Study on the Effectiveness and Safety of Rina-S for Advanced Gastrointestinal Cancers
Sponsor: Genmab
ClinicalTrials ID:NCT07539311
This clinical trial is testing a new treatment called Rina-S to see how well it works and how safe it is for people with advanced gastrointestinal cancers. The study will take place in various countries and involve up to 160 participants.
Patient Parameters
| Parameter | Options |
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Program Overview
This Phase 2 study aims to find out how effective Rina-S is in treating gastrointestinal (GI) cancers. Participants will receive Rina-S by itself, without any other cancer treatments. Everyone in the study will get the actual medication, not a placebo. Participants will need to visit the study site for tests and procedures, such as blood tests and imaging, to check the safety and effectiveness of the treatment. The study is expected to last about 22 months for each participant, including a treatment period of around 12 months. Participants will visit the clinic 1 to 5 times every 21 days. If the cancer does not worsen and there are no serious side effects, participants can continue the treatment as long as the study is ongoing.
Description
This is a Phase 2 trial to test the safety and effectiveness of Rina-S as a single treatment for people with gastrointestinal cancers that have worsened after standard treatments. The study will take place at multiple centers and involve different groups of participants. Researchers will also study how the body processes the drug and its effects on the body. Participants will need to have confirmed GI cancer that cannot be surgically removed or cured. They must have measurable cancer and show disease progression after their last treatment. Participants should be in good general health with a life expectancy of at least 3 months and must provide a tissue sample for testing. They will undergo regular tests to ensure their organs and bone marrow are functioning well before starting Rina-S.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of gastrointestinal cancer.
- Have cancer that has spread or cannot be removed by surgery.
- Have measurable cancer based on specific medical criteria.
- Show disease progression after the most recent treatment.
- Be in good general health with an ECOG performance status of 0 or 1.
- Have a life expectancy of at least 3 months.
- Be able to provide a tissue sample for testing.
- Have adequate organ and bone marrow function based on lab tests.
Exclusion Criteria
- Have significant non-cancerous gastrointestinal disorders, such as severe diarrhea or inflammatory bowel disease.
- Have had significant gastrointestinal bleeding or related issues in the past 4 to 6 weeks.
- Have another type of cancer or residual disease from a previous cancer.
- Have unstable or symptomatic brain metastases or a history of cancer spread to the brain lining.
- Have previously received a specific type of cancer treatment called topoisomerase-1 inhibitor ADC.
- Have received any cancer treatment within 28 days before starting the trial treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| START Midwest | 49546 | Grand Rapids | Michigan |
| START San Antonio | 78229 | San Antonio | Texas |
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