RecruitingPhase 1Phase 2NCT05751798

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

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


Sponsor

OSE Immunotherapeutics

Enrollment

41 participants

Start Date

Dec 20, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new immunotherapy drug called OSE-279 in patients with advanced solid tumors or lymphomas. In one part of the study, the focus is specifically on advanced non-small cell lung cancer (NSCLC) with high expression of PD-L1. The drug works by boosting the immune system's ability to recognize and attack cancer cells. **You may be eligible if...** - You are 18 or older - You have Stage IV non-squamous or squamous NSCLC without certain targetable gene mutations (EGFR, ALK, ROS1) - Your tumor has high PD-L1 expression (TPS ≥50%) - You have not had any prior systemic treatment in the first-line metastatic setting - You have at least one measurable tumor and adequate organ function **You may NOT be eligible if...** - Your cancer has EGFR, ALK, ROS1, or other targetable mutations - You have active autoimmune disease or are on chronic immunosuppressants - You are pregnant or breastfeeding - You have received prior immunotherapy for metastatic NSCLC Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPart A: OSE-279 100mg

Human IgG4 mAb against PD-1

DRUGPart A: OSE-279 300mg

Human IgG4 mAb against PD-1

DRUGPart A: OSE-279 600mg

Human IgG4 mAb against PD-1

DRUGPart B: OSE-279 600 mg and OSE2101

OSE-279: OSE-279: Human IgG4 mAb against PD-1 OSE2101: Cancer vaccine

DRUGPart C: OSE-279 600 mg and OSE2101 - HLA-A2 positive

OSE-279: Human IgG4 mAb against PD-1 OSE2101: Cancer vaccine

DRUGPart C: OSE-279 600 mg - HLA-A2 positif

OSE-279: Human IgG4 mAb against PD-1

DRUGPart C: OSE-279 600 mg - HLA-A2 negative

OSE-279: Human IgG4 mAb against PD-1


Locations(11)

Institut Jules Bordet

Anderlecht, Belgium

Antwerp University Hospital

Edegem, Belgium

Centre Léon Bérard

Lyon, France

Hopital Saint Joseph

Paris, France

Centre Eugène Marquis

Rennes, France

Institut de Cancerologie de l'Ouest

Saint-Herblain, France

Oncopole

Toulouse, France

Institut Gustave Roussy

Villejuif, France

University Hospital A Coruña Biomedical Research Institute (INIBIC)

A Coruña, Spain

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI)

Girona, Spain

Hospital Regional Universitario de Málaga

Málaga, Spain

View Full Details on ClinicalTrials.gov

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NCT05751798


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