Spots Global Cancer Trial Database for A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation
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Trial Identification
Brief Title: A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation
Official Title: A Phase 1, Open Label, Dose Escalation of HBI-2438 in Patients With Advanced Malignant Solid Tumors Harboring KRAS G12C Mutation
Study ID: NCT05485974
Interventions
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
California Cancer Associates for Research and Excellence, Inc. (cCare), Encinitas, California, United States
The Oncology Institute of Hope and Innovation, Glendale, California, United States
The Oncology Institute of Hope and Innovation, Long Beach, California, United States
The Oncology Institute of Hope and Innovation, Pasadena, California, United States
California Cancer Associates for Research and Excellence, Inc. (cCare), San Marcos, California, United States
The Oncology Institute of Hope and Innovation, Santa Ana, California, United States
Sarcoma Oncology, Santa Monica, California, United States
Innovative Clinical Research Institute (ICRI), Whittier, California, United States
The Oncology Institute of Hope and Innovation, Whittier, California, United States
BRCR Medical Center, Plantation, Florida, United States
Michigan Center of Medical Research, Farmington Hills, Michigan, United States
Alliance for Multispecialty Research, LLC, Kansas City, Missouri, United States
Gabrail Cancer Center, Canton, Ohio, United States
Pan American Center for Oncology Trials (PanOncology Trials), Rio Piedras, , Puerto Rico
Contact Details
Name: Alberto Bessudo, MD
Affiliation: California Cancer Associates for Research and Excellence, Inc. (cCare)
Role: PRINCIPAL_INVESTIGATOR
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