Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOSE Immunotherapeutics
About this trial
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 criteria
Qualifiers
Signed and dated informed consent form (ICF) prior to any trialspecific procedures.
ECOG performance status 0-1
Patients must be affiliated to a social security system or an equivalent system, if applicable as per local regulations.
Patients expressing HLA-A2 phenotype on blood sample performed by an experienced laboratory using a validated test (PCR or NGS). Additional patients HLA-A2 negative will be included in PART C.
Disqualifiers
None
Trial design
Treatments tested in this trial
- Part A: OSE-279 100mg
- Part A: OSE-279 300mg
- Part A: OSE-279 600mg
- Part B: OSE-279 600 mg and OSE2101
- Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positive
- Part C: OSE-279 600 mg - HLA-A2 positif
- Part C: OSE-279 600 mg - HLA-A2 negative
Treatment groups
41 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Locations
11Belgium
Institut Jules Bordet1070, Anderlecht Belgium
Antwerp University Hospital11013, Edegem Belgium
France
Centre Léon Bérard69373, Lyon France
Hopital Saint Joseph75014, Paris France
Sponsors and collaborators
OSE Immunotherapeutics
Lead sponsor
Source ClinicalTrials.gov