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

NCT ID: NCT05485974

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

Conditions: Official terms:
Lung Neoplasms
Pancreatic Neoplasms

Conditions: Keywords:
KRAS G12C
FIH

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Intervention model description: 3+3 Dose Escalation Design with Expansion

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: HBI-2438
Description: KRAS G12C Inhibitor
Arm group label: Dose Escalation and Expansion

Summary: 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.

Detailed description: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: Key Inclusion Criteria: Male or female at least 18 years of age at the time of signing the ICF prior to initiation of any study specific activities/procedures Advanced malignant solid tumors with KRAS G12C mutation- as determined by genetic testing Must have failed or refused standard of care therapy, are not eligible for standard of care therapy, or cannot benefit from standard of care therapy, in the opinion of the Investigator At least 1 measurable target lesion that meets the definition of RECIST v1.1 ECOG Performance Status of 0 or 1 Demonstrate adequate organ function Expected survival time > 3 months in the opinion of the investigator Must be able to swallow oral medications and must not have gastrointestinal abnormalities that significantly affect drug absorption Exclusion Criteria: Key Exclusion Criteria: History of another concurrent malignancy within 3 years prior to study entry, unless the malignancy was treated with curative intent and the likelihood of relapse is <5% in 2 years Note: Subjects with a history of squamous or basal cell carcinoma of the skin or carcinoma in the situ of the cervix may be enrolled Untreated or symptomatic central nervous system (CNS) metastases Note: Subjects with asymptomatic treated CNS metastases are eligible provided they have been clinically stable and not requiring steroids for at least 4 weeks Clinically significant cardiovascular disease, including stroke or myocardial infarction within 6 months prior to first dose of HBI-2438; or the presence of unstable angina or congestive heart failure of New York Heart Association Grade 2 or higher Any unresolved Grade 2 or greater toxicity from previous anti-cancer therapy, except alopecia, within 4 weeks of first study treatment administration Active autoimmune diseases or history of autoimmune diseases that may relapse Pregnant or nursing Prior treatment with any KRAS G12C inhibitors Any condition that required systemic treatment with either corticosteroids (>10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤14 days before the first study treatment administration Treatment with other investigational drugs/devices within 4 weeks prior to first study treatment administration

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: California Cancer Associates for Research and Excellence, Inc. (cCare)

Address:
City: Encinitas
Zip: 92024
Country: United States

Status: Recruiting

Contact:
Last name: Christina Spencer

Phone: 760-452-3909
Email: cspencer@ccare.com

Investigator:
Last name: Alberto Bessudo, MD
Email: Principal Investigator

Facility:
Name: The Oncology Institute of Hope and Innovation

Address:
City: Glendale
Zip: 91204
Country: United States

Status: Recruiting

Contact:
Last name: Leslie Posadas

Phone: 562-693-4477
Email: lposadas@icrinstitute.com

Investigator:
Last name: Amitabha Mazumder, MD
Email: Principal Investigator

Facility:
Name: The Oncology Institute of Hope and Innovation

Address:
City: Long Beach
Zip: 90805
Country: United States

Status: Recruiting

Contact:
Last name: Leslie Posadas

Phone: 562-693-4477
Email: lposadas@icrinstitute.com

Investigator:
Last name: Amitabha Mazumder, MD
Email: Principal Investigator

Facility:
Name: The Oncology Institute of Hope and Innovation

Address:
City: Pasadena
Zip: 91105
Country: United States

Status: Recruiting

Contact:
Last name: Leslie Posadas

Phone: 562-693-4477
Email: lposadas@icrinstitute.com

Investigator:
Last name: Amitabha Mazumder, MD
Email: Principal Investigator

Facility:
Name: California Cancer Associates for Research and Excellence, Inc. (cCare)

Address:
City: San Marcos
Zip: 92069
Country: United States

Status: Recruiting

Contact:
Last name: Christina Spencer

Phone: 760-452-3909
Email: cspencer@ccare.com

Investigator:
Last name: Alberto Bessudo, MD
Email: Principal Investigator

Facility:
Name: The Oncology Institute of Hope and Innovation

Address:
City: Santa Ana
Zip: 92705
Country: United States

Status: Recruiting

Contact:
Last name: Leslie Posadas

Phone: 562-693-4477
Email: lposadas@icrinstitute.com

Investigator:
Last name: Amitabha Mazumder, MD
Email: Principal Investigator

Facility:
Name: Sarcoma Oncology

Address:
City: Santa Monica
Zip: 90403
Country: United States

Status: Not yet recruiting

Contact:
Last name: Victoria S Chua-Alcala, MD, CLS

Phone: 310-552-9999
Email: vchua@sarcomaoncology.com

Investigator:
Last name: Sant Chawla, MD
Email: Principal Investigator

Facility:
Name: Innovative Clinical Research Institute (ICRI)

Address:
City: Whittier
Zip: 90603
Country: United States

Status: Recruiting

Contact:
Last name: Leslie Posadas

Phone: 562-693-4477
Email: lposadas@icrinstitute.com

Investigator:
Last name: Amitabha Mazumder, MD
Email: Principal Investigator

Facility:
Name: The Oncology Institute of Hope and Innovation

Address:
City: Whittier
Zip: 90603
Country: United States

Status: Recruiting

Contact:
Last name: Leslie Posadas

Phone: 562-693-4477
Email: lposadas@icrinstitute.com

Investigator:
Last name: Amitabha Mazumder, MD
Email: Principal Investigator

Facility:
Name: BRCR Medical Center

Address:
City: Plantation
Zip: 33322
Country: United States

Status: Not yet recruiting

Contact:
Last name: Ines Padron

Phone: 561-447-0614

Phone ext: 102
Email: ipadron@brcrglobal.com

Investigator:
Last name: Harshad Amin, MD
Email: Principal Investigator

Facility:
Name: Michigan Center of Medical Research

Address:
City: Farmington Hills
Zip: 48334
Country: United States

Status: Recruiting

Contact:
Last name: Rameez Umer

Phone: 248-747-4383
Email: rameez.umer@michmer.com

Investigator:
Last name: Richard P Zekman, DO
Email: Principal Investigator

Facility:
Name: Alliance for Multispecialty Research, LLC

Address:
City: Kansas City
Zip: 64114
Country: United States

Status: Recruiting

Contact:
Last name: Jennifer Ross

Phone: 816-943-0770
Email: jennifer.ross@amrllc.com

Investigator:
Last name: Jaswinder Singh, MD
Email: Principal Investigator

Facility:
Name: Gabrail Cancer Center

Address:
City: Canton
Zip: 44718
Country: United States

Status: Recruiting

Contact:
Last name: Kim Roby

Phone: 330-492-3345

Phone ext: 227
Email: kroby@gabrailcancercenter.com

Investigator:
Last name: Nashat Gabrail, MD
Email: Principal Investigator

Facility:
Name: Pan American Center for Oncology Trials (PanOncology Trials)

Address:
City: Rio Piedras
Zip: 00935
Country: Puerto Rico

Status: Recruiting

Contact:
Last name: Maria R Cruz-Correa, MD,PhD,AGAF,FASGE

Phone: 787-407-3333
Email: marcia.cruzcorrea@panoncologytrials.com

Investigator:
Last name: Marcia R Cruz-Correa, MD,PhD,AGAF,FASGE
Email: Principal Investigator

Start date: August 1, 2022

Completion date: August 2025

Lead sponsor:
Agency: HUYABIO International, LLC.
Agency class: Industry

Source: HUYABIO International, LLC.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05485974

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