Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07539311
PHASE2

Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) Cancers

Sponsor: Genmab

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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