The main aim of this study are to check for side effects from TAK-853, check how much TAK-853 participants can receive without getting side effects from it, check how well TAK-853 controls symptoms, and to check how much TAK-853 stays in their blood over time. The study will be conducted in two phases including Phase 1 Part and Phase 2 Part. In Phase 1 Part, the participants will stay in the hospital for 3 days at least after their 1st injection for some tests and to check for any side effects from their treatment. In Phase 2 Part, participants will visit their study hospital for multiple times. In both phases, the participants will receive TAK-853 on the first days of each 3-week cycle. The participant will be in the study for about 9 months in Phase 1 Part and for about 24 months in Phase 2 Part. The study doctors will check for side effects from the study treatments.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
TAK-853 intravenous injection
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
Jikei University Kashiwa Hospital
Kashiwa, Chiba, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Shikoku Cancer Center
Matsuyama, Ehime, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Hyogo Cancer Center
Akashi, Hyōgo, Japan
Iwate Medical University Hospital
Shiwa-gun, Iwate, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
...and 10 more locations
Phase 1 Part: Number of Participants with Dose-Limiting Toxicities (DLTs) in Cycle 1
Toxicity will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0. DLT will be defined as any of the events specified in the protocol that are considered by the investigator to be at least possibly related to therapy with study medications.
Time frame: Up to 21 days
Phase 1 Part: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug.
Time frame: 1 year
Phase 1 Part: Number of Participants with Grade 3 or Higher TEAEs
A severity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Grade 1 scales as Mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 scales as Moderate (minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living \[ADL\]); Grade 3 scales as Severe (severe or medically significant but not immediately life threatening hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 scales as Life-threatening consequences, urgent intervention indicated, and Grade 5 scales as Death related to Adverse Event (AE).
Time frame: 1 year
Phase 1 Part: Number of Participants with Serious TEAEs
An SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Time frame: 1 year
Phase 1 Part: Number of Participants with TEAEs Leading to Drug Discontinuation.
Time frame: 1 year
Phase 1 Part: Number of Participants with TEAEs Leading to Infusion Interrupted
Time frame: 1 year
Phase 1 Part: Number of Participants with TEAEs Leading to Dose Delayed
Time frame: 1 year
Phase 1 Part: Number of Participants with TEAEs Leading to Dose Reduction
Time frame: 1 year
Phase 1 Part: Number of Participants with Adverse Event of Clinical Interest (AECIs)
An AE of clinical interest (serious or nonserious) is one of scientific and medical concern specific to the TAK-853, for which ongoing monitoring. Such events may require further investigation to characterize and understand them. AECIs for TAK-853 include: Ocular AEs, Pneumonitis, Peripheral neuropathy, and Infusion related reactions
Time frame: 1 year
Phase 2 Part: Overall Response Rate (ORR) Assessed by Investigator with RECIST 1.1
The ORR is defined as the percentage of participants who achieved a confirmed Partial response (PR) or confirmed Complete response (CR) during the study using RECIST v1.1. Disease response criteria on RECIST 1.1 are following; Complete response (CR): Disappearance of all target lesions. Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time frame: 2 year
Phase 1 Part: Cmax: Maximum Observed Plasma Concentration
Cmax in Phase 1 Part for intact antibody drug conjugate (ADC), Total Antibody (Ab), DM4 and S-methyl DM4 will be reported.
Time frame: 1 year
Phase 1 Part: AUC: Area Under the Plasma Concentration-Time Curve
AUC in Phase 1 Part for intact antibody drug conjugate (ADC), Total Antibody (Ab), DM4 and S-methyl DM4 will be reported.
Time frame: 1 year
Phase 1 Part: T1/2: Terminal Half-Life
T1/2 in Phase 1 Part for intact antibody drug conjugate (ADC), Total Antibody (Ab), DM4 and S-methyl DM4 will be reported.
Time frame: 1 year
Phase 1 Part: CL: Total Clearance
CL in Phase 1 Part for intact antibody drug conjugate (ADC), Total Antibody (Ab), DM4 and S-methyl DM4 will be reported.
Time frame: 1 year
Phase 1 Part: Vss: Volume of Distribution at Steady State
Vss in Phase 1 Part for intact antibody drug conjugate (ADC), Total Antibody (Ab), DM4 and S-methyl DM4 will be reported.
Time frame: 1 year
Phase 1 Part: Tmax: Time of First Occurrence of Cmax
Tmax in Phase 1 Part for intact antibody drug conjugate (ADC), Total Antibody (Ab), DM4 and S-methyl DM4 will be reported.
Time frame: 1 year
Phase 1 Part: Number of Participants with Immunogenicity of TAK-853
Time frame: 1 year
Phase 2 Part: Duration of Response (DOR) Assessed by Investigator with RECIST 1.1
DOR is defined as the time from the date of the first response (CR or PR), whichever occurs first, to the date of PD or death from any cause, whichever occurs first. DOR Responders without documentation of progressive disease will be censored at the date of last response assessment that is SD or better.
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Time frame: 2 year
Phase 2 Part: Observed Plasma Concentration
Observed plasma concentration in Phase 2 Part for intact antibody drug conjugate (ADC), Total Antibody (Ab), DM4 and S-methyl DM4 will be reported.
Time frame: 2 year
Phase 2 Part: Number of Participants with Immunogenicity of TAK-853
Time frame: 2 year