ACTIVE_NOT_RECRUITING

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

Talk to us

Conditions

Lung CancerNon Small Cell Lung CancerColorectal CancerCancer of PancreasColon CancerSolid TumorCancerKRAS G12CFIH

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1, Open Label, Dose Escalation of HBI-2438 in Patients With Advanced Malignant Solid Tumors Harboring KRAS G12C Mutation

Quick Facts

Study Start:2022-08-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05485974

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

California Cancer Associates for Research and Excellence, Inc. (cCare)
Encinitas, California, 92024
United States
The Oncology Institute of Hope and Innovation
Glendale, California, 91204
United States
The Oncology Institute of Hope and Innovation
Long Beach, California, 90805
United States
The Oncology Institute of Hope and Innovation
Pasadena, California, 91105
United States
California Cancer Associates for Research and Excellence, Inc. (cCare)
San Marcos, California, 92069
United States
The Oncology Institute of Hope and Innovation
Santa Ana, California, 92705
United States
Sarcoma Oncology
Santa Monica, California, 90403
United States
Innovative Clinical Research Institute (ICRI)
Whittier, California, 90603
United States
The Oncology Institute of Hope and Innovation
Whittier, California, 90603
United States
BRCR Medical Center
Plantation, Florida, 33322
United States
Michigan Center of Medical Research
Farmington Hills, Michigan, 48334
United States
Alliance for Multispecialty Research, LLC
Kansas City, Missouri, 64114
United States
Gabrail Cancer Center
Canton, Ohio, 44718
United States

Collaborators and Investigators

Sponsor: HUYABIO International, LLC.

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

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

Study Start Date2022-08-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-08-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • KRAS G12C
  • FIH

Additional Relevant MeSH Terms

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