommended dose.

DRUG: HBI-2438

KRAS G12C Inhibitor

Primary Outcome Measures	Measure Description	Time Frame
To determine the maximum tolerated dose (MTD)	Safety endpoints: Incidence of dose-limiting toxicities (DLTs)	Up to 36 months
adverse events (AEs), and serious adverse events (SAEs) overall	Safety endpoints: adverse events (AEs), and serious adverse events (SAEs) overall	Up to 36 months

Secondary Outcome Measures	Measure Description	Time Frame
maximum plasma concentration (Cmax)	Pharmacokinetic variables including maximum plasma concentration (Cmax)	Cycle 1 (21 days)
minimum plasma concentration (Cmin)	Pharmacokinetic variables including minimum plasma concentration (Cmin)	Cycle 1 (21 days)
Area Under the Curve (AUC)	Pharmacokinetic variables including Area Under the Curve (AUC)	Cycle 1 (21 days)
Pharmacokinetic variables including clearance	Pharmacokinetic variables including clearance	Cycle 1 (21 days)
Pharmacokinetic variables including serum half-life	Pharmacokinetic variables including serum half-life	Cycle 1 (21 days)
Pharmacokinetic variables including volume of distribution	Pharmacokinetic variables including volume of distribution	Cycle 1 (21 days)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: John Ning, MD,PhD,FAIC

Phone Number: 858-280-1866

Email: jning@huyabio.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Alberto Bessudo, MD, California Cancer Associates for Research and Excellence, Inc. (cCare)

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record