Phase I clinical trial - Phases précoces tumeurs solides
Phases précoces tumeurs solides
Ouvert depuis le: 03.03.2024
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.
Description de l'essai
The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of NI-1801, administered intravenously (IV) over 1 to 2 hour(s), 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.