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Active Not RecruitingPhase 1NCT05485974
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedHBI-2438

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 24, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1

Interventional

Where is it offered?14 U.S. locations

Locations may change over time.

Who runs it?HUYABIO International, LLC.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
HUYABIO International, LLC.
Interventions being studied
Drug: HBI-2438
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Biomarkers
KRAS→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion criteria

Key

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • California Cancer Associates for Research and Excellence, Inc. (cCare)Encinitas, California
  • The Oncology Institute of Hope and InnovationGlendale, California
  • The Oncology Institute of Hope and InnovationLong Beach, California
  • The Oncology Institute of Hope and InnovationPasadena, California
  • California Cancer Associates for Research and Excellence, Inc. (cCare)San Marcos, California
  • The Oncology Institute of Hope and InnovationSanta Ana, California
  • Sarcoma OncologySanta Monica, California
  • Innovative Clinical Research Institute (ICRI)Whittier, California
  • The Oncology Institute of Hope and InnovationWhittier, California
  • BRCR Medical CenterPlantation, Florida
  • Michigan Center of Medical ResearchFarmington Hills, Michigan
  • Alliance for Multispecialty Research, LLCKansas City, Missouri

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 24, 2025. Always confirm current availability with the study team.

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