Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) Cancers
Recruiting now · Phase 2
Conditions studied: Gastrointestinal Cancers
In brief
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.
Key facts
- Study ID
- NCT07539311
- Run by
- Genmab
- People needed
- 160
- Starts
- 2026-05-11
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2026-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- START Midwest — Grand Rapids, Michigan, United States (enrolling)
- START San Antonio — San Antonio, Texas, United States (enrolling)
- The University of Osaka Hospital — Suita-shi, Osaka, Japan (enrolling)
- Cancer Institute Hospital of JFCR — Kōtoku, Tokyo-To, Japan (enrolling)
Full record on ClinicalTrials.gov
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