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A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina S) in Participants With Advanced Gastrointestinal (GI) Cancers

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524130-26-00
Enrollment
53
Registered
2026-08-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Cancers

Brief summary

Confirmed Objective Response Rate (ORR) per RECIST v1.1 as assessed by Investigator

Detailed description

Duration of Response (DOR) per RECIST v1.1 as assessed by Investigator, Disease Control Rate (DCR) per RECIST v1.1 as assessed by Investigator, Progression-free Survival (PFS) per RECIST v1.1 as assessed by Investigator, Types and incidence and severity of h Treatment-emergent Adverse Events (TEAEs), PK parameters of Rina-S related analytes

Interventions

DRUGPEGFILGRASTIM

Sponsors

Genmab A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Secondary

MeasureTime frame
Duration of Response (DOR) per RECIST v1.1 as assessed by Investigator, Disease Control Rate (DCR) per RECIST v1.1 as assessed by Investigator, Progression-free Survival (PFS) per RECIST v1.1 as assessed by Investigator, Types and incidence and severity of h Treatment-emergent Adverse Events (TEAEs), PK parameters of Rina-S related analytes

Primary

MeasureTime frame
Confirmed Objective Response Rate (ORR) per RECIST v1.1 as assessed by Investigator

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 28, 2026