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Clinical Trials in Spain / NCT05751798
Recruiting Phase 1/2

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

NCT05751798 · tracked via the Priya Life Science Spain tracker
Sponsor
OSE Immunotherapeutics
Phase
Phase 1/2
Started
2022-12-20
Last updated
2026-06-04

Condition(s) studied

Solid Advanced TumorLymphomaNSCLC (Non-small Cell Lung Cancer)

Investigational drug(s) / intervention(s)

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

Part A: OSE-279 100mg: Human IgG4 mAb against PD-1

Part A: OSE-279 300mg: Human IgG4 mAb against PD-1

Part A: OSE-279 600mg: Human IgG4 mAb against PD-1

Part B: OSE-279 600 mg and OSE2101: OSE-279: OSE-279: Human IgG4 mAb against PD-1 OSE2101: Cancer vaccine

Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positive: OSE-279: Human IgG4 mAb against PD-1 OSE2101: Cancer vaccine

Part C: OSE-279 600 mg - HLA-A2 positif: OSE-279: Human IgG4 mAb against PD-1

Part C: OSE-279 600 mg - HLA-A2 negative: OSE-279: Human IgG4 mAb against PD-1

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Parts B and C - INCLUSION CRITERIA 1. Male or female, aged ≥ 18 years 2. Signed and dated informed consent form (ICF) prior to any trialspecific procedures. 3. ECOG performance status 0-1 4. Patients must be affiliated to a social security system or an equivalent system, if applicable as per local regulations. 5. 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. 6. Tumor type: a) Histologically or cytologically documented Stage IV squamous or non-squamous NSCLC not eligible for definite surgery or radiation, without EGFR sensitizing mutation or ALK and ROS1 gene alterations eligible for targeted therapy or other mutations for which an approved therapy exists in 1st line metastatic (see protocol); b) PD-L1 expression by TPS ≥ 50% (local) 7. Patients with NO prior systemic therapy including immunotherapy in the first-line metastatic setting. In case of neoadjuvant/adjuvant therapy, therapy was completed at least 6 months prior to the diagnosis of metastatic disease. 8. Patients with at least one measurable lesion according to RECIST v1.1. 9. Adequate organ function: 1. Bone marrow: neutrophils ≥ 1.5 x 109/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 x 109/L 2. Renal function: serum creatinine ≤ 1.5 ULN or CKDEPI creatinine clearance ≥ 30 mL/min 3. Liver function: AST and ALT ≤ 3 ULN, bilirubin ≤ 1.5 ULN. In case of liver metastasis: AST and ALT ≤ 5 ULN. For patients with Gilbert's syndrome total bilirubin ≤ 3 ULN or direct bilirubin ≤ 1.5 ULN. Parts B and C - NON-INCLUSION CRITERIA 1. Patient eligible to surgical resection or another approved therapeutic regimen known to provide clinical benefit; Known hypersensitivity to the active substances or to any of the excipients of OSE2101 or docetaxel. 2. Patient previously treated with approved/investigational anti-PD-1/PD-L1 3. Patient with active autoimmune disease or a documented history of autoimmune disease requiring systemic treatment (i.e., corticosteroids or immunosuppressive drugs); see exceptions in protocol 4. Patient participating in another clinical trial with a medicinal product 5. Patients who have not recovered from AEs (i.e. \> G1 according to CTCAE v5.0) due to prior treatment with anti-cancer agents with exception of G2 neuropathy or any Grade alopecia. (see protocol) 6. Patients with known additional malignancy progressing or requiring active treatment. Basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer are not non-inclusion criteria 7. Patients with known active central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to C1D1 and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids (at doses \> 10 mg/day methylprednisolone or equivalent) for 4 weeks prior C1D1 8. Patients with active or history of non-infectious pneumonitis requiring steroids, or interstitial lung disease 9. Patients with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the duration of the study 10. Patients with a history of uncontrolled or symptomatic, clinically significant cardiovascular disease: stroke, myocardial infarction, angina pectoris, arrhythmias, congestive heart failure (NYHA Class \>2), or myocarditis within 6 months prior to first study drug administration

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Institut Jules Bordet Anderlecht Belgium Recruiting
Antwerp University Hospital Edegem Belgium Recruiting
Centre Léon Bérard Lyon France Recruiting
Hopital Saint Joseph Paris France Recruiting
Centre Eugène Marquis Rennes France Completed
Institut de Cancerologie de l'Ouest Saint-Herblain France Recruiting
Oncopole Toulouse France Recruiting
Institut Gustave Roussy Villejuif France Recruiting
University Hospital A Coruña Biomedical Research Institute (INIBIC) A Coruña Spain Recruiting
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI) Girona Spain Recruiting
Hospital Regional Universitario de Málaga Málaga Spain Recruiting

More OSE Immunotherapeutics trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05751798 on ClinicalTrials.gov ↗ ← All trials in Spain