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Phase I study of the NI-1801 antibody targeting mesothelin x CD47, as a single agent and in combination with the anti-PD-1 antibody or with paclitaxel in patients with solid cancers.
THE OBJECTIVE OF THIS RESEARCH IS TO EVALUATE WHETHER THE STUDY DRUG NI-1801, AS A SINGLE AGENT, IN COMBINATION WITH PEMBROLIZUMAB, IN COMBINATION WITH PACLITAXEL (RANDOMIZED COHORT I), OR IN COMBINATION WITH PEMBROLIZUMAB AND STANDARD CHEMOTHERAPY-BASED TREATMENT WITH PACLITAXEL (RANDOMIZED COHORT II), HAS POTENTIAL BENEFICIAL EFFECTS AND IS SAFE FOR PATIENTS WITH THESE TYPES OF CANCER.
Technical Summary
- OPEN-LABEL, PHASE I DOSE-FINDING STUDY OF NI-1801, A BISPECIFIC ANTIBODY TARGETING MESOTHELIN X CD47, AS A SINGLE AGENT, IN COMBINATION WITH THE ANTI-PD-1 ANTIBODY, AND IN COMBINATION WITH ONCE-WEEKLY PACLITAXEL (STANDARD TREATMENT) IN PATIENTS WITH OVARIAN, PANCREATIC, NON-SMALL CELL LUNG, AND TRIPLE-NEGATIVE BREAST CANCER EXPRESSING MESOTHELIN; AND IN COMBINATION WITH THE ANTI-PD-1 ANTIBODY AND ONCE-WEEKLY PACLITAXEL, WITH OR WITHOUT BEVACIZUMAB, COMPARED WITH ONCE-WEEKLY PACLITAXEL, WITH OR WITHOUT BEVACIZUMAB, IN PATIENTS WITH PLATINUM-RESISTANT OVARIAN CANCER.
- Code EudraCT: 2021-003808-40
- Protocol number: LCB-1801-001
- Promoter: Novimmune
- Molecule/Drug: NI-1801
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