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

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
Genmab
Study ID
NCT07539311
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gastrointestinal Cancers

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rina-S — BIOLOGICAL
    Intravenous (IV) administration.

Study Details

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 Dates

Start date
May 11, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rina-S
    Participants with GI cancer in cohorts A-E will receive Rina-S at the specified dose.

Primary Outcome Measure

Confirmed Objective Response Rate (ORR) [ Time Frame: Up to approximately 22 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
START MidwestGrand RapidsMichigan49546-
START San AntonioSan AntonioTexas78229-

Find similar trials in Grand Rapids, MI

By research site
START Midwest· Grand Rapids, MISTART San Antonio· San Antonio, TX

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