Rina-S for advanced gastrointestinal cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• UCLA Hematology/Oncology, Santa Monica
  Santa Monica, California, United States Recruiting
• University of Colorado Hospitak Anschutz
  Aurora, Colorado, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• START Midwest
  Grand Rapids, Michigan, United States Recruiting
• Greco-Hainsworth Center for Research
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Genmab Trial Information
• Email: clinicaltrials@genmab.com
• Phone: +4570202728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.