Clinical trial • Phase III • Oncology

SACITUZUMAB TIRUMOTECAN for Gastric adenocarcinoma | Gastroesophageal junction adenocarcinoma | Esophageal adenocarcinoma

Phase III trial of SACITUZUMAB TIRUMOTECAN for Gastric adenocarcinoma | Gastroesophageal junction adenocarcinoma | Esophageal adenocarcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Gastric adenocarcinoma | Gastroesophageal junction adenocarcinoma | Esophageal adenocarcinoma
Trial Stage
Phase III
Drug Modality
ADC | Small molecule

Key dates

Initial CTIS Submission Date
15-02-2024
First CTIS Authorization Date
29-05-2024

Trial design

Randomised, open-label, treatment of physician's choice (tpc) including paclitaxel, trifluridine-tipiracil (trifluridine combinations), irinotecan, or docetaxel (doses/schedules per local practice; specific schedules not specified in provided record)-controlled Phase III trial across 34 sites in Denmark, Germany, Spain and others.

Randomised
Yes
Open Label
Yes
Comparator
Treatment of Physician's Choice (TPC) including paclitaxel, trifluridine-tipiracil (trifluridine combinations), irinotecan, or docetaxel (doses/schedules per local practice; specific schedules not specified in provided record)
Biomarker Stratified
True, biomarker: TROP2 status (strata not specified)
Target Sample Size
335

Stratification factors

  • TROP2 status

Eligibility

Recruits 335 No vulnerable population selected; participants are adults; informed consent is obtained from participants; no assent procedures are described..

Vulnerable Population
No vulnerable population selected; participants are adults; informed consent is obtained from participants; no assent procedures are described.

Inclusion criteria

  • {"criterion_text":"-Has a histologically- or cytologically-confirmed diagnosis of advanced, unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma.\n-Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology. Lesions situated in a previously-irradiated area are considered measurable if progression has been shown in such lesions.\n-Has received, and progressed on, at least 2 prior chemotherapy and/or immunotherapy regimens for advanced, unresectable or metastatic gastroesophageal adenocarcinoma.\n-Participants are eligible regardless of human epidermal growth factor receptor-2 (HER2) status. Participants who are HER2+ must have previously received trastuzumab where available/appropriate.\n-Has adequate organ function.\n-Has provided tumor tissue sample for determination of trophoblast cell-surface antigen 2 (TROP2) status by the central laboratory before randomization for stratification.\n-Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except for alopecia and vitiligo). Participants with endocrine related AEs who are adequately treated with hormone replacement therapy are eligible.\n-Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by the local site investigator/radiology.\n-Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days before randomization.\n-Has ability to swallow oral medication for those who may receive trifluridine-tipiracil.\n-Human immunodeficiency virus (HIV) infected participants must have well-controlled HIV on antiretroviral therapy (ART).\n-Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load.\n-Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable."}

Exclusion criteria

  • {"criterion_text":"-Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.\n-Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting study intervention is 2 weeks.\n-Has received an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.\n-Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n-Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n-Has an active infection requiring systemic therapy.\n-HIV infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castlemans’s Disease.\n-Has concurrent active hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and HCV (defined as anti- HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection.\n-Has had major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention. Anticipation of the need for major surgery during the course of treatment with study intervention is also exclusionary.\n-Has severe hypersensitivity (Grades ≥3) to the study interventions, any of their excipients, and/or to another biologic therapy.\n-Has a history of (noninfectious) pneumonitis/ interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.\n-Has Grade ≥2 peripheral neuropathy.\n-Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis, or chronic diarrhea).\n-Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of corrected QT interval (QTcF) to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention.\n-Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before the first dose of study intervention.\n-Has received prior treatment with a TROP2-targeted antibody drug conjugate (ADC), a topoisomerase 1 inhibitor-based ADC, and/or a topoisomerase 1 inhibitor-based chemotherapy.\n-Has received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention.\n-Has received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and/or has had radiation pneumonitis.\n-Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Overall Survival (OS)","definition_or_measurement_approach":"To compare MK-2870 to TPC with respect to OS"}

