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Clinical Trials in Italy / NCT06174987
Recruiting Phase 3

A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

NCT06174987 · tracked via the Priya Life Science Italy tracker
Sponsor
Daiichi Sankyo
Phase
Phase 3
Started
2024-01-05
Last updated
2025-10-15

Condition(s) studied

Advanced CancerMetastatic Cancer

Investigational drug(s) / intervention(s)

T-DXd →

T-DXd: T-DXd (DS8201a) will be administered as an intravenous (IV) infusion, on Day 1 of each 21-day cycle according to the dosage regimens

Study summary

This open-label, multicenter, rollover study will provide continued treatment for participants deriving benefit from different therapies received in studies sponsored by Daiichi Sankyo, Inc. (DS) or DS/Astra Zeneca (AZ)-sponsored study (eg. DS8201-A-J101, DS8201-A-U201, DS8201-A-U204, DS8201-A-U207, DS8201-A-U303).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Signed informed consent form, prior to the start of any study-specific qualification procedures and willing to comply with all study requirements. * Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition. * No evidence of progressive disease and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s). Exclusion Criteria: * Participants with any unresolved/ongoing AE(s) that meets the study drug discontinuation criteria * Participant who has been off T-DXd therapy for \>18 weeks (126 days) between the last dose from the parent study and the initiation of study drug administration on this study

Primary outcome measure(s)

  • Number of Participants Reporting Treatment-emergent Adverse Events Leading to Study Drug discontinuation and/or Dose Reduction, Treatment-emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (AESIs) — Baseline until disease progression, loss of clinical benefit, death, adverse event, pregnancy, withdrawal of consent, access to commercial supply, physician decision, or study closure, whichever occurs first, up to approximately 2 years 9 months

Trial sites (28)

FacilityCityRegionStatus
Miami Cancer Institute Miami Florida Recruiting
Duke University - Trent Center Durham North Carolina Recruiting
Flinders Medical Center Bedford Park Australia Active Not Recruiting
Monash Medical Center Melbourne Australia Withdrawn
Grand Hôpital de Charleroi Charleroi Belgium Recruiting
Instituto Aericas Rio de Janeiro Brazil Not Yet Recruiting
A.C. Camargo Cancer Center São Paulo Brazil Not Yet Recruiting
IBCC Nucleo de Pequisa e Ensino São Paulo Brazil Not Yet Recruiting
Institut Gustave Roussy Villejuif France Recruiting
Rabin Medical Center Petah Tikva Israel Active Not Recruiting
Ospedale San Raffaele Milan Italy Recruiting
Istituto Nazionale Tumori Fondazione G. Pascale Naples Italy Withdrawn
National Cancer Center Hospital Chūō Japan Recruiting
Kyungpook National University Chilgok Hospital Daegu South Korea Recruiting
National Cancer Center Gyeonggi-do South Korea Recruiting
Seoul National University Bundang Hospital Gyeonggi-do South Korea Withdrawn
Seoul National University Hospital Jongno-gu South Korea Recruiting
Severance Hospital, Yonsei University Seoul South Korea Recruiting
Asan Medical Center Seoul South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Complejo Hospitalario Universitario A Coruña A Coruña Spain Recruiting
Hospital Universitari Vall d'Hebron Barcelona Spain Recruiting
Hospital Universitari Dexeus Distrito de Les Corts Spain Not Yet Recruiting
ICO l'Hospitalet - Hospital Duran i Reynals L'Hospitalet de Llobregat Spain Recruiting
Hospital Ruber Internacional Madrid Spain Withdrawn
National Cheng Kung University Hospital Tainan Taiwan Withdrawn
National Taiwan University Hospital Taipei Taiwan Withdrawn
Royal Surrey County Hospital Guildford United Kingdom Withdrawn

More Daiichi Sankyo trials in Italy

Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01) Recruiting
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors Recruiting
Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07) Active, not recruiting
A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01) Active, not recruiting
Datopotamab Deruxtecan (Dato-DXd) in Combination With Pembrolizumab With or Without Platinum Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung02) Active, not recruiting

Other trials for the same condition

APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Recruiting
Liver Embolization Approaches for Tumor Management Recruiting
(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors Recruiting
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) Recruiting
Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06174987 on ClinicalTrials.gov ↗ ← All trials in Italy