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Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) Cancers
Sponsor: Genmab
Summary
This Phase 2 study will be conducted in different countries around the world with up to about 160 participants. The purpose of this study is to evaluate how well Rina-S works against GI cancers. The medication in this study is Rina-S monotherapy (by itself; no other cancer treatments). All participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging/X-rays) to monitor whether the study treatment is safe and effective. The duration of the study will be different for every participant, but an average study duration of 22 months is expected for participants. This will include a treatment period (expected to last an average of 12 months), plus data collection periods before and after treatment. Participants will be asked to attend 1 to 5 visits at the study clinic for each cycle (duration of an individual cycle is 21 days). If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.
Official title: A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina S) in Participants With Advanced Gastrointestinal (GI) Cancers
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2026-05-11
Completion Date
2028-11
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Rina-S
Intravenous (IV) administration.
Locations (28)
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA Hematology/Oncology, Santa Monica
Santa Monica, California, United States
University of Colorado Hospitak Anschutz
Aurora, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
START Midwest
Grand Rapids, Michigan, United States
Greco-Hainsworth Center for Research
Nashville, Tennessee, United States
START San Antonio
San Antonio, Texas, United States
GenesisCare St Leonards
Saint Leonards, New South Wales, Australia
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia
Cancer Research SA Pty Ltd
Adelaide, Australia
Cliniques Universitaires Saint-Luc | Cliniques Universitaires Saint-Luc|Head and Neck tumors, Route 407 | Cliniques Universitaires Saint-Luc|Hematology
Brussels, Belgium
Centre Hospitalier de l'Ardenne|Service Oncologie
Libramont, Belgium
CHU Brest Cavale Blanche
Brest, Brittany (Bretagne), France
Institut Régional du Cancer de Montpellier
Montpellier, Herault, France
Hôpital Européen Georges Pompidou
Paris, Paris, France
Centre Leon Berard
Lyon, Rhone, France
Hôpital Saint-Antoine Onco Med
Paris, France
Asklepios Klinik Altona
Hamburg, Free and Hanseatic City of Hamburg, Germany
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
The University of Osaka Hospital
Suita, Osaka, Japan
Cancer Institute Hospital of JFCR
Kōtoku, Tokyo-To, Japan
Amsterdam UMC, Locatie VUMC|Hematology
Amsterdam, Netherlands
Samsung Medical Center
Seoul, South Korea
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Taipei Veterans General Hospital
Taipei, Taiwan
University College London Hospitals
London, Greater London, United Kingdom
Hammersmith Hospital
London, Greater London, United Kingdom