Secondary endpoints

  • {"endpoint_text":"-Progression-free Survival (PFS)","definition_or_measurement_approach":"Compare MK-2870 to TPC with respect to PFS per RECIST 1.1 as assessed by BICR"}
  • {"endpoint_text":"-Objective Response Rate (ORR)","definition_or_measurement_approach":"Compare MK-2870 to TPC with respect to ORR per RECIST 1.1 as assessed by BICR"}
  • {"endpoint_text":"-Duration of Response (DOR)","definition_or_measurement_approach":"Evaluate DOR per RECIST 1.1 as assessed by BICR in participants with confirmed CR or PR"}
  • {"endpoint_text":"-Number of Participants Who Experience an Adverse Event (AE)","definition_or_measurement_approach":"Standard AE reporting (number of participants experiencing AE)"}
  • {"endpoint_text":"-Number of Participants Who Discontinue Study Intervention Due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study intervention due to an AE"}

Recruitment

Planned Sample Size
335
Recruitment Window Months
36
Consent Approach
Informed consent is obtained from participants. Country-specific informed consent forms and subject information are provided (examples in documentation: Denmark [DA/EN], Germany [DE], Spain [ES], Poland [PL], France [FR], Belgium [EN/FR/NL], Italy [IT]). No assent procedures for minors are described.

Geography

Total Number Of Sites
34
Total Number Of Participants
117

Denmark

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
29-05-2024
Processing Time Days
27
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Aalborg University Hospital
Department Name
Oncology
Contact Person Name
Laurids Poulsen
Contact Person Email
laop@rn.dk
Site Name
Rigshospitalet
Department Name
Oncology
Contact Person Name
Lene Bæksgaard
Site Name
Odense University Hospital
Department Name
Oncology
Contact Person Name
Per Pfeiffer
Contact Person Email
per.pfeiffer@rsyd.dk

Germany

Earliest CTIS Part Ii Submission Date
13-05-2024
Latest Decision Or Authorization Date
29-05-2024
Processing Time Days
16
Number Of Sites
5
Number Of Participants
18

Sites

Site Name
Haematologisch Onkologische Praxis Eppendorf / Norddeutsches Studienzentrum für Innovative Onkologie
Department Name
Hämatologisch-Onkologische Praxis Eppendorf
Contact Person Name
Eray Goekkurt
Contact Person Email
goekkurt@hope-hamburg.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie
Contact Person Name
Annika Kurreck
Contact Person Email
annika.kurreck@charite.de
Site Name
Technische Universitat Dresden
Department Name
Medizinische Fakultät Carl Gustav Carus Medizinische Klinik und Poliklinik I
Contact Person Name
Gunnar Folprecht
Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik für Gastroenterologie, gastrointestinale Onkologie und Endokrinologie
Contact Person Name
Alexander Koenig
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
Contact Person Name
Georg Haag

Spain

Earliest CTIS Part Ii Submission Date
26-04-2024
Latest Decision Or Authorization Date
29-05-2024
Processing Time Days
33
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology department
Contact Person Name
Daniel Acosta Eyzaguirre
Contact Person Email
dacosta@vhio.net
Site Name
Hospital Universitario De Navarra
Department Name
Oncology department
Contact Person Name
Maria Alsina Maqueda
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncology department
Contact Person Name
Fernando Rivera Herrero
Contact Person Email
fernando.rivera@scsalud.es
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology department
Contact Person Name
Juan Cruz de la Camara Gomez
Site Name
Hospital Clinico San Carlos
Department Name
Oncology department
Contact Person Name
Beatriz García Paredes
Contact Person Email
begarpa@hotmail.com
Site Name
Hospital Universitario Central De Asturias
Department Name
Oncology department
Contact Person Name
Paula Jimenez Fonseca
Contact Person Email
palucaji@hotmail.com
Site Name
Hospital Universitario Marques De Valdecilla (duplicate entry in record?)
Department Name
Oncology department

Poland

Earliest CTIS Part Ii Submission Date
22-05-2024
Latest Decision Or Authorization Date
03-06-2024
Processing Time Days
12
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
sekretariat.odch@swk.med.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Lucjan Wyrwicz
Contact Person Email
lucjan.wyrwicz@nio.gov.pl

France

Earliest CTIS Part Ii Submission Date
06-05-2024
Latest Decision Or Authorization Date
03-06-2024
Processing Time Days
28
Number Of Sites
8
Number Of Participants
25

