Gastrointestinal CancersPhase 2RAINFOL-09NCT07539311
Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) Cancers
A Phase 2 study testing Rina-S in people with Gastrointestinal Cancers, run by Genmab at 17 sites in 6 countries.
Trial summary
This Phase 2 study will be conducted in different countries around the world with up to about 160 participants. The purpose of this study is to evaluate how well Rina-S works against GI cancers. The medication in this study is Rina-S monotherapy (by itself; no other cancer treatments). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancers
- What is being tested?
- Rina-S
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 17 sitesin 6 countries
- Study dates
- 11 May 2026to Nov 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 6 countries
United States7 sites, 7 recruiting
- Recruiting
University of Colorado Hospitak Anschutz
Aurora, Colorado, 80045
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
- Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
- Recruiting
Greco-Hainsworth Center for Research
Nashville, Tennessee, 37203
- Recruiting
START San Antonio
San Antonio, Texas, 78229
- Recruiting
UCLA Hematology/Oncology, Santa Monica
Santa Monica, California, 90404
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Japan4 sites, 4 recruiting
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
- Recruiting
Cancer Institute Hospital of JFCR
Kōtoku, Tokyo-To, 135-8550
- Recruiting
The University of Osaka Hospital
Suita, Osaka, 565-0871
- Recruiting
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
Australia2 sites, 2 recruiting
- Recruiting
Cancer Research SA Pty Ltd
Adelaide, 5000
- Recruiting
St John of God Subiaco Hospital
Subiaco, Western Australia, 6008
France2 sites, 2 recruiting
- Recruiting
CHU Brest Cavale Blanche
Brest, Brittany (Bretagne), 29200
- Recruiting
Hôpital Saint-Antoine Onco Med
Paris, 75012
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
United Kingdom1 site, 1 recruiting
- Recruiting
Hammersmith Hospital
London, Greater London, W12 0HS
About this study
Official title: A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina S) in Participants With Advanced Gastrointestinal (GI) Cancers
This Phase 2 study will be conducted in different countries around the world with up to about 160 participants.
The purpose of this study is to evaluate how well Rina-S works against GI cancers.
Read more
The medication in this study is Rina-S monotherapy (by itself; no other cancer treatments). All participants will receive active drug; no one will be given placebo.
Participation in the study will require visits to the study site(s). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging/X-rays) to monitor whether the study treatment is safe and effective.
The duration of the study will be different for every participant, but an average study duration of 22 months is expected for participants. This will include a treatment period (expected to last an average of 12 months), plus data collection periods before and after treatment. Participants will be asked to attend 1 to 5 visits at the study clinic for each cycle (duration of an individual cycle is 21 days). If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.
Read the detailed description
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.
- Conditions
- Gastrointestinal Cancers
- Being tested
- Rina-S
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rina-SBiological
Also called Rinatabart sesutecan, GEN1184, PRO1184
Intravenous (IV) administration.
| Study group | Role | What they receive |
|---|---|---|
| Rina-S | Experimental | Participants with GI cancer in cohorts A-E will receive Rina-S at the specified dose. Receives: Biological: Rina-S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Objective Response Rate (ORR)
Measured: Up to approximately 22 months
Secondary outcomes (7)
Duration of Response (DOR)
Measured: Up to approximately 22 months
Disease Control Rate (DCR)
Measured: Up to approximately 22 months
Progression-free Survival (PFS)
Measured: Up to approximately 22 months
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Up to approximately 22 months
Maximum Concentration (Cmax) of Rina-S Related Analytes
Measured: Up to approximately 12 months
Area Under the Concentration-time Curve (AUC) of Rina-S Related Analytes
Measured: Up to approximately 12 months
Time to Reach Cmax (Tmax) of Rina-S Related Analytes
Measured: Up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start11 May 2026
- Primary completionSep 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancersStudies of the same condition, open and under way.
- More trials run by GenmabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Official, Study director, Genmab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539311
- Sponsor's protocol ID
- GCT1184-09
- Other IDs
- jRCT2051260087, 2025-524130-26, 2025
- Acronym
- RAINFOL-09
- Status last verified
- Oct 2026
- First submitted
- 13 Apr 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No