Study identifier:ACE-LY-001
ClinicalTrials.gov identifier:NCT02328014
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1/2 Proof-of-Concept Study of the Combination of ACP-196 and ACP-319 in Subjects With B-cell Malignancies
Non-Hodgkins Lymphoma
Phase 1/2
No
Acalabrutinib, ACP-319
All
40
Interventional
18 Years - n/a
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jun 2025 by AcertaPharma
AcertaPharma
AstraZeneca
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy acalabrutinib and ACP 319 in B-cell malignancies.
Part 1, Dose Escalation, is comprised of 3 dosing cohorts of 6 subjects each. Acalabrutinib dosing is fixed in all cohorts at 100 mg PO twice daily (BID). In addition to acalabrutinib, subjects in Cohort 1 will receive ACP-319, 25 mg BID; Cohort 2 will receive ACP-319, 50 mg BID: and Cohort 3 will receive ACP-319 100 mg BID. The maximum tolerated dose (MTD) of the study treatment combination will be determined by assessing dose-related toxicities (DLTs) for each cohort at the end of Cycle 1 prior to dose escalation. If there are greater than or equal to 2 DLTs in a cohort, dose escalation will not occur and the MTD will be the highest daily dose for which less than 33% of the subjects in that cohort experienced DLTs in Cycle 1. Part 2, Dose Expansion, includes 12 subjects per histology, dosing at the MTD for the combination of acalabrutinib and ACP-319 established in Part 1. Subjects will continue dosing until disease progression or unacceptable drug-related toxicity.
Location
Location
Seattle, WA, United States, 98109
Location
Austin, TX, United States, 78705
Location
Nashville, TN, United States, 37203
Location
Rochester, NY, United States, 14642
Location
Bethesda, MD, United States, 20892
Location
Orange, CA, United States, 92868
Location
Portland, Oregon, United States, 97239
Arms | Assigned Interventions |
---|---|
Experimental: Dose Escalation and Expansion The acalabrutinib dose will be fixed and the ACP-319 dose will be escalated in each of three cohorts, and each cohort will take both study drugs by mouth, twice per day (BID) at approximately 12 hour intervals. Expansion groups of up to 12 subjects for Germinal center B-cell (GCB) DLBCL and Non-GCB DLBCL to take a fixed dose of acalabrutinib and ACP-319. Each disease group will take both study drugs by mouth, twice per day (BID) at approximately 12 hour intervals. | Drug: Acalabrutinib Oral Other Name: ACP-196 Drug: ACP-319 Oral Other Name: Not Applicable |
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