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DRUG:

NI-1801

i
Other names: NI-1801, NI 1801, NI1801
Associations
Company:
Light Chain Biosci
Drug class:
CD47 inhibitor, Mesothelin inhibitor
Related drugs:
Associations
3ms
A Study of NI-1801 in Patients with Mesothelin Expressing Solid Cancers (clinicaltrials.gov)
P1, N=70, Recruiting, Light Chain Bioscience - Novimmune SA | N=40 --> 70 | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Jun 2025 --> May 2026
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
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MSLN (Mesothelin)
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MSLN expression
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Keytruda (pembrolizumab) • paclitaxel • NI-1801
2years
A Phase 1, open-label, dose finding study of NI-1801, a bispecific mesothelin x CD47 engaging antibody, in patients with mesothelin expressing solid cancers (SITC 2022)
Adverse events are assessed according to CTCAE v5, tumor response is determined according to RECIST 1.1. Key inclusion criteria include (1) histologically or cytologically confirmed diagnosis of epithelial ovarian cancer (high-grade serous or endometroid), triple-negative breast cancer, or non-squamous non-small cell lung cancer, (2) advanced, metastatic, or recurrent disease, and (3) MSLN expression with staining intensity of ≥2+ as per immunohistochemistry in ≥60% of tumor cells.
Clinical • P1 data • IO biomarker
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MSLN (Mesothelin) • CD47 (CD47 Molecule)
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MSLN expression • MSLN positive
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NI-1801
over2years
New P1 trial
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MSLN (Mesothelin)
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MSLN expression
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NI-1801