2025-524130-26-00RecruitingPhase 2
A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina S) in Participants With Advanced Gastrointestinal (GI) Cancers
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Genmab A/S
- Enrollment
- 67
- Locations
- 38
- Primary Endpoint
- Confirmed Objective Response Rate (ORR) per RECIST v1.1 as assessed by Investigator
Study Overview
Brief Summary
Evaluate the antitumor activity of Rina-S monotherapy in participants with metastatic colorectal cancer, gastric/gastroesophageal junction cancer or esophageal adenocarcinoma, pancreatic ductal adenocarcinoma, biliary tract cancer, and esophageal squamous cell carcinoma.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant has histologically or cytologically confirmed gastrointestinal 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
- •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
Exclusion Criteria
- •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.
Arms & Interventions
PEGFILGRASTIM
Auxiliary
Intervention: PEGFILGRASTIM (Drug)
Rinatabart Sesutecan
Test
Intervention: Rinatabart Sesutecan (Drug)
Outcomes
Primary Outcomes
Confirmed Objective Response Rate (ORR) per RECIST v1.1 as assessed by Investigator
Confirmed Objective Response Rate (ORR) per RECIST v1.1 as assessed by Investigator
Secondary Outcomes
- 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
Investigators
Genmab Trial Information
Scientific
Genmab A/S
Study Sites (38)
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