Trial Outcomes & Findings for PK,PD,Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Gemcitabine and Oxaliplatin for the Treatment of Patients With Relapsed/Refractory Diffuse Large B Cell Non-Hodgkin's Lymphoma (NCT NCT03488251)

Last Updated: 2022-08-16

Results Overview

A DLT is any treatment-emergent adverse event (TEAE) that occurred after the start of infusion in cycle 1 of Part 1 and the TEAE is at least possibly related to the study drug, as determined by the sponsor after consultation with the investigator(s).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Up to 168 Days

Results posted on

2022-08-16

Participant Flow

This was a 2-part study \[Part 1 (Dose Escalation) and Part 2 (Dose Expansion)\], to investigate safety, tolerability, efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX) in participants with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma.

A total of 8 participants were enrolled in the study. This study was terminated in Part 1 as the potential risks outweighed benefits; hence, Part 1 (Cohorts 2 and 3) and Part 2 were not conducted.

Participant milestones

Participant milestones
Measure	Part 1 Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 micrograms per kilograms (mcg/kg) over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m\^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 2: MT-3724/ GEM/ OX Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Part 1:Dose Escalation (Up to 168 Days) STARTED	8	0	0	0
Part 1:Dose Escalation (Up to 168 Days) COMPLETED	0	0	0	0
Part 1:Dose Escalation (Up to 168 Days) NOT COMPLETED	8	0	0	0
Part 2:Dose Expansion (Up to 168 Days) STARTED	0	0	0	0
Part 2:Dose Expansion (Up to 168 Days) COMPLETED	0	0	0	0
Part 2:Dose Expansion (Up to 168 Days) NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1 Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 micrograms per kilograms (mcg/kg) over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m\^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 2: MT-3724/ GEM/ OX Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Part 1:Dose Escalation (Up to 168 Days) Adverse Event	1	0	0	0
Part 1:Dose Escalation (Up to 168 Days) Physician Decision	1	0	0	0
Part 1:Dose Escalation (Up to 168 Days) Progressive disease	4	0	0	0
Part 1:Dose Escalation (Up to 168 Days) Protocol deviation	1	0	0	0
Part 1:Dose Escalation (Up to 168 Days) Study terminated by sponsor	1	0	0	0

Baseline Characteristics

Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX n=8 Participants In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m\^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 2: MT-3724/ GEM/ OX Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).	Total n=8 Participants Total of all reporting groups
Age, Continuous	70.8 Years STANDARD_DEVIATION 7.42 • n=5 Participants • Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.	—	—	—	70.8 Years STANDARD_DEVIATION 7.42 • n=21 Participants • Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.
Sex: Female, Male Female	1 Participants n=5 Participants • Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.	—	—	—	1 Participants n=21 Participants • Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.
Sex: Female, Male Male	7 Participants n=5 Participants • Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.	—	—	—	7 Participants n=21 Participants • Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants • Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.	—	—	—	1 Participants n=21 Participants • Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.
Race/Ethnicity, Customized White	6 Participants n=5 Participants • Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.	—	—	—	6 Participants n=21 Participants • Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants • Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.	—	—	—	1 Participants n=21 Participants • Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.

PRIMARY outcome

Timeframe: Up to 168 Days

Population: Safety Population consisted of all participants who received at least 1 dose of any study drug (either MT-3724, or gemcitabine or oxaliplatin). Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX n=8 Participants In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m\^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 2: MT-3724/ GEM/ OX Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Part 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)	2 Participants	—	—	—

PRIMARY outcome

Timeframe: Up to 168 Days

Population: Safety Population. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

An AE is as any untoward medical occurrence in a participant or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental intervention(s). A SAE is any AE that is fatal or life-threatening, permanently disabling (incapacitating or interfering with the ability to resume usual life patterns), results in unplanned in-subject hospitalization or prolongation of an existing hospitalization, results in a congenital abnormality or birth defect, or any other situation that require medical or scientific judgement. Number of participants with common \>=0 percent (%) TEAEs and SAEs are presented.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX n=8 Participants In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m\^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 2: MT-3724/ GEM/ OX Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	8 Participants	—	—	—
Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	4 Participants	—	—	—

SECONDARY outcome

Timeframe: Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles)

