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

Study acronym: RAINFOL-09
StatusRecruiting
PhasePhase 2
SponsorGenmab
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial sites expanded: 6 → 17 locations Eligibility criteria expanded, about 14 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 14 words
  2. Minor Study sites: 4 to 6v8
  3. Minor Study sites: 2 to 4v7
  4. Minor 3 versions Re-verified since Jun 1, 2026, no change to tracked fieldsv4-v6
  5. Minor Start date changed from estimate of May 2026 to May 11, 2026v3
  6. Notable Recruitment opened Study sites: 0 to 2v2 Show 1 more changeShow less
    • Study sites: 0 to 2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
45 trials monitored
See 3 trials at risk
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.
Trial Details
NCT Number NCT07539311
Lead Sponsor Genmab
Conditions Gastrointestinal Cancers
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov