This is a Phase 2, open-label, multicenter, multi-cohort trial to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics of Rina-S as monotherapy in participants with GI cancers who have progressed on or after prior standard of care (SoC) therapies.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) Cancers
