\[Phase I part\] To investigate the safety, tolerability, and pharmacokinetics of MT-2111 monotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). In addition, the dose to be used in the Phase II part will be confirmed. \[Phase II part\] To evaluate the efficacy of MT-2111 monotherapy in patients with relapsed/refractory DLBCL. In addition, the safety and pharmacokinetics will be investigated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
i.v. infusion
Nagoya Medical Center
Nagoya, Aichi-ken, Japan
Overall response rate (ORR) by independent central review
Time frame: From the date of the first dose of treatment until the date of discontinuation or completion of the study (Up to 48 months)
Duration of response (DOR)
Time frame: The time from the date of first observation of complete response (CR) or partial response (PR) until progressive disease (PD) or death in patients with CR or PR observed (Up to 48 months)
Complete response rate (CRR)
Time frame: From the date of the first dose of treatment until the date of discontinuation or completion of the study (Up to 48 months)
Overall survival (OS)
Time frame: The time from the date of first dose until death regardless of the occurrence of intercurrent event (Up to 48 months)
Progression-free survival (PFS)
Time frame: The time from the date of first dose until PD or death (Up to 48 months)
Relapse-free survival (RFS)
Time frame: The time from the date of first observation of CR until PD or death in patients with CR observed (Up to 48 months)
Adverse events and adverse drug reactions
Time frame: From the start of premedication until 15 weeks after the last dose of the study drug or until the start of new anticancer therapy, whichever comes first.
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG (Eastern Cooperative Oncology Group) Performance Status is scored on a 6-point scale where higher scores indicate a worse outcome.
Time frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
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Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
Aso Iizuka Hospital
Iizuka-shi, Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Gifu Municipal Hospital
Gifu, Gifu, Japan
Gunma Prefectural Cancer Center
Ota-shi, Gunma, Japan
Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Japanese Red Cross Society Himeji Hospital
Himeji-shi, Hyōgo, Japan
...and 13 more locations
Body weight
Time frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
12-lead electrocardiogram (heart rate)
Time frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
12-lead electrocardiogram [RR, PR, QRS, QT (QTcF)]
Time frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
12-lead electrocardiogram (presence or absence of abnormal findings)
Time frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
Serum drug concentration
\[Phase 1 part\] Cycle 1 \[each cycle is 3 weeks (21 days) in duration\]: Day 1, 2, 5, 8 and 15, Cycle 2: Day 1, 2, 8 and 15, Cycle 3: Day 1 and 8, odd number Cycle: Day 1,end of treatment (EOT)\*, and 15 weeks after the last dose \[Phase 2 part\] Cycle 1 and 2: Day 1, 8 and 15, odd number Cycle : Day 1, EOT\*, and 15 weeks after the last dose \*: After the decision to discontinue treatment with study drug and prior to the start of any new anticancer therapy, the scheduled evaluations will be performed preferably 30 days after the last dose of study drug.(Up to 13 months after the first treatment)
Time frame: Cycle 1 (each cycle is 3 weeks): Days 1, 2*, 5*, 8, and 15. Cycle 2: Days 1, 2*, 8, and 15. Cycle 3: Days 1 and 8*. Odd numbered Cycles: Day 1. End of treatment (up to 13 months after first dose), 15 weeks after the last dose. *Phase 1 only.
Anti-drug antibodies (including neutralizing antibodies)
\[Phase 1 part\] Cycle 1 \[each cycle is 3 weeks (21 days) in duration\]: Day 1 and 15, Cycle 2: Day 1, odd number Cycle: Day 1, end of treatment (EOT)\*, and 15 weeks after the last dose \[Phase 2 part\] Cycle 1: Day 1 and 15, Cycle 2: Day 1, odd number Cycle : Day 1, EOT\*, and 15 weeks after the last dose \*: After the decision to discontinue treatment with study drug and prior to the start of any new anticancer therapy, the scheduled evaluations will be performed preferably 30 days after the last dose of study drug.(Up to 13 months after the first treatment)
Time frame: Cycle 1 (each cycle is 3 weeks): Days 1 and 15. Cycle 2: Day 1. Odd numbered cycles: Day 1. End of Treatment (up to 13 months after first dose) and 15 weeks after the last dose.