Phase 1 study of DS-8201a in subject with Advanced Solid Malignant Tumors

A Phease1, Multicenter, Open-Label, Single Sequence Crossover Study to Evaluate Drug-Drug Interaction Potential of OATP1B/CYP3A Inhibitor on The Pharmacokinetics of DS-8201a in Subjects with HER2-Expressing Advanced Solid Malignant Tumors

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223734

Enrollment

Registered

2017-11-29

Start date

2018-01-24

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

Advanced Solid Malignant Tumors

Interventions

investigational material(s) Generic name etc : DS-8201a INN of investigational material : trastuzumab deruxtecan Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Inv

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Has a pathologically documented unresectable or metastatic solid malignant tumors with HER2 expression (determined by immunohistochemistry [IHC]/in situ hybridization [ISH] [IHC 3+, IHC 2+, IHC 1+, and/or ISH +], Next Generation Sequencing, or other analysis techniques as appropriate) that is refractory to or intolerable with at least 1 prior systemic chemotherapy regimen, or for which no standard treatment is available. 2. LVEF >= 50% . 3. Has an ECOG PS 0 or 1.

Exclusion criteria

Exclusion criteria: 1.Has a contraindication for receiving ritonavir or itraconazole according to the prescribing information. 2.Has a medical history of myocardial infarction within 6 months before enrollment, symptomatic congestive heart failure. 3.Has complications of ventricular arrhythmia

Design outcomes

Primary

Measure	Time frame
pharmacokinetics - PK parameters of DS-8201a and MAAA-1181a (with/without ritonavir) - PK parameters of DS-8201a and MAAA-1181a (with/without itraconazole) - PK parameters (Cmax and AUC0-17d) of DS-8201a and MAAA-1181a (with/without ritonavir) - PK parameters (Cmax and AUC0-17d) of DS-8201a and MAAA-1181a (with/without itraconazole)	—

Secondary

Measure	Time frame
safety efficacy pharmacogenomics - Serious adverse events (SAEs) - Treatment emergent adverse event - Discontinuation due to AE - Discontinuation due to adverse events of special interest (AESIs) - Physical examination findings (including Eastern Cooperative Oncology Group Performance Status [ECOG PS]) - Vital sign measurements - Standard clinical laboratory parameters - 12-lead ECG parameters - ECHO or MUGA findings - Ophthalmologic findings - Anti-drug antibodies Follow the Clinical Study Protocol	—

Measure

Time frame

safety efficacy pharmacogenomics - Serious adverse events (SAEs) - Treatment emergent adverse event - Discontinuation due to AE - Discontinuation due to adverse events of special interest (AESIs) - Physical examination findings (including Eastern Cooperative Oncology Group Performance Status [ECOG PS]) - Vital sign measurements - Standard clinical laboratory parameters - 12-lead ECG parameters - ECHO or MUGA findings - Ophthalmologic findings - Anti-drug antibodies Follow the Clinical Study Protocol

—

Countries

Asia except Japan, Japan

Contacts

Public ContactContact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp+81-3-6225-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026