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