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 (Jun 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
Treatments studied
Other
Cancer type
Non-Hodgkin Lymphoma
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.
Frequently asked questions
Is NCT05751798 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require HLA-A?
Yes, HLA-A A2 phenotype is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR sensitizing mutation is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK fusion is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify