Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors

PHASE1TerminatedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

June 16, 2020

Primary Completion Date

April 5, 2024

Study Completion Date

April 5, 2024

Conditions
Advanced Solid TumorBRAF V600 Mutation
Interventions
DRUG

ABM-1310

"Part A: Starting dose at 25 mg by mouth twice daily.~Part B: Starting dose at a dose below the MTD( Maximum Tolerated Dose) that has been demonstrated to be safe in Part A.~Part C-1 and C-2: Continuous twice daily oral doses of ABM-1310 at the recommended phase 2 dose (RP2D) from Part A until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion is met.~Part C-3 and C-4: Continuous twice daily oral doses of ABM-1310 at the recommended phase 2 dose (RP2D) from Part B until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion is met."

DRUG

Cobimetinib

"Part B: orally administered once daily.~Part C-3 and C-4: Continuous once daily oral dose from Part B, administered the first 21 days of each 28-day treatment cycle until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion is met.~Dose formulation is 60 mg capsules."

Trial Locations (8)

10032

Columbia University Medical Center, New York

33136

University of Miami Hospital Sylvester Comprehensive Cancer Center, Miami

48202

Henry Ford Cancer Institute, Detroit

60611

Robert H. Lurie Comprehensive Cancer Center (Northwestern University), Chicago

77030

MD Anderson Cancer Center, Houston

UTHealth Science Center Houston Department of Neurosurgery, Houston

94158

University of California- San Francisco, San Francisco

94305

Stanford University School of Medicine, Stanford

Sponsors
All Listed Sponsors
lead

ABM Therapeutics Corporation

INDUSTRY