Talabostat and Pembrolizumab for the Treatment of Advanced Solid Cancers
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|ClinicalTrials.gov Identifier: NCT04171219|
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : March 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Solid Neoplasm Recurrent Malignant Solid Neoplasm||Biological: Pembrolizumab Drug: Talabostat Drug: Talabostat Mesylate||Phase 2|
I. To evaluate response rate per Response Evaluation Criteria in Solid Tumors (RECIST) and immune (i)RECIST in patients treated in cohort A and in patients treated in cohort B.
II. To evaluate dose-limiting toxicities (DLT) in the first 6 patients enrolled to the study.
I. To evaluate progression-free survival (PFS). II. To evaluate duration of response (DOR). III. To evaluate overall survival (OS). IV. To evaluate overall safety and tolerability.
I. To evaluate the quantitative and qualitative effects of talabostat (BXCL701) in combination with pembrolizumab on relevant immune effector cytokines in blood.
II. To evaluate the quantitative and qualitative effects of BXCL701 in combination with pembrolizumab on various immunological effector cells, including neutrophils, myeloid derived suppressor cells (MDSCs), dendritic cells, cancer associated fibroblast (CAF), T-cells and macrophage density in pre-dose tumor biopsies and when feasible in post-dose tumor tissues.
III. To explore the predictive value of baseline programmed death ligand 1 (PD-L1) tumor expression and tumor mutation burden (TMB) with clinical outcomes.
IV. To evaluate changes in serially collected blood circulating tumor deoxyribonucleic acid (DNA) (ctDNA) to assess for tumor response and clonal evolution.
V. To evaluate pre- and post-treatment PD-L1 positron emission tomography (PET)/computed tomography (CT) as a predictive tool for therapeutic efficacy.
Patients receive talabostat orally (PO) on days 1-14 and pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Basket Study of BXCL701, a Small Molecule Inhibitor of Dipeptidyl Peptidases (DPP), Administered in Combination With Pembrolizumab in Patients With Advanced Solid Cancers|
|Actual Study Start Date :||March 19, 2020|
|Estimated Primary Completion Date :||February 28, 2023|
|Estimated Study Completion Date :||February 28, 2023|
Experimental: Treatment (talabostat, pembrolizumab)
Patients receive talabostat PO on days 1-14 and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Talabostat Mesylate
Other Name: Val-boro-Pro
- Response rate [ Time Frame: Up to 2.5 years ]Evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) and immune (i)RECIST.
- Dose limiting toxicity [ Time Frame: Cycle 1; each cycle is 28 days ]Toxicities will be assessed by the investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04171219
|Contact: Filip Jankufirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Filip Janku 713-563-1930|
|Principal Investigator: Filip Janku|
|Principal Investigator:||Filip Janku||M.D. Anderson Cancer Center|