Sites

Site Name
Centre Oscar Lambret
Department Name
Oncology department
Contact Person Name
Farid EL HAJBI
Contact Person Email
f-elhajbi@o-lambret.fr
Site Name
Institut Bergonie
Department Name
Centre régional de lutte contre le cancer de la Nouvelle-Aquitaine_ oncologie médicale
Contact Person Name
Simon PERNOT
Contact Person Email
s.pernot@bordeaux.unicancer.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hôpital Saint-Louis _ Service d'Hépato-Gastro-Entérologie
Contact Person Name
Thomas APARICIO
Contact Person Email
thomas.aparicio@aphp.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Oncologie Médicale
Contact Person Name
Samuel LE SOURD
Contact Person Email
s.lesourd@rennes.unicancer.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Service Gastro-Entérologie et oncologie médicale
Contact Person Name
David TOUGERON
Contact Person Email
david.tougeron@chu-poitiers.fr
Site Name
Centre Leon Berard
Department Name
Oncologie Médicale
Contact Person Name
Clelia COUTZAC
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Hôpital Rangueil _ service d'oncologie médicale digestive
Contact Person Name
Rosine GUIMBAUD
Contact Person Email
guimbaud.r@chu-toulouse.fr
Site Name
Centre Francois Baclesse
Department Name
Unité de Recherche Clinique
Contact Person Name
Mélanie DOS SANTOS

Belgium

Earliest CTIS Part Ii Submission Date
03-05-2024
Latest Decision Or Authorization Date
30-05-2024
Processing Time Days
27
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Universite Catholique de Louvain
Department Name
Medical Oncology
Contact Person Name
Marc Van den Eynde
Site Name
UZ Leuven
Department Name
Digestieve Oncology
Contact Person Name
Jeroen Dekervel
Contact Person Email
jeroen.dekervel@uzleuven.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Treatment centre
Contact Person Name
Pieter Vandecandelaere
Site Name
Institut Jules Bordet
Department Name
Treatment centre
Contact Person Name
Ana-Maria Bucalau

Italy

Earliest CTIS Part Ii Submission Date
28-02-2024
Latest Decision Or Authorization Date
03-06-2024
Processing Time Days
96
Number Of Sites
5
Number Of Participants
18

Sites

Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
UOC Oncologia Medica
Contact Person Name
Ferdinando De Vita
Site Name
Universita Cattolica Del Sacro Cuore
Department Name
UOC Oncologia Medica
Contact Person Name
Giampaolo Tortora
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
U.O. Oncologia Medica 2
Contact Person Name
Lorenzo Fornaro
Contact Person Email
l.fornaro@ao-pisa.toscana.it
Site Name
Istituto Nazionale Dei Tumori
Department Name
Struttura Complessa Oncologia Medica 1
Contact Person Name
Filippo Pietrantonio
Site Name
Ospedale San Raffaele S.r.l.
Department Name
U.O. Oncologia Medica
Contact Person Name
Silvia Foti
Contact Person Email
foti.silvia@hsr.it

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
central imaging; other sponsor duties (codes 15 and 4 across entries)
Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Frontage Laboratories Inc.
Responsibilities
sponsor duties code 4
Name
Signant Health Global Solutions Limited
Responsibilities
sponsor duties code 3
Name
Eresearchtechnology Inc.
Responsibilities
sponsor duties code 7

Third parties

  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"central imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Roche Diagnostics GmbH","duties_or_roles":"sponsor duties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsor duties code 7","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"sponsor duties code 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Roche Tissue Diagnostics (Ventana Medical Systems)","duties_or_roles":"sponsor duties code 4","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"sponsor duties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited (second entry)","duties_or_roles":"sponsor duties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MK-2870
Active Substance
SACITUZUMAB TIRUMOTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Investigational medicinal product (MIA: IMP11011/00003)
Maximum Dose
4 mg/Kg (max daily dose amount indicated)
Investigational Product Name
PACLITAXEL
Active Substance
Paclitaxel
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Comparator, marketed (product status code 2)
Maximum Dose
80 mg/m2 (max daily dose amount indicated)
Investigational Product Name
TRIFLURIDINE, COMBINATIONS
Active Substance
Trifluridine (combination with tipiracil)
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Comparator, marketed (product status code 2)
Maximum Dose
70 mg/m2 (max daily dose amount indicated)
Investigational Product Name
IRINOTECAN
Active Substance
Irinotecan hydrochloride
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Comparator, marketed (product status code 2)
Maximum Dose
150 mg/m2 (max daily dose amount indicated)
Investigational Product Name
DOCETAXEL
Active Substance
Docetaxel
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Comparator, marketed (product status code 2)
Maximum Dose
75 mg/m2 (max daily dose amount indicated)

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