CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 41 target
Drug / intervention
Part A: OSE-279 100mg +6 moredrug
Likely dose
Part A: OSE-279 100mgfrom record
Key inclusion· 8
  • ✓Age ≥18 years
  • ✓HLA-A2 phenotype (additional HLA-A2 negative patients in Part C)
  • ✓Stage IV NSCLC (squamous or non-squamous) not eligible for definite surgery/radiation, without EGFR/ALK/ROS1 mutations for which approved therapy exists
  • ✓PD-L1 expression by TPS ≥50% (local assessment)
Key exclusion· 10
  • ✕Eligible for surgical resection or another approved therapeutic regimen with clinical benefit
  • ✕Known hypersensitivity to OSE2101 or docetaxel
  • ✕Prior anti-PD-1/PD-L1 therapy
  • ✕Active autoimmune disease or documented history requiring systemic treatment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05751798
NCT05751798Phase 2RecruitingHigh Momentum
Long Recruiting
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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

OSE Immunotherapeutics·interventional·Posted Mar 2, 2023·Updated Jun 4, 2026

In Brief

A Phase 2 clinical trial evaluating Part A: OSE-279 100mg, Part A: OSE-279 300mg, and 5 other interventions for Solid Advanced Tumor and 2 related conditions. Currently recruiting, targeting 41 participants across 11 sites in 3 countries.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Advanced Tumor, Lymphoma, NSCLC (Non-small Cell Lung Cancer)
CountriesBelgium, France, Spain
Collaborators--

Timeline

Phase 2Recruiting
20232024202520262027202820292030
First PostedMar 2, 2023
Enrollment StartDec 20, 2022
Primary CompletionDec 1, 2029
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 3.3 years agoPrimary completion in 3.4 years

Interventions

Part A: OSE-279 100mgdrug

Human IgG4 mAb against PD-1

Part A: OSE-279 300mgdrug

Human IgG4 mAb against PD-1

Part A: OSE-279 600mgdrug

Human IgG4 mAb against PD-1

Part B: OSE-279 600 mg and OSE2101drug

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

Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positivedrug

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

Part C: OSE-279 600 mg - HLA-A2 positifdrug

OSE-279: Human IgG4 mAb against PD-1

Part C: OSE-279 600 mg - HLA-A2 negativedrug

OSE-279: Human IgG4 mAb against PD-1