Study of NEO-201 in Solid Tumors Expansion Cohorts

Summary

The open label, first-in-human, phase 1, dose escalation component in refractory solid tumors has been completed. The Maximum Tolerated Dose and Recommended Phase 2 Dose (RP2D) was determined to be 1.5mg/kg. The Expansion Phase of this study is currently enrolling subjects with non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), cervical and uterine cancers who progressed on front line therapy. Subjects will be treated with NEO-201 at the RP2D (1.5 mg/kg) every 2 weeks in combination with pembrolizumab, given 1 day after the NEO-201, at 400 mg IV every 6 weeks.

Timeline

Start

2019-01-18

Primary completion

2026-06-17

Completion

2026-11-30

Publications

• Cole CB, Morelli MP, Fantini M, Miettinen M, Fetsch P, Peer C, Figg WD, Yin T, Houston N, McCoy A, Lipkowitz S, Zimmer A, Lee JM, Pavelova M, Villanueva EN, Trewhitt K, Solarz BB, Fergusson M, Mavroukakis SA, Zaki A, Tsang KY, Arlen PM, Annunziata CM. First-in-human phase 1 clinical trial of anti-core 1 O-glycans targeting monoclonal antibody NEO-201 in treatment-refractory solid tumors. J Exp Clin Cancer Res. 2023 Mar 29;42(1):76. doi: 10.1186/s13046-023-02649-6.

Drugs

Indications