Trial intelligence / Profile preview

Rina-S in Advanced Gastrointestinal Cancers

NCT07539311Phase 2

Key facts

Status: Recruiting
Start: May 2026
Primary completion: Sep 2028
Countries: 11
Sponsor: Genmab
Modality: Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs), Small Molecules

Drugs: rinatabart sesutecan
Conditions: gastrointestinal cancer

Overview

Phase 2, open-label, single-arm trial of rinatabart sesutecan in gastrointestinal cancer, sponsored by Genmab. Primary endpoint: Confirmed Objective Response Rate at 22 months. Started May 2026; status: recruiting.

Design

1 arm

Study design: Non-randomizedOpen-label

Rina-S
Rina-S monotherapy

Who it enrols

Participants with histologically or cytologically confirmed metastatic or unresectable GI cancer, measurable disease per RECIST v1.1, radiological disease progression on/after most recent regimen, ECOG PS 0-1, life expectancy >=3 months. Excludes those with significant non-malignant GI disorders, recent GI bleeding/ulcerations/fistula/abscess/perforation, other malignancies, unstable CNS metastases, prior topoisomerase-1 inhibitor ADC, or anticancer treatment within 28 days.

Endpoints

Primary

Confirmed Objective Response Rate22 months

Secondary

Duration of Response22 months
Disease Control Rate22 months
Progression-free Survival22 months
Number of Participants with Treatment-emergent Adverse Events22 months
Maximum Concentration of Rina-S Related Analytes12 months
Area Under the Concentration-time Curve of Rina-S Related Analytes12 months
Time to Reach Cmax of Rina-S Related Analytes12 months

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