clinical trial · NCT05751798

Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas

OSE Immunotherapeutics·phase2·recruiting·n = 41

Solid Advanced TumorLymphomaNSCLC (Non-small Cell Lung Cancer)Part A: OSE-279 100mgPart A: OSE-279 300mgPart A: OSE-279 600mgPart B: OSE-279 600 mg and OSE2101Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positivePart C: OSE-279 600 mg - HLA-A2 positifPart C: OSE-279 600 mg - HLA-A2 negative

brief summary

This is a phase 1/2, multicenter, dose-finding and dose expansion study of OSE-279, a PD-1 blocking monoclonal antibody, in subjects with advanced solid tumors or lymphomas.

started

Dec 20, 2022

primary completion

Dec 1, 2029

completion

Dec 1, 2029

last updated

Jan 28, 2026

detailed description

* The PART A objectives are to determine the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Doses (RP2D) when administered as single IV infusion on every 3 or 6 weeks. * The PART B objective is to evaluate the safety of the combination of OSE-279 administered at the RP2D (600mg Q6W) and OSE2101 at the therapeutic dose as 1st line treatment of metastatic (stage IV) NSCLC. * The PART C objective is to assess the antitumor activity of OSE-279 in combination with OSE2101 versus 0SE-279 in terms of overall response rate (ORR) as assessed locally, in patients with 1st line metastatic (stage IV) NSCLC.

official title

A Multicenter, Phase 1/2, Dose-finding and Dose Expansion Study of OSE-279, a PD-1 Blocking Monoclonal Antibody, in Subjects With Advanced Solid Tumors or Lymphomas

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