Phase 2 Study of Rina-S Monotherapy in Advanced Gastrointestinal Cancers
ClinicalTrials.gov Studies
Summary
The NIH has registered a Phase 2 clinical trial (NCT07539311) evaluating Rina-S monotherapy in approximately 160 participants with advanced gastrointestinal cancers. The single-arm study has no placebo arm; all participants receive active drug. The expected average participant duration is 22 months, including a 12-month treatment period with cycles of 21 days and 1-5 clinic visits per cycle.
What changed
This document registers a new Phase 2 clinical trial on ClinicalTrials.gov. The study evaluates Rina-S monotherapy for advanced gastrointestinal cancers across multiple international sites. All participants receive active study drug with no placebo comparator. Participants may continue treatment if cancer remains stable or improved and no serious adverse events occur.
Healthcare providers and patients considering clinical trial participation should note the study design: single-arm monotherapy, expected 12-month active treatment period, and periodic site visits (1-5 per 21-day cycle). No compliance obligations are created for external parties by this registration.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) Cancers
Phase 2 NCT07539311 Kind: PHASE2 Apr 20, 2026
Abstract
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.
Conditions: Gastrointestinal Cancers
Interventions: Rina-S
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