Elucidation of Factors Contributing to Interindividual Variability in Pharmacokinetics and Clinical Efficacy of MMAE Based Antibody Drug Conjugates

Elucidation of Factors Contributing to Interindividual Variability in Pharmacokinetics and Clinical Efficacy of MMAE Based Antibody Drug Conjugates - Elucidation of Factors Contributing to Interindividual Variability in Pharmacokinetics and Clinical Efficacy of MMAE Based Antibody Drug Conjugates

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061352

Enrollment

200

Registered

2026-04-22

Start date

2026-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignancy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Association between plasma concentrations of unconjugated MMAE and the incidence of adverse events, particularly hematologic toxicities and peripheral neuropathy	—

Countries

Japan

Contacts

Public ContactIkumi Suzuki

Hamamatsu University School of Medicine Hospital Department of Pharmacy

suzukii@hama-med.ac.jp053-435-2111

Outcome results