This clinical trial is evaluating a drug called AC676 in participants with Relapsed/Refractory B-cell Malignancies. The main goals of the study are to: * Identify the recommended dose of AC676 that can be given safely to participants * Evaluate the safety profile of AC676 * Evaluate the pharmacokinetics of AC676 * Evaluate the effectiveness of AC676
AC676-001 is a Phase I, first-in-human, open-label, multi-center dose-escalation study of AC676 given as a single agent. AC676 is an investigational medicinal product that is an orally bioavailable BTK degrader for the treatment of B-cell malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
AC676 will be given orally (PO) on a 28-day cycle.
Colorado Blood Cancer Institute
Denver, Colorado, United States
RECRUITINGFlorida Cancer Specialists
Sarasota, Florida, United States
RECRUITINGIncidence of dose limiting toxicities (DLTs) from AC676 monotherapy
Time frame: From cycle 1 day 1 to Cycle 1 day 28. Cycles are 28 days.
Incidence of treatment-emergent adverse events (TEAEs) and clinically significant Grade 3 or higher laboratory abnormalities using CTCAE v5.0 criteria.
Time frame: Approximately 18 months
Maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D)
Time frame: Approximately 18 months
Pharmacokinetic Analysis: area under the plasma concentration-time curve over the dosing interval (AUC(0-inf))
Time frame: Up to approximately 20 weeks
Pharmacokinetic Analysis: area under the plasma concentration-time curve from over the dosing interval (AUC(0-tau))
Time frame: Up to approximately 20 weeks
Pharmacokinetic Analysis: maximum plasma concentration (Cmax)
Time frame: Up to approximately 20 weeks
Pharmacokinetic Analysis: time to maximum plasma concentration (tmax)
Time frame: Up to approximately 20 weeks
Pharmacokinetic Analysis: terminal elimination half-life (t1/2)
Time frame: Up to approximately 20 weeks
Objective Response Rate (ORR) in patients receiving AC676
Time frame: Approximately 18 months
Duration of Response (DOR) in patients receiving AC676
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University of North Carolina
Chapel Hill, North Carolina, United States
RECRUITINGUniversity Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITINGThe Ohio State University - The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
RECRUITINGOregon Health & Science University
Portland, Oregon, United States
RECRUITINGTennessee Oncology
Nashville, Tennessee, United States
WITHDRAWNUniversity of Texas Southwestern Medical Center
Dallas, Texas, United States
RECRUITINGSwedish Cancer Institute
Seattle, Washington, United States
RECRUITINGTime frame: Approximately 18 months
Time to Response (TTR) in patients receiving AC676
Time frame: Approximately 18 months
Disease Control Rate (DCR) in patients receiving AC676
Time frame: Approximately 18 months
Progression Free Survival rate (PFS) in patients receiving AC676
Time frame: Approximately 18 months