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

NCT07539311 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: GCT1184-092025-524130-26
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Gastrointestinal Cancers

Outcome Measures

Primary Outcomes (1)

• Confirmed Objective Response Rate (ORR)

  Up to approximately 22 months

Secondary Outcomes (7)

• Duration of Response (DOR)

  Up to approximately 22 months

• Disease Control Rate (DCR)

  Up to approximately 22 months

• Progression-free Survival (PFS)

  Up to approximately 22 months

• Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  Up to approximately 22 months

• Maximum Concentration (Cmax) of Rina-S Related Analytes

  Up to approximately 12 months

Study Arms (1)

Rina-S

EXPERIMENTAL

Participants with GI cancer in cohorts A-E will receive Rina-S at the specified dose.

Biological: Rina-S

Interventions

Rina-S BIOLOGICAL

Intravenous (IV) administration.

Also known as: Rinatabart sesutecan, GEN1184, PRO1184

Rina-S

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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).
• 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.

Sponsors & Collaborators

• Genmab: lead

Study Sites (2)

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

START San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Study Official

  Genmab

  STUDY DIRECTOR

Central Study Contacts

Genmab Trial Information

CONTACT

+4570202728; clinicaltrials@genmab.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)