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Tests treatment safety and results for Gastrointestinal Cancers
Official title Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) Cancers
ClinicalTrials.gov ID: NCT07539311
What this study is testing
What is Rina-S?
Rina-S is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastrointestinal cancers.
Also referred to as Rinatabart sesutecan, GEN1184.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 22 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join if
- (all study cohorts):
- Participant has clinically significant non-malignant gastrointestinal disorders, including but not limited to, diarrhea \> grade 1, ulcerative...
- Participants with recent (up to 4 weeks) history of significant gastrointestinal bleeding, current cancer related ulcerations, fistula, abscess or...
- Participant has a past or current malignancy other than the inclusion diagnosis before the planned first dose of trial treatment, or any evidence of...
- Participants with newly identified or known unstable (eg, progressing brain metastases) or symptomatic central nervous system (CNS) metastases or...
- Prior treatment with topoisomerase-1 inhibitor containing antibody-drug conjugate (ADC).
See the full eligibility criteria
- 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. Key
- (all study cohorts):
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Grand Rapids, Michigan, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 22 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grand Rapids, Michigan, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.