Clinical Trials

Hematologic Malignancies

Monotherapy Clinical Development

Chronic lymphocytic leukemia (CLL)
Small lymphocytic lymphoma (SLL)
NCT02477696: acalabrutinib vs ibrutinib
R/R CLL
NCT02717611: acalabrutinib
R/R Ibrutinib intolerant CLL
NCT02337829: acalabrutinib
Treatment naïve and R/R Del 17p CLL/SLL
Multiple myeloma (MM)
NCT02211014: acalabrutinib +/- dexamethasone
R/R MM
Chronic lymphocytic leukemia (CLL)
Small lymphocytic lymphoma (SLL) (recruitment complete)
NCT02029443: acalabrutinib first-in-human study
Treatment naïve and R/R CLL
Mantle cell lymphoma (MCL) (recruitment complete)
NCT02213926: acalabrutinib
R/R MCL
Waldenström macroglobulinemia (WM) (recruitment complete)
NCT02180724: acalabrutinib
R/R WM
Diffuse large B cell lymphoma (DLBCL) (recruitment complete)
NCT02112526: acalabrutinib +/- rituximab
R/R de novo ABC DLBCL
Chronic lymphocytic leukemia (CLL) small lymphocytic leukemia
NCT02970318: acalabrutinib vs investigator's choice of idelalisib + rituximab or bendamustine + rituximab in R/R CLL
Tumor or Area Under Investigation
Trial Identifier and Regimen

Combination Clinical Development

Chronic lymphocytic leukemia (CLL)
Small lymphocytic lymphoma (SLL)
NCT02475681: acalabrutinib vs acalabrutinib + obinutuzumab vs obinutuzumab + clb
Treatment naïve CLL
Mantle cell lymphoma (MCL)
NCT02717624: acalabrutinib + bendamustine + rituximab
Treatment naïve and R/R MCL
Follicular lymphoma (FL)
NCT02180711: acalabrutinib +/- rituximab
R/R FL
Other hematologic malignancies
NCT02362035: acalabrutinib + pembrolizumab
Hematologic malignancies
NCT02328014: acalabrutinib + ACP-319
B cell malignancies
Chronic lymphocytic leukemia (CLL)
Small lymphocytic lymphoma (SLL) (recruitment complete)
NCT02157324: acalabrutinib + ACP-319
R/R CLL
NCT02296918: acalabrutinib + obinutuzumab
Treatment naïve and R/R CLL/SLL/PLL
Mantle Cell Lymphoma
NCT02972840: bendamustine and rituximab alone vs in combination with acalabrutinib in subjects with previously untreated mantle cell lymphoma
Tumor or Area Under Investigation
Trial Identifier and Regimen

Solid Tumors

Monotherapy Clinical Development

Glioblastoma multiforme (GBM)
NCT02586857: acalabrutinib monotherapy
Recurrent GBM
Pancreatic cancer (recruitment complete)
NCT02362048: acalabrutinib +/- pembrolizumab
Advanced or metastatic pancreatic cancer
Bladder cancer (recruitment complete)
NCT02351739: acalabrutinib +/- pembrolizumab
Platinum-refractory, metastatic bladder cancer
Head and neck squamous cell carcinoma (HNSCC) (recruitment complete)
NCT02454179: pembrolizumab +/- acalabrutinib
Advanced HNSCC
Non-small cell lung cancer (NSCLC) (recruitment complete)
NCT02448303: pembrolizumab +/- acalabrutinib
Advanced NSCLC
Ovarian cancer (recruitment complete)
NCT02537444: acalabrutinib +/- pembrolizumab
Recurrent ovarian cancer
Tumor or Area Under Investigation
Trial Identifier and Regimen


Acerta Pharma is also conducting multiple healthy volunteer trials and planning additional combination trials in conjunction with AstraZeneca targeted inhibitors.

The information provided here regarding acalabrutinib is for indications that are currently under investigation.

Acalabrutinib is an investigational product and as such is not approved by the US Food and Drug Administration, European Medicines Agency or any other regulatory agency for the uses under investigation.