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The purpose of this study is to evaluate the safety and tolerability of MT-3724 in combination with gemcitabine and oxaliplatin (GEMOX) in participants with relapsed or refractory B-Cell NHL.
This is a multi-center, open-label two-part study evaluating the safety and tolerability of MT-3724 in combination with GEMOX in relapsed or refractory B-cell Lymphoma patients.
Part 1: (MT-3724 Dose Escalation) Define the maximum tolerated dose (MTD) of MT-3724 in combination with standard treatment of GEMOX
Part 2: (MTD Expansion Cohort) Confirm the safety and tolerability of the MTD of MT-3724 from Part 1 in the MTD Expansion Cohort, where MT-3724 will be given at the MTD in combination with GEMOX. In addition, the PK, PD, immunogenicity and tumor response at the MTD of MT-3724 in combination with GEMOX will be more thoroughly evaluated in Part 2.
In original protocol and amendment 2, participants will be administered intravenous (IV) MT-3724 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 will also be 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 will be administered MT-3724 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 will be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin will 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).
Continued Treatment with MT-3724 in combination with GEMOX will continue for four cycles of until death, disease progression, unacceptable toxicity, withdrawal of consent or another reason for withdrawal.
After four cycles, the participants who experience clinical benefit can continue MT-3724 treatment with additional cycles of 28 days each (either alone or in combination with GEMOX) if supported by the investigator's assessment of the benefit-risk ratio, after consultation with sponsor and Medical Monitor
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | Experimental | In original protocol and amendment 2, participants will be 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 will also be 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 will be 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 will be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin will 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 2: MT-3724 25 mcg/kg/ GEM/ OX | Experimental | In original protocol and amendment 2, participants will be planned to administer 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 will also be planned to administer 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 will be planned to administer 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 will be planned to administer weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin will be planned to administer 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-3724 | Drug | MT-3724 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs) | 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). | Up to 168 Days |
| Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. | Up to 168 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and 2: Maximum Concentration (Cmax) Following Administration of MT-3724 | 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. | 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) |
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Inclusion Criteria:
Be adequately informed about the study and fully consent to participation as demonstrated by signing the written informed consent form before any screening procedure.
Be aged ≥18 years on the date of signing the informed consent form.
Have relapsed or refractory B-cell NHL that, in the investigator's opinion, could benefit from MT-3724+GEMOX therapy. At least one histologically documented relapse of NHL, by:
All subtypes of B-cell NHL may be considered for Part 1 (MT-3724 dose escalation). Only histologically documented DLBCL (including mixed histology) may be considered for Part 2 (expansion cohort).
Have received all approved therapies for NHL that are applicable for the patient in the opinion of the treating physician.
Have measurable disease by Lugano Classification for NHL
Have ECOG performance score of ≤2.
Have adequate bone marrow function, as determined by:
Have adequate kidney function, assessed by thecreatinine clearance (CLcr) to be ≥ 50 mL/min either measured or estimated using the Cockcroft-Gault formula. .
a. At the investigator's discretion,calculated estimated CLcr of < 50mL/min may be verified eGFR based on the 24-hour urine collection. Subjects with GFR ≥50 mL/min will be eligible irrespective of the estimated CLcr result.
Have adequate hepatic function, as determined by:
Have adequate coagulation, as determined by:
Have adequate serum albumin, as determined by:
a. Albumin ≥ 3.0 g/dL
Women of reproductive potential must have a negative pregnancy test during the screening period within 72 hours before the start of treatment. Women not of reproductive potential are female subjects who are postmenopausal or permanently sterilized (e.g., tubal occlusion, hysterectomy,bilateral salpingectomy).
Subjects of reproductive potential and their partners must agree to either to abstain continuously from heterosexual intercourse or to use a reliable birth control method between signing the informed consent until 6 months following the last dose of MT-3724 or GEMOX . The investigator or a designated associate should advise the subject how to achieve adequate contraception. The following birth control methods may be considered as adequate
Exclusion criteria:
History or current evidence of neoplastic disease that is histologically distinct from NHL except cervical carcinoma in situ, superficial noninvasive bladder tumors, curatively treated Stage I-II non-melanoma skin cancer, or any other previous cancer curatively treated >2 years before the start of treatment.
Current evidence of new or growing brain or spinal metastases during screening.
History of allogeneic hematopoietic stem cell transplant within 180 days before the start of treatment.
Current evidence of acute or chronic Graft versus Host Disease.
Current evidence of CTCAE Grade >1 toxicity (except for hair loss, and those toxicities
Current evidence of incomplete recovery from surgery before the start of treatment, or planned surgery at any time during the study until the EoT Visit, except minor elective interventions deemed acceptable by the investigator.
History or current evidence of significant (CTCAE Grade ≥2) infection or wound within 4 weeks before the start of treatment.
Patients with uncontrolled or severe cardiovascular disease, including myocardial infarct or unstable angina within 6 months prior to start of study treatment, New York Heart Association (NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, or cardiac amyloidosis may not be enrolled.
