臨床研究等提出・公開システム

A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina S) in Participants With Advanced Gastrointestinal (GI) Cancers (RAINFOL-09)

Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) Cancers

jRCT Inquiry Receipt Center

IQVIA Services Japan G.K.

4-10-18 Takanawa, Minato-ku, Tokyo

JP-GCT1184-09_jRCT@iqvia.com

jRCT Inquiry Receipt Center

IQVIA Services Japan G.K.

4-10-18 Takanawa, Minato-ku, Tokyo

+81-3-6859-9500

JP-GCT1184-09_jRCT@iqvia.com

Recruiting

June. 23, 2026

Interventional

randomized controlled trial

open(masking not used)

dose comparison control

parallel assignment

treatment purpose

-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.
-Other protocol-defined inclusion criteria may apply.

-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.
-Other protocol-defined exclusion criteria may apply.

Both

Gastrointestinal Cancers

Participants with GI cancer in cohorts A-E will receive Rina-S at the specified dose by intravenous (IV) administration. All participants will receive active drug; no one will be given placebo.

Confirmed Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by Investigator

+81-6-6879-5111

June. 18, 2026

No

United States/Australia/Spain/France/Italy/Germany/UK/Belgium/Denmark/Netherlands/South Korea/Taiwan