Rina-S for Gastrointestinal Cancer
(RAINFOL-09 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Study Official
Principal Investigator
Genmab
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Rina-S monotherapy for an average of 12 months, with 1 to 5 visits per 21-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may continue receiving Rina-S as long as the study is open and their cancer does not worsen
What Are the Treatments Tested in This Trial?
Interventions
- Rina-S
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants with GI cancer in cohorts A-E will receive Rina-S at the specified dose.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Genmab
Lead Sponsor
Dr. Jan van de Winkel
Genmab
Chief Executive Officer since 2010
PhD in Immunology, University of Utrecht
Dr. Judith Klimovsky
Genmab
Chief Medical Officer since 2019
MD, University of Copenhagen
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