Population: PK Population. Data was not calculated for Part 1: Cohort 1 due to high proportion of non-quantifiable values (\>30% of values were imputed). Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

Blood samples were planned to be collected at indicated time points for pharmacokinetic (PK) analysis of MT-3724. PK Population consisted of all participants who received at least one dose of MT-3724 and have at least one post-Baseline PK value.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX n=8 Participants In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m\^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 2: MT-3724/ GEM/ OX Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Part 1 and 2: Maximum Concentration (Cmax) Following Administration of MT-3724	NA Micrograms per milliliter Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30% of values were imputed)	—	—	—

SECONDARY outcome

Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX n=8 Participants In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m\^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 2: MT-3724/ GEM/ OX Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Part 1 and 2: Area Under the Plasma Concentration Time Curve (AUC) Following Administration of MT-3724	NA Hours*micrograms per milliliter Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30% of values were imputed)	—	—	—

SECONDARY outcome

Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX n=8 Participants In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m\^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 2: MT-3724/ GEM/ OX Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Part 1 and 2: Time to Maximum Plasma Concentration (Tmax) Following Administration of MT-3724	NA Hours Median and Full Range could not be calculated due to high proportion of non-quantifiable values (\>30% of values were imputed)	—	—	—

SECONDARY outcome

Timeframe: Up to 168 Days

Population: Safety Population. Data was not calculated for Part 1: Cohort 1 as 100% of data was below limit of quantification at all time points. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

Blood samples were planned to be collected at indicated time points for analysis of immunophenotyping parameters which included cluster of differentiation (CD)3 (Percentage \[%\] and absolute), CD4 (% and absolute), CD8 (% and absolute), CD4:CD8 ratio, CD19 (% and absolute), Natural Killer (NK) cells (% and absolute), naïve B cells (% and absolute), non-switched memory B cells (% and absolute), class-switched memory B cells, Immunoglobulin (Ig)M only memory B cells (% and absolute), and total memory B cells (% and absolute).

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX n=8 Participants In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m\^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 2: MT-3724/ GEM/ OX Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Part 1 and 2: Number of Participants With Immunophenotyping Data Outside the Reference Range	NA Participants NA indicates that data could not be calculated as 100% of data was below limit of quantification at all time points	—	—	—

SECONDARY outcome

Timeframe: Up to 168 Days

Population: Immunogenicity population: All participants who received at least one dose of MT-3724 and have at least one post-Baseline immunogenicity assessment. Data was not calculated for Part 1: Cohort 1 as 100% of data was below limit of quantification at all time points. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

Blood samples were planned to be collected at indicated time points for analysis of anti-drug antibody titer.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX n=8 Participants In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m\^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 2: MT-3724/ GEM/ OX Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Part 1 and 2: Number of Participants With Anti-drug Antibody Titer	NA Participants NA indicates that data could not be calculated as 100% of data was below limit of quantification at all time points	—	—	—

SECONDARY outcome

Timeframe: Up to 168 Days

Population: Immunogenicity population. Data was not calculated for Part 1: Cohort 1 as 100% of data was below limit of quantification at all time points. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

Blood samples were planned to be collected at indicated time points for analysis of positive neutralizing antibodies.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX n=8 Participants In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m\^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 2: MT-3724/ GEM/ OX Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Part 1 and 2: Number of Participants With Positive Neutralizing Antibodies	NA Participants NA indicates that data could not be calculated as 100% of data was below limit of quantification at all time points	—	—	—

SECONDARY outcome

Timeframe: Up to 168 Days

Population: Efficacy Population: All participants who received at least 1 dose of any study drug and have the Baseline tumor assessment as well as at least one post-Baseline tumor assessment. Only those participants with data available at the specified time points were analyzed. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

Objective response rate is defined as the participants with a reduction in tumor size (Partial Response \[PR\] or Complete Response \[CR\]) using the Lugano Classification for Lymphoma, adjusted according to Lymphoma response to immunomodulatory therapy criteria (LYRIC).

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX n=7 Participants In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m\^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 2: MT-3724/ GEM/ OX Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Part 1 and 2: Objective Response Rate	3 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to 168 Days

Population: Efficacy Population. Only those participants with data available at the specified time points were analyzed. Data could not be calculated for Part 1: Cohort 1 as no participants had a confirmed CR or PR. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial.

