Home › Trials › NCT05485974

Testing HBI-2438 in patients with solid tumors that have a KRAS G12C mutation

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

Phase 1 Interventional HUYABIO International, LLC. · NCT05485974

This study is testing a new oral medication called HBI-2438 to see if it is safe and effective for people with advanced solid tumors that have a specific KRAS G12C mutation.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment44 (estimated)
Ages18 Years and up
SexAll
SponsorHUYABIO International, LLC. Industry-sponsored
Drugs / interventionsprednisone
Locations14 sites (Encinitas, California and 13 other locations)
Trial IDNCT05485974 on ClinicalTrials.gov

What this trial studies

This Phase 1, open-label dose escalation study aims to evaluate the safety and tolerability of HBI-2438, an oral KRAS G12C inhibitor, in patients with advanced solid tumors harboring the KRAS G12C mutation. The study will determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) through a 3+3 dose escalation design, enrolling up to 44 subjects. Participants will be monitored for pharmacokinetics and safety as they receive daily doses ranging from 150 to 1200 mg. The study also includes an expansion phase for patients with brain metastases once the MTD is established.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced solid tumors harboring the KRAS G12C mutation who have failed or are ineligible for standard therapies.

Not a fit: Patients with other concurrent malignancies or those who have not been genetically tested for the KRAS G12C mutation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new targeted therapy option for patients with KRAS G12C mutated solid tumors.

How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Encinitas, California and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lung CancerNon Small Cell Lung CancerColorectal CancerCancer of PancreasColon CancerSolid TumorCancerKRAS G12C
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.