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

  • STATUS
    Recruiting
  • End date
    Aug 15, 2025
  • participants needed
    44
  • sponsor
    HUYABIO International, LLC.
Send
Updated on 15 October 2022
See if I qualify
KRAS
genetic testing

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.

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.

Details
Condition Lung Cancer, Non Small Cell Lung Cancer, Colorectal Cancer, Cancer of Pancreas, Colon Cancer, Solid Tumor, Cancer
Treatment HBI-2438
Clinical Study IdentifierNCT05485974
SponsorHUYABIO International, LLC.
Last Modified on15 October 2022

Eligibility

 Yes No Not Sure

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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

KRAS
genetic testing

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note