Rina-S for advanced gastrointestinal cancers
A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina S) in Participants With Advanced Gastrointestinal (GI) Cancers
This Phase 2 trial will try Rina-S alone in people with metastatic or unresectable gastrointestinal cancers that have progressed after standard treatments to see if it can control the disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Genmab Industry-sponsored |
| Locations | 2 sites (Grand Rapids, Michigan and 1 other locations) |
| Trial ID | NCT07539311 on ClinicalTrials.gov |
What this trial studies
This is an open-label, multicenter, multi-cohort Phase 2 trial testing Rina-S as a single agent in participants with advanced GI cancers who have progressed on or after standard-of-care therapies. Up to about 160 participants worldwide will receive active Rina-S and attend regular clinic visits for safety labs, ECGs, imaging, and other assessments. The study includes evaluation of safety, efficacy, pharmacokinetics, and pharmacodynamics, with participants required to have measurable disease per RECIST v1.1 and ECOG performance status 0–1. Average participant follow-up is expected to be about 22 months, with an average treatment duration of about 12 months.
Who should consider this trial
Good fit: Adults with histologically confirmed metastatic or unresectable gastrointestinal cancer, measurable disease per RECIST v1.1, ECOG 0–1, adequate organ and marrow function, and disease progression after prior standard therapies are the intended participants.
Not a fit: Patients with significant non-malignant gastrointestinal disorders (for example, diarrhea > grade 1), poor organ function, ECOG >1, or who are candidates for curative treatment are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, Rina-S could shrink tumors or slow disease progression for people with advanced GI cancers who have exhausted standard treatments.
How similar studies have performed: Previous single-agent targeted or immune therapies in advanced GI cancers have produced meaningful responses in selected molecular subgroups but have shown variable results across tumor types.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: • All study cohorts * Participant has histologically or cytologically confirmed GI cancer. * Participant has documented metastatic or unresectable disease, not amenable to treatment with curative intent. * Participant has measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at baseline. * Participant must have radiological disease progression while on or after receiving the most recent regimen. * Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Participant has life expectancy ≥3 months. * Participant must be able to provide a newly obtained or archival tissue sample. * Participant must have adequate organ and bone marrow function, per laboratory test results prior to Rina-S administration. Key Exclusion Criteria (all study cohorts): * Participant has clinically significant non-malignant gastrointestinal disorders, including but not limited to, diarrhea \> grade 1, ulcerative colitis, inflammatory bowel disease. * Participants with recent (up to 4 weeks) history of significant gastrointestinal bleeding, current cancer related ulcerations, fistula, abscess or recent perforation (within 4 to 6 weeks). * Participant has a past or current malignancy other than the inclusion diagnosis before the planned first dose of trial treatment, or any evidence of residual disease from a previously diagnosed malignancy. * Participants with newly identified or known unstable (eg, progressing brain metastases) or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis (also known as leptomeningeal disease). * Prior treatment with topoisomerase-1 inhibitor containing antibody-drug conjugate (ADC). * Treatment with an anticancer agent within 28 days prior to the first dose of trial treatment. Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Where this trial is running
Grand Rapids, Michigan and 1 other locations
- START Midwest — Grand Rapids, Michigan, United States (Recruiting)
- START San Antonio — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Genmab Trial Information
- Email: clinicaltrials@genmab.com
- Phone: +4570202728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.