Patients with a known history of drug abuse or any chronic neurologic, psychiatric, endocrine, metabolic, immunologic, hepatic or renal disease (including a history of hemolytic uremic syndrome) that in the opinion of the Investigator would adversely affect study participation.
Patients with known active Hepatitis C, HIV or a present history of Hepatitis B
Women who are pregnant or breastfeeding
History or current evidence of hypersensitivity to any study drugs, or current evidence of hypersensitivity requiring systemic steroid doses ≥20 mg/day Prednisone equivalent
Received any amount of anti-CD20 MAb therapy within the following periods before the start of treatment
Received therapy for NHL (except anti-CD20 Mab listed above) within 4 weeks before the start of treatment
Any investigational drug treatment from 4 weeks or 5 half-lives of the agent before the start of treatment, whichever is longer, until the EoT Visit
Received radiotherapy to tumor lesions that would be chosen as target lesions (measurable disease) within 4 weeks before the start of treatment, unless the lesion exhibited objective progression between the radiotherapy and the screening according to the Lugano Classification for NHL.
a. Palliative radiotherapy to non-target lesions is allowed at the investigator's discretion after consultation with the Medical Monitor and sponsor.
Received any vaccines within 28 days of the start of treatment, or likely to require vaccines at any time from the start of treatment until 28 days after the last dose of MT-3724. Injectable flu vaccine (inactivated or recombinant) is permitted at the investigator's discretion
Received systemic immune modulators within 2 weeks before the start of treatment including but not limited to systemic corticosteroids >20 mg/day of prednisone equivalent, cyclosporine and tacrolimus. Corticosteroids for pre-medication and NSAIDs are permitted.
Received any investigational drug treatment within 4 weeks or within 5 half-lives of the therapeutic agent before the start of treatment, whichever is longer, until EoT Visit
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Irvine Health / Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States | ||
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1:Dose Escalation (Up to 168 Days) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 14, 2019 | May 26, 2022 |
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| Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | Experimental | In original protocol and amendment 2, participants will be planned to administer 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 will also be planned to administer 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 will be planned to administer 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 will be planned to administer weekly on Days 1, 8, 15, and 22 of each 28-day cycle. Gemcitabine and oxaliplatin will be planned to administer 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 | Experimental | Participants will be planned to administer Maximum tolerated dose (MTD) of MT-3724 in combination with Gemcitabine and Oxaliplatin (GEMOX). |
|
| Gemcitabine | Drug | Gemcitabine will be administered. |
|
| Oxaliplatin | Drug | Oxaliplatin will be administered. |
|
| Part 1 and 2: Area Under the Plasma Concentration Time Curve (AUC) Following Administration of MT-3724 | Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724. | 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) |
| Part 1 and 2: Time to Maximum Plasma Concentration (Tmax) Following Administration of MT-3724 | Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724. | 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) |
| Part 1 and 2: Number of Participants With Immunophenotyping Data Outside the Reference Range | 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). | Up to 168 Days |
| Part 1 and 2: Number of Participants With Anti-drug Antibody Titer | Blood samples were planned to be collected at indicated time points for analysis of anti-drug antibody titer. | Up to 168 Days |
| Part 1 and 2: Number of Participants With Positive Neutralizing Antibodies | Blood samples were planned to be collected at indicated time points for analysis of positive neutralizing antibodies. | Up to 168 Days |
| Part 1 and 2: Objective Response Rate | 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). | Up to 168 Days |
| Part 1 and 2: Disease Control Rate | 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. | Up to 168 Days |
| Part 1 and 2: Duration of Response | 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. | Up to 168 Days |
| Part 1 and 2: Progression-free Survival | 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. | Up to 168 Days |
| Sarcoma Oncology |
| Santa Monica |
| California |
| 90403 |
| United States |
| Innovative Clinical Research Institute | Whittier | California | 90603 | United States |
| Rush University | Chicago | Illinois | 60612 | United States |
| Indiana Blood and Marrow Transplantation | Indianapolis | Indiana | 46237 | United States |
| University of Maryland Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | United States |
| Duke Cancer Center | Durham | North Carolina | 27710 | United States |
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States |
| UT Southwestern Medical Center Clinical Research | Dallas | Texas | 75390 | United States |
| FG001 | 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). |
| FG002 | 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). |
| FG003 | 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). |
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| NOT COMPLETED |
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| Part 2:Dose Expansion (Up to 168 Days) |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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). |
| BG001 | 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). |
| BG002 | 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). |
| BG003 | 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). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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. | Mean | Standard Deviation | Years |
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| Sex: Female, Male | 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. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Part 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs) | 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). | 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. | Posted | Count of Participants | Participants | Up to 168 Days |
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| Primary | Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. | Safety Population. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Posted | Count of Participants | Participants | Up to 168 Days |
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| Secondary | Part 1 and 2: Maximum Concentration (Cmax) Following Administration of MT-3724 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | 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) |
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| Secondary | Part 1 and 2: Area Under the Plasma Concentration Time Curve (AUC) Following Administration of MT-3724 | Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*micrograms per milliliter | 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) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Part 1 and 2: Time to Maximum Plasma Concentration (Tmax) Following Administration of MT-3724 | Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724. | 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. | Posted | Median | Full Range | Hours | 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) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Part 1 and 2: Number of Participants With Immunophenotyping Data Outside the Reference Range | 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). | 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. | Posted | Count of Participants | Participants | Up to 168 Days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 1 and 2: Number of Participants With Anti-drug Antibody Titer | Blood samples were planned to be collected at indicated time points for analysis of anti-drug antibody titer. | 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. | Posted | Count of Participants | Participants | Up to 168 Days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 1 and 2: Number of Participants With Positive Neutralizing Antibodies | Blood samples were planned to be collected at indicated time points for analysis of positive neutralizing antibodies. | 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. | Posted | Count of Participants | Participants | Up to 168 Days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 1 and 2: Objective Response Rate | 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). | 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. | Posted | Count of Participants | Participants | Up to 168 Days |
