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Clinical trial of nadunolimab in combination with gemcitabine and carboplatin in patients with advanced triple-negative breast cancer.
THE OBJECTIVE OF THIS STUDY IS IN PHASE IB: TO ENSURE THAT THE COMBINATION OF THESE 3 DRUGS IS SAFE AND TO DETERMINE WHICH IS THE HIGHEST DOSE OF NADUNOLIMAB THAT CAN BE GIVEN SAFELY WITHOUT CAUSING SERIOUS SIDE EFFECTS; AND IN PHASE II: TO EVALUATE THE EFFICACY OF THE DIFFERENT COMBINATIONS BASED ON THE PERCENTAGE OF PATIENTS WITH REDUCTION AND/OR DISAPPEARANCE OF TUMOR SIZE AFTER TREATMENT.
Technical Summary
- PHASE 1B/2, OPEN-LABEL, RANDOMIZED, NON-COMPARATIVE PHASE 1B/2 STUDY OF NADUNOLIMAB IN COMBINATION WITH GEMCITABINE AND CARBOPLATIN IN PATIENTS WITH ADVANCED TRIPLE-NEGATIVE BREAST CANCER. TRIFOUR¿ STUDY. IMMUNOTHERAPY.
- Code EudraCT: 2021-003402-46
- Protocol number: CAN04CLIN005
- Promoter: CANTARGIA AB
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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