OncoMatch/Clinical Trials/NCT05751798
Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas
Is NCT05751798 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for solid advanced tumor.
Treatment: 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 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: HLA-A A2 phenotype
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.
Required: EGFR sensitizing mutation
without EGFR sensitizing mutation ... eligible for targeted therapy
Required: ALK fusion
without ... ALK ... gene alterations eligible for targeted therapy
Required: ROS1 fusion
without ... ROS1 gene alterations eligible for targeted therapy
Required: PD-L1 (CD274) TPS ≥ 50% (TPS ≥ 50%)
PD-L1 expression by TPS ≥ 50% (local)
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: neoadjuvant/adjuvant therapy completed at least 6 months prior to diagnosis of metastatic disease
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.
Cannot have received: anti-PD-1/PD-L1 therapy
Patient previously treated with approved/investigational anti-PD-1/PD-L1
Lab requirements
Blood counts
neutrophils ≥ 1.5 x 10^9/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 x 10^9/L
Kidney function
serum creatinine ≤ 1.5 ULN or CKDEPI creatinine clearance ≥ 30 mL/min
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.
Adequate organ function: Bone marrow: neutrophils ≥ 1.5 x 10^9/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 x 10^9/L; Renal function: serum creatinine ≤ 1.5 ULN or CKDEPI creatinine clearance ≥ 30 mL/min; 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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