Clinical trialNCT05485974Active, not recruitingPhase 1Interventional

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

SponsorHUYABIO International, LLC.Enrollment44CancerCancer of PancreasColon CancerColorectal CancerLung CancerNon Small Cell Lung Cancer+1 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Alberto Bessudo, MD
California Cancer Associates for Research and Excellence, Inc. (cCare)
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

14 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico

Pan American Center for Oncology Trials (panoncology Trials)
Rio Piedras, Puerto Rico, Puerto Rico

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

HBI-2438

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Aug 2022
Primary completion: 31 Dec 2026
Completion: 31 Dec 2026
Last update posted: 24 Sept 2025
Registered enrollment: 44
Registry id: NCT05485974

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.