Clinical trial • Not applicable • Oncology

TRASTUZUMAB DERUXTECAN for HER2-expressing or HER2-mutated advanced (unresectable or metastatic) solid tumors

Not applicable trial of TRASTUZUMAB DERUXTECAN for HER2-expressing or HER2-mutated advanced (unresectable or metastatic) solid tumors. 70 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
HER2-expressing or HER2-mutated advanced (unresectable or metastatic) solid tumors
Trial Stage
Not applicable
Drug Modality
ADC

Key dates

Initial CTIS Submission Date
27-10-2023
First CTIS Authorization Date
23-02-2024

Trial design

Not applicable trial across 14 sites in Belgium, France, Italy and others.

Target Sample Size
70

Eligibility

Recruits 70 The record indicates 'isVulnerablePopulationSelected': true. Informed consent must be signed and dated by the participant prior to any study-specific qualification procedures ("Sign and date the informed consent form, prior to the start of any study-specific qualification procedures and willing to comply with all study requirements"). Subject information and ICF materials in multiple languages are provided (documents include English, French, Spanish, Italian versions). No explicit description of assent or parental consent processes for minors is provided..

Pregnancy Exclusion
If the subject is a female of childbearing potential, she must have a negative urine pregnancy test at Screening, during the Treatment Period, and for 7 months, following the last dose of study drug.
Vulnerable Population
The record indicates 'isVulnerablePopulationSelected': true. Informed consent must be signed and dated by the participant prior to any study-specific qualification procedures ("Sign and date the informed consent form, prior to the start of any study-specific qualification procedures and willing to comply with all study requirements"). Subject information and ICF materials in multiple languages are provided (documents include English, French, Spanish, Italian versions). No explicit description of assent or parental consent processes for minors is provided.

Inclusion criteria

  • {"criterion_text":"- Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition\n- No evidence of progressive disease at screening and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s). Note: subjects receiving post-progression treatment (for parent protocols that permit it) are eligible provided they are stable, as determined by radiological evaluation obtained a maximum of 6 weeks prior to screening for this study and following consultation with the medical monitor.\n- Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug. Methods considered as highly effective methods of contraception can be found in Protocol Section 10.4.1. If the subject is a female of childbearing potential, she must have a negative urine pregnancy test at Screening, during the Treatment Period, and for 7 months, following the last dose of study drug. A female is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) with surgery at least 1 month before the first dose of study drug or confirmed by follicle stimulating hormone test\n- Male subjects must not freeze or donate sperm starting at Screening, throughout the study period, and at least 4 months after the final study drug administration.\n- Female subjects must not donate, or retrieve for their own use, ova from the time of Screening and throughout the Treatment Period in the compound-specific sub-protocol (Appendix A) and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time.\n- Sign and date the informed consent form, prior to the start of any study-specific qualification procedures and willing to comply with all study requirements"}

Exclusion criteria

  • {"criterion_text":"- Subjects who permanently discontinued from the study drug in the parent study.\n- Any AE, laboratory abnormality, or intercurrent illness that, in the opinion of the investigator, indicates study participation is not in the best interest of the subject.\n- Local access to commercially available drug at no cost to the subject as permitted by local/country regulation. Note: In countries where, according to local institutional requirements, it is not feasible to switch subjects to the commercial drug through prescription, even if fully reimbursed, subjects will be considered eligible to participate in the Rollover Study.\n- Subjects with any unresolved/ongoing AE(s) that meets the study drug discontinuation criteria\n- Subject 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"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- TEAEs leading to study drug discontinuation and/or dose reduction, treatment-emergent serious adverse events (TESAEs), and treatment-emergent adverse events of special interest (AESIs).","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
70
Recruitment Window Months
46
Consent Approach
Participants must sign and date an informed consent form prior to any study-specific qualification procedures. Subject information and ICF documents are provided in multiple languages (documents listed include English, French, Spanish, Italian versions and country-specific ICFs). No explicit assent or parental consent procedures for minors are described in the available records.

Geography

Total Number Of Sites
14
Total Number Of Participants
64

Belgium

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
14-01-2026
Processing Time Days
709
Number Of Sites
1
Number Of Participants
16

Sites

Site Name
Grand Hopital De Charleroi
Department Name
Medical Oncology
Contact Person Name
Jean-Luc Canon
Contact Person Email
jean-luc.canon@ghdc.be

France

Earliest CTIS Part Ii Submission Date
26-01-2024
Latest Decision Or Authorization Date
15-01-2026
Processing Time Days
720
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Institut Gustave Roussy
Department Name
Medical Oncology
Contact Person Name
David PLANCHARD
Site Name
Centre Oscar Lambret
Department Name
Medical Oncology
Contact Person Name
Farid El Hajbi
Contact Person Email
f-elhajbi@o-lambret.fr
Site Name
Timone University Hospital
Department Name
Medical Oncology
Contact Person Name
Marie Meurer
Contact Person Email
marie.meurer@ap-hm.fr
Site Name
Oncopole Claudius Regaud
Department Name
Medical Oncology
Contact Person Name
Julien Mazieres

Italy

Earliest CTIS Part Ii Submission Date
24-01-2024
Latest Decision Or Authorization Date
15-01-2026
Processing Time Days
722
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
Humanitas Mirasole S.p.A.
Department Name
Operative unit of oncology and ematology
Contact Person Name
Armando Santoro
Site Name
Istituto San Raffaele
Department Name
U.O.C. Oncologia Medica
Contact Person Name
Giampaolo Bianchini
Contact Person Email
bianchini.giampaolo@hsr.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Medical Oncology
Contact Person Name
Fabio Puglisi
Contact Person Email
fabio.puglisi@cro.it

Spain

Earliest CTIS Part Ii Submission Date
12-02-2024
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
704
Number Of Sites
6
Number Of Participants
16

Sites

Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Contact Person Name
Silvia Antolin Novoa
Contact Person Email
silvia.antolin.novoa@sergas.es
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Oncology
Contact Person Name
Farre (Xavier González)
Contact Person Email
xgfarre@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Adela Fernández Ortega
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Enriqueta Felip Font
Contact Person Email
efelip@vhio.net
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Luis Gonzaga Paz-Ares Rodriguez
Contact Person Email
lpazaresr@seom.org
Site Name
Hospital Universitario 12 De Octubre (additional entry)
Department Name
Oncology

Sponsor

Primary sponsor

Full Name
Daiichi Sankyo Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Suvoda LLC
Responsibilities
sponsorDuties codes: 3; contact: emclellan@suvoda.com
Name
Fortrea Inc.
Responsibilities
sponsorDuties codes: 10, 6; contact: tamil.raju@fortrea.com
Name
IQVIA Limited
Responsibilities
sponsorDuties codes: 12, 2, 5; contact: eu_clinical_trials_information@iqvia.com

Third parties

  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"sponsorDuties codes: 10, 6","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 12, 2, 5","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
DS-8201a
Active Substance
TRASTUZUMAB DERUXTECAN
Modality
ADC
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
prodAuthStatus = 1
Maximum Dose
204.8 mg/Kg milligram(s)/kilogram

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