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

NCT07539311 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-05-13

No results posted yet for this study

Summary

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

Interventions

BIOLOGICAL

Rina-S

Intravenous (IV) administration.

Sponsors & Collaborators

  • Genmab

    lead INDUSTRY

Principal Investigators

  • Study Official · Genmab

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-11
Primary Completion
2028-09-30
Completion
2028-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07539311 on ClinicalTrials.gov