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NCT05485974 | RECRUITING | Lung Cancer

A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation
Sponsor:

HUYABIO International, LLC.

Brief 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.

Condition or disease

Lung Cancer

Non Small Cell Lung Cancer

Colorectal Cancer

Cancer of Pancreas

Colon Cancer

Solid Tumor

Cancer

Intervention/treatment

HBI-2438

Phase

PHASE1

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 44 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1, Open Label, Dose Escalation of HBI-2438 in Patients With Advanced Malignant Solid Tumors Harboring KRAS G12C Mutation
Actual Study Start Date : 2022-08-01
Estimated Primary Completion Date : 2025-08
Estimated Study Completion Date : 2025-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation

Location Details

NCT05485974

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How to Participate

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Locations

RECRUITING

United States, California

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

Encinitis, California, United States, 92024

RECRUITING

United States, California

The Oncology Institute of Hope and Innovation

Glendale, California, United States, 91204

RECRUITING

United States, California

The Oncology Institute of Hope and Innovation

Long Beach, California, United States, 90805

RECRUITING

United States, California

The Oncology Institute of Hope and Innovation

Pasadena, California, United States, 91105

RECRUITING

United States, California

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

San Marcos, California, United States, 92069

RECRUITING

United States, California

The Oncology Institute of Hope and Innovation

Santa Anna, California, United States, 92705

NOT YET RECRUITING

United States, California

Sarcoma Oncology

Santa Monica, California, United States, 90403

RECRUITING

United States, California

Innovative Clinical Research Institute (ICRI)

Whittier, California, United States, 90603

RECRUITING

United States, California

The Oncology Institute of Hope and Innovation

Whittier, California, United States, 90603

NOT YET RECRUITING

United States, Florida

BRCR Medical Center

Plantation, Florida, United States, 33322

RECRUITING

United States, Road cancer

Michigan Center of Medical Research

Farmington Hills, Road cancer, United States, 48334

RECRUITING

United States, Missouri

Alliance for Multispecialty Research, LLC

Kansas City, Missouri, United States, 64114

RECRUITING

United States, Ohio

Gabrail Cancer Center

Canton, Ohio, United States, 44718

RECRUITING

Puerto Rico,

Pan American Center for Oncology Trials (PanOncology Trials)

Rio Piedras, Puerto Rico, 00935