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A Study of NI-1801 in Patients With Mesothelin Expressing Solid Cancers

Triple Negative Breast Cancer Clinical Trial

Official title:
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

Clinical Trial Summary

Study LCB-1801-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), first-in-human clinical study of NI-1801 in subjects with advanced, metastatic, or recurrent solid malignancies expressing mesothelin (MSLN). The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of NI-1801, administered intravenously (IV) to determine the maximum tolerated dose (MTD) and non-tolerated toxic dose (NTD) of both the first dose and subsequent doses of NI-1801. The expansion part (Part B) will further evaluate the safety and efficacy of NI-1801 administered at or below the MTD in up to 20 subjects in order to determine the recommended Phase 2 dose (RP2D). Treatments will be administered in 28-day cycles for up to 6 months until confirmed disease progression, unacceptable toxicity, or subject/Investigator decision to withdraw. NI-1801 treatment can extend beyond 6 cycles for those patients who do not have disease progression.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05403554
Study type Interventional
Source Light Chain Bioscience - Novimmune SA
Contact Clinical Project Manager
Phone +41 22 552 72 59
Email ni1801clinical@lightchainbio.com
Status Recruiting
Phase Phase 1
Start date April 29, 2022
Completion date September 30, 2025
View Details
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