ACTIVE_NOT_RECRUITING

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

Conditions

Non Small Cell Lung Cancer Colorectal Cancer Pancreatic Cancer Solid Tumor Cancer Cancer of Pancreas Cancer of Colon KRAS EGFR SHP2 FIH

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1, Open-Label, Dose Escalation of HBI-2376 in Patients With Advanced Malignant Solid Tumors Harboring KRAS or EGFR Mutations

Quick Facts

Study Start:2021-12-13

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05163028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Ravi Salgia, MD

PRINCIPAL_INVESTIGATOR

City of Hope Comprehensive Cancer Center

Study Locations (Sites)

City of Hope

Duarte, California, 91010

United States

California Cancer Associates for Research and Excellence, Inc. (cCare)

Encinitas, California, 92024

United States

Providence Medical Foundation

Fullerton, California, 92835

United States

California Cancer Associates for Research and Excellence, Inc. (cCare)

San Marcos, California, 92069

United States

Sarcoma Oncology

Santa Monica, California, 90403

United States

UCLA Hematology/Oncology

Santa Monica, California, 90404

United States

Orlando Health, Inc.

Orlando, Florida, 32806

United States

BRCR Medical Center

Plantation, Florida, 33322

United States

Gabrail Cancer Center

Canton, Ohio, 44718

United States

Texas Oncology - Tyler

Tyler, Texas, 75702

United States

Virginia Cancer Specialists

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: HUYABIO International, LLC.

Ravi Salgia, MD, PRINCIPAL_INVESTIGATOR, City of Hope Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-13

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-12-13

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

KRAS
EGFR
SHP2
FIH

Additional Relevant MeSH Terms

Non Small Cell Lung Cancer
Colorectal Cancer
Pancreatic Cancer
Solid Tumor
Cancer
Cancer of Pancreas
Cancer of Colon