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| Secondary | Part 1 and 2: Disease Control Rate | 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. | 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. | Posted | Count of Participants | Participants | Up to 168 Days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 1 and 2: Duration of Response | 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. | 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. | Posted | Median | Inter-Quartile Range | Months | Up to 168 Days |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Part 1 and 2: Progression-free Survival | 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. | 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. | Posted | Median | Inter-Quartile Range | Months | Up to 168 Days |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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). | 0 | 8 | 4 | 8 | 8 | 8 |
| EG001 | 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). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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). | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Capillary leak syndrome | Vascular disorders | MedDra 23.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDra 23.0 | Systematic Assessment |
| |
| Chemotherapy induced neurotoxicity | Nervous system disorders | MedDra 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDra 23.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDra 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDra 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 23.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDra 23.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDra 23.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDra 23.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDra 23.0 | Systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDra 23.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDra 23.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDra 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 23.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDra 23.0 | Systematic Assessment |
| |
| Restless leg syndrome | Nervous system disorders | MedDra 23.0 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDra 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDra 23.0 | Systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDra 23.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDra 23.0 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDra 23.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDra 23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDra 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra 23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDra 23.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDra 23.0 | Systematic Assessment |
| |
| Early satiety | General disorders | MedDra 23.0 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDra 23.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDra 23.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDra 23.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDra 23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDra 23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDra 23.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDra 23.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDra 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDra 23.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDra 23.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDra 23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDra 23.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDra 23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDra 23.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDra 23.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDra 23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDra 23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDra 23.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDra 23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDra 23.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDra 23.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDra 23.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDra 23.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDra 23.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDra 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDra 23.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDra 23.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDra 23.0 | Systematic Assessment |
| |
| Libido increased | Psychiatric disorders | MedDra 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDra 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 23.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDra 23.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDra 23.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDra 23.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDra 23.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDra 23.0 | Systematic Assessment |
| |
| Capillary leak syndrome | Vascular disorders | MedDra 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDra 23.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDra 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 23.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDra 23.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDra 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | MedDra 23.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDra 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDra 23.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDra 23.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDra 23.0 | Systematic Assessment |
| |
| Rash maculo-popular | Skin and subcutaneous tissue disorders | MedDra 23.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDra 23.0 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 23.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDra 23.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDra 23.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDra 23.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra 23.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDra 23.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDra 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDra 23.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDra 23.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDra 23.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDra 23.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDra 23.0 | Systematic Assessment |
| |
| Spontaneous penile erection | Reproductive system and breast disorders | MedDra 23.0 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDra 23.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Molecular Templates, Inc. | 512 930-0304 | trials@mtem.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2021 | May 26, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| White |
|
| Unknown |
|
| OG001 | 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). |
| OG002 | 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). |
| OG003 | 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). |
|
|
| OG001 | 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). |
| OG002 | 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). |
| OG003 | 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). |
|
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| OG001 | 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). |
| OG002 | 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). |
| OG003 | 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). |
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| OG001 | 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). |
| OG002 | 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). |
| OG003 | 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). |
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| OG001 | 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). |
| OG002 | 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). |
| OG003 | 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). |
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| 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). |
| OG002 | 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). |
| OG003 | 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). |
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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). |
| OG002 | 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). |
| OG003 | 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). |
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| OG001 | 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). |
| OG002 | 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). |
| OG003 | 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). |
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| 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). |
| OG002 | 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). |
| OG003 | 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). |
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| OG001 | 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). |
| OG002 | 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). |
| OG003 | 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). |
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| OG001 |
| 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). |
| OG002 | 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). |
| OG003 | 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). |
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