Disease Control rate is defined as participants with objective response of CR, PR or stable disease (SD) defined as SD for 3 months or longer from the Baseline scan.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX n=7 Participants In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m\^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 2: MT-3724/ GEM/ OX Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Part 1 and 2: Disease Control Rate	NA Participants NA indicates that data could not be calculated as no participants had a confirmed CR or PR	—	—	—

SECONDARY outcome

Timeframe: Up to 168 Days

Duration of Response is defined as the time from first documented stable disease to the actual date of disease progression or death, for participants who met the criteria of having stable disease for at least 3 months from Baseline. Data was not collected due to early termination of the trial.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX n=7 Participants In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m\^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 2: MT-3724/ GEM/ OX Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Part 1 and 2: Duration of Response	NA Months NA indicates that data could not be calculated as no participants had a confirmed CR or PR	—	—	—

SECONDARY outcome

Timeframe: Up to 168 Days

Progression-Free Survival is defined as the time from the start of treatment with MT-3724 on Cycle 1 Day 1 to the date of disease progression or death from any cause. Data was not collected due to early termination of the trial.

Outcome measures

Outcome measures
Measure	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX n=7 Participants In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m\^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 2: MT-3724/ GEM/ OX Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Part 1 and 2: Progression-free Survival	NA Months NA indicates that data could not be calculated as no participants had a confirmed CR or PR	—	—	—

Adverse Events

Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2: MT-3724/ GEM/ OX

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX n=8 participants at risk In original protocol and amendment 2, participants were administered intravenous (IV) MT-3724 10 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also administered Gemcitabine 1000 milligrams per meter square (mg/m\^2) as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were administered MT-3724 10 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 10 mcg/kg was administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 25 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 25 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 25 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX In original protocol and amendment 2, participants were planned to be administered IV MT-3724 50 mcg/kg over 1 hour on Days 1, 3, 5, 8, 10 and 12 in Cycles 1 and 2 (each 28-day cycle) and on Days 1, 8, 15, and 22 in Cycles 3 and 4 (each 28-day cycle). Participants were also planned to be administered Gemcitabine 1000 mg/m\^2 as 30-minute IV infusion and Oxaliplatin 100 mg/m\^2 as 2-hour IV infusion on Days 2 and 16 in Cycles 1, 2, 3 and 4 (each 28-day cycle). Per amendment 2, participants were planned to be administered MT-3724 50 mcg/kg on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 in Cycle 1 (42-day cycle). In Cycles 2, 3 and 4, MT-3724 50 mcg/kg was planned to be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin were planned to be administered on Days 16 and 30 of Cycle 1 and on Days 2 and 16 in Cycles 2, 3 and 4 (42-day cycle for Cycle 1 and 28-day cycle for Cycle 2, Cycle 3 and Cycle 4).	Part 2: MT-3724/ GEM/ OX Participants were planned to be administered Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX).
Vascular disorders Capillary leak syndrome	25.0% 2/8 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 168 days in Part 1. Safety Population. Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.	— 0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 168 days in Part 1. Safety Population. Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.	— 0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 168 days in Part 1. Safety Population. Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.	— 0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 168 days in Part 1. Safety Population. Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.
Cardiac disorders Atrial flutter	12.5% 1/8 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 168 days in Part 1. Safety Population. Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.	— 0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 168 days in Part 1. Safety Population. Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.	— 0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 168 days in Part 1. Safety Population. Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.	— 0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 168 days in Part 1. Safety Population. Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.
Nervous system disorders Chemotherapy induced neurotoxicity	12.5% 1/8 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 168 days in Part 1. Safety Population. Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.	— 0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 168 days in Part 1. Safety Population. Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.	— 0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 168 days in Part 1. Safety Population. Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.	— 0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 168 days in Part 1. Safety Population. Only data for Part 1: Cohort 1 is presented as study was terminated in Part 1 due to premature closure of the trial driven by an unfavorable risk benefit assessment in the concurrent monotherapy study; hence Part 1 (Cohort 2 and 3) and Part 2 were not initiated.

Other adverse events

Additional Information

Study Director

Molecular Templates, Inc.

Phone: 512 930-0304

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER