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

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Non Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope, Duarte, California, United States, 91010

Encinitas

California Cancer Associates for Research and Excellence, Inc. (cCare), Encinitas, California, United States, 92024

Fullerton

Providence Medical Foundation, Fullerton, California, United States, 92835

San Marcos

California Cancer Associates for Research and Excellence, Inc. (cCare), San Marcos, California, United States, 92069

Santa Monica

Sarcoma Oncology, Santa Monica, California, United States, 90403

Santa Monica

UCLA Hematology/Oncology, Santa Monica, California, United States, 90404

Orlando

Orlando Health, Inc., Orlando, Florida, United States, 32806

Plantation

BRCR Medical Center, Plantation, Florida, United States, 33322

Canton

Gabrail Cancer Center, Canton, Ohio, United States, 44718

Tyler

Texas Oncology - Tyler, Tyler, Texas, United States, 75702

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

HUYABIO International, LLC.,

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

Study Record Dates

2024-12