Phase 1 Study of NI-1801 Alone and With Anti-PD-1 or Paclitaxel in Patients With Mesothelin-Positive Advanced Ovarian, Pancreatic, Lung, and Triple-Negative Breast Cancers

What this Trial Is About

Researchers are evaluating NI-1801, a bispecific antibody targeting mesothelin and CD47, in patients with advanced, metastatic, or recurrent solid tumors that express mesothelin. This Phase 1, open-label study includes dose escalation and expansion phases to determine the safety, tolerability, and recommended dose of NI-1801, both alone and in combination with an anti-PD-1 antibody. A randomized cohort specifically targets patients with platinum-resistant ovarian cancer to compare NI-1801 plus paclitaxel against standard paclitaxel treatment. Treatments are given in 28-day cycles for up to 12 months or until disease progression, unacceptable side effects, or withdrawal. The study includes multiple groups NI-1801 alone at escalating doses, NI-1801 combined with pembrolizumab anti-PD-1 antibody, and a randomized cohort where patients receive either NI-1801 plus weekly paclitaxel or paclitaxel alone. Dosing schedules involve biweekly or adjusted intervals, and pembrolizumab is given every 6 weeks. Participants will undergo biopsies, tumor assessments, and monitoring of side effects and treatment response throughout the study. Researchers will measure dose-limiting toxicities, maximum tolerated dose, progression-free survival, and adverse events over up to 12 months. Additional evaluations include response rates, duration of response, pharmacokinetics, and biomarker analyses. Safety follow-up and adherence to study procedures are maintained during treatment and observation periods.

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