Colon Cancer Clinical Trial

A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations

Summary

A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS or EGFR mutations to determine the maximum tolerated dose and recommended Phase II dose of HBI-2376 and characterize its pharmacokinetic profile.

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Full Description

A Phase 1, Open-Label, Dose Escalation of HBI-2376 in Patients with Advanced Malignant Solid Tumors Harboring KRAS or EGFR Mutations. The primary and secondary objectives are:

To determine the MTD and recommended Phase 2 dose (RP2D), of HBI-2376 as an oral monotherapy for advanced solid tumors harboring KRAS or EGFR mutations
To characterize the PK of HBI-2376 in subjects with advanced malignant solid tumors harboring KRAS or EGFR mutations

HBI-2376 is a SHP2 Inhibitor and will be dosed once daily throughout the escalation and expansion phase. Up to 42 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 6 to 40mg. Once the MTD of RP2D is established, additional 6 subjects will be enrolled into the expansion phase at that dose level.

View Eligibility Criteria

Eligibility 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 or EGFR mutations diagnosed by histology or cytology
Relapsed or refractory to, or intolerant of, or refuse approved or standard of care established therapy known to provide clinical benefit for disease
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
Must be able to swallow oral medications and must not have gastrointestinal abnormalities that significantly affect drug absorption

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
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 SHP2 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

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

42

Study ID:

NCT05163028

Recruitment Status:

Recruiting

Sponsor:

HUYABIO International, LLC.

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There are 12 Locations for this study

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City of Hope
Duarte California, 91010, United States More Info
Susan Hmwe
Contact
626-218-4404
[email protected]
Ravi Salgia, MD
Sub-Investigator
California Cancer Associates for Research and Excellence, Inc. (cCare)
Encinitas California, 92024, United States More Info
Christina Spencer
Contact
760-452-3909
[email protected]
Alberto Bessudo, MD
Principal Investigator
Providence Medical Foundation
Fullerton California, 92835, United States More Info
David J Park, MD
Principal Investigator
California Cancer Associates for Research and Excellence, Inc. (cCare)
San Marcos California, 92069, United States More Info
Christina Spencer
Contact
760-452-3909
[email protected]
Alberto Bessudo, MD
Principal Investigator
Sarcoma Oncology
Santa Monica California, 90403, United States More Info
Victoria S Chua-Alcala, MD, CLS
Contact
310-552-9999
[email protected]
Sant Chawla, MD
Principal Investigator
UCLA Hematology/Oncology
Santa Monica California, 90404, United States More Info
Joanna Gutierrez
Contact
310-633-8400
mailto:[email protected]
Jonathan Goldman, MD
Principal Investigator
Orlando Health, Inc.
Orlando Florida, 32806, United States More Info
Kiera Grofsik
Contact
321-841-6626
[email protected]
Sajeve Thomas, MD
Principal Investigator
BRCR Medical Center
Plantation Florida, 33322, United States More Info
Ines Padron
Contact
561-447-0614
[email protected]
Harshad Amin, MD
Principal Investigator
Gabrail Cancer Center
Canton Ohio, 44718, United States More Info
Nashat Gabrail, MD
Principal Investigator
Texas Oncology - Tyler
Tyler Texas, 75702, United States More Info
Penny Watkins, RN
Contact
903-579-9800
[email protected]
Donald A Richards, MD, PhD
Principal Investigator
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States More Info
Cynthia DeLeon
Contact
210-580-9521
[email protected]
Alexander Spira, MD, PhD
Principal Investigator
Pan American Center for Oncology Trials (PanOncology Trials)
Rio Piedras , 00935, Puerto Rico More Info
Marcia R Cruz-Correa, MD,PhD,AGAF,FASGE
Contact
787-407-3333
[email protected]
Marcia R Cruz-Correa, MD,PhD,AGAF,FASGE
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

42

Study ID:

NCT05163028

Recruitment Status:

Recruiting

Sponsor:


HUYABIO International, LLC.

How clear is this clinincal trial information?

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