A Study of HC-7366 to Establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

PHASE1TerminatedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

February 23, 2022

Primary Completion Date

February 9, 2024

Study Completion Date

March 1, 2024

Conditions
Squamous Cell Carcinoma of Head and NeckColo-rectal CancerNon Small Cell Lung CancerTransitional Cell Carcinoma of the BladderOther Solid TumorsClear Cell Renal Cell Carcinoma
Interventions
DRUG

HC-7366

HC-7366 drug product is an immediate release capsule formulation of HC-7366 potassium salt monohydrate (HC-7366-K) in a hard gelatin capsule for oral administration. Each capsule contains HC-7366-K monohydrate (the active ingredient), lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. Capsules are supplied in 3 strengths: 10, 25, and 100 mg HC-7366 free acid equivalent.

Trial Locations (7)

37203

Sarah Cannon Research Institute /Tennessee Oncology, Nashville

37232

Vanderbilt-Ingram Cancer Center, Nashville

63110

Washington University School of Medicine, St Louis

77030

The University of Texas M.D. Anderson Cancer Center, Houston

80045

University of Colorado Anschutz Medical Campus, Aurora

92093

UC San Diego Moores Cancer Center, La Jolla

98104

Swedish Cancer Institute, Seattle

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Covance

INDUSTRY

lead

HiberCell, Inc.

INDUSTRY