This study is a multi-center, global, open-label, Phase 1b/2 clinical study, and it will be conducted at multiple study sites in several countries, including Japan, Korea, and Singapore, to reveal the safety, tolerability, dose limiting toxicity (DLT), maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), pharmacokinetics (PK), and preliminary efficacy of BCV in patients with relapsed or refractory lymphoma and to assess the efficacy and safety of Brincidofovir (SyB V-1901, BCV) in patients with relapsed or refractory Extranodal Natural Killer/T-cell Lymphoma (ENKL). This study consists of 2 parts and will enroll a total (maximum) of 43 male and female participants who meet the eligibility criteria (Phase 1b part: Up to 18 participants \[3 to 6 participants in each of the 3 cohorts\], Phase 2 part: 25 participants).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Phase 1b part is dose escalation study evaluating three dose levels of BCV, and participants will be assigned to a dose schedule in the order of study entry. In Phase 2 part, participants will receive BCV BIW at the RP2D (determined in the Phase 1b part).
Queen Mary Hospital
Hong Kong, China
Tokyo Metropolitan Komagome Hospital
Bunkyō City, Japan
National Cancer Center Hospital
Chūōku, Japan
Cancer Institute Hospital Of JFCR
Kōtoku, Japan
Kyoto University Hospital
Kyoto, Japan
Okayama University Hospital
Okayama, Japan
Mie University Hospital
Tsu, Japan
National Cancer Centre Singapore
Singapore, Singapore
Phase 1b part (Dose Escalation Part)
Adverse events (AEs) that meet the protocol-defined DLT criteria in Cycle 1 and the number of participants that developed these AEs
Time frame: 28 days
Phase 2 part (Expansion Part)
Best Overall Response as of end of treatment
Time frame: 7 months
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