UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061352 |
|---|---|
| Receipt number | R000070043 |
| Scientific Title | Elucidation of Factors Contributing to Interindividual Variability in Pharmacokinetics and Clinical Efficacy of MMAE Based Antibody Drug Conjugates |
| Date of disclosure of the study information | 2026/04/22 |
| Last modified on | 2026/04/22 14:59:36 |
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Basic information
Public title
Elucidation of Factors Contributing to Interindividual Variability in Pharmacokinetics and Clinical Efficacy of MMAE Based Antibody Drug Conjugates
Acronym
Elucidation of Factors Contributing to Interindividual Variability in Pharmacokinetics and Clinical Efficacy of MMAE Based Antibody Drug Conjugates
Scientific Title
Elucidation of Factors Contributing to Interindividual Variability in Pharmacokinetics and Clinical Efficacy of MMAE Based Antibody Drug Conjugates
Scientific Title:Acronym
Elucidation of Factors Contributing to Interindividual Variability in Pharmacokinetics and Clinical Efficacy of MMAE Based Antibody Drug Conjugates
Region
| Japan |
Condition
Condition
Malignancy
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Obstetrics and Gynecology |
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the pharmacokinetics of unconjugated MMAE and the clinical outcomes in cancer patients initiating treatment with MMAE-based antibody-drug conjugates (ADCs), and to investigate their associations with patient-related factors, including CYP3A activity biomarkers, geriatric assessments, and body composition parameters. The aim of this study is to identify predictors of efficacy, safety, and treatment intensity of MMAE-based ADCs.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between plasma concentrations of unconjugated MMAE and the incidence of adverse events, particularly hematologic toxicities and peripheral neuropathy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be included:
1. Patients diagnosed with a malignant tumor
2. Patients initiating treatment with enfortumab vedotin, tisotumab vedotin, or polatuzumab vedotin
3. Patients aged 18 years or older
4. Patients who have provided written informed consent for participation in this study
Key exclusion criteria
Patients who meet any of the following criteria will be excluded:
1. Patients who are unable to provide written informed consent
2. Patients deemed inappropriate for inclusion in this study by the treating physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ikumi |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University School of Medicine Hospital
Division name
Department of Pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu-shi, Shizuoka, Japan
TEL
053-435-2111
suzukii@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Ikumi |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University School of Medicine Hospital
Division name
Department of Pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu-shi, Shizuoka, Japan
TEL
053-435-2111
Homepage URL
suzukii@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine Hospital
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu-shi, Shizuoka, Japan
Tel
053-435-2111
rinri@hama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 04 | Month | 22 | Day |
Last modified on
| 2026 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070043
