Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) Cancers
Start Date
5/11/2026
Completion Date
11/1/2028
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.
Detailed Description
This is a Phase 2, open-label, multicenter, multi-cohort trial to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics of Rina-S as monotherapy in participants with GI cancers who have progressed on or after prior standard of care (SoC) therapies.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Rina-S
Conditions
Locations
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
UCLA Hematology/Oncology, Santa Monica
Santa Monica, California 90404
United States
University of Colorado Hospitak Anschutz
Aurora, Colorado 80045
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
START Midwest
Grand Rapids, Michigan 49546
United States
Greco-Hainsworth Center for Research
Nashville, Tennessee 37203
United States
START San Antonio
San Antonio, Texas 78229
United States
St John of God Subiaco Hospital
Subiaco, Western Australia 6008
Australia
Cancer Research SA Pty Ltd
Adelaide, 5000
Australia
CHU Brest Cavale Blanche
Brest, Brittany (Bretagne) 29200
France
Hôpital Saint-Antoine Onco Med
Paris, 75012
France
National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
Japan
Kanagawa Cancer Center
Yokohama, Kanagawa 241-8515
Japan
The University of Osaka Hospital
Suita, Osaka 565-0871
Japan
Cancer Institute Hospital of JFCR
Kōtoku, Tokyo-To 135-8550
Japan
Samsung Medical Center
Seoul, 06351
South Korea
Hammersmith Hospital
London, Greater London W12 0HS
United Kingdom