Brightline-1: Comparing Brigimadlin (BI 907828) and Doxorubicin for Treating Dedifferentiated Liposarcoma
Sponsor: Boehringer Ingelheim
ClinicalTrials ID:NCT05218499
This study is for adults with advanced dedifferentiated liposarcoma, a type of cancer. It compares a new drug, brigimadlin (BI 907828), with doxorubicin, a standard cancer treatment, to see which is more effective.
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Program Overview
The study is designed for people with advanced dedifferentiated liposarcoma, a type of cancer that cannot be surgically removed. Participants must be 18 or older and not receiving other cancer treatments. The study compares two treatments: brigimadlin (BI 907828), a new drug being tested, and doxorubicin, a standard cancer medication. Participants will receive either brigimadlin in tablet form or doxorubicin through an IV every three weeks. If doxorubicin is not effective, participants can switch to brigimadlin. The treatment will continue as long as it is beneficial and tolerable. Doctors will regularly monitor the tumor size and check for any spread of the cancer, as well as the participants' overall health and any side effects.
Eligibility Criteria
Inclusion Criteria
- Must provide signed consent to participate.
- Must be 18 years or older.
- Women who can have children and men who can father children must use two reliable birth control methods during the study and for a specified time after.
- Must have advanced or spreading dedifferentiated liposarcoma that cannot be surgically removed.
- Must have a confirmed diagnosis of dedifferentiated liposarcoma with specific genetic markers.
- Must have at least one tumor that can be measured by scans.
- Must be in good general health with an ECOG performance status of 0 or 1.
- Must be willing to provide blood samples and undergo a tumor biopsy.
- Must have adequate organ function.
Exclusion Criteria
- Cannot have a known TP53 gene mutation.
- Cannot have had major surgery within 4 weeks before starting the study or plan major surgery within 6 months.
- Cannot have had previous systemic therapy for liposarcoma.
- Cannot have had other cancers treated in the last 5 years, except for certain skin cancers or other cancers considered cured.
- Cannot have had previous treatment with anthracyclines.
- Cannot be taking medications that interfere with the study.
- Cannot be in another clinical trial or have been in one within the last 30 days.
- Cannot have conditions that would prevent following the study protocol, such as substance abuse.
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