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

Sponsor
OSE Immunotherapeutics
Study ID
NCT05751798
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Lymphoma
  • NSCLC (Non-small Cell Lung Cancer)
  • Solid Advanced Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Part A: OSE-279 100mg — DRUG
    Human IgG4 mAb against PD-1
  • Part A: OSE-279 300mg — DRUG
    Human IgG4 mAb against PD-1
  • Part A: OSE-279 600mg — DRUG
    Human IgG4 mAb against PD-1
  • Part B: OSE-279 600 mg and OSE2101 — DRUG
    OSE-279: OSE-279: Human IgG4 mAb against PD-1 OSE2101: Cancer vaccine
  • Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positive — DRUG
    OSE-279: Human IgG4 mAb against PD-1 OSE2101: Cancer vaccine
  • Part C: OSE-279 600 mg - HLA-A2 positif — DRUG
    OSE-279: Human IgG4 mAb against PD-1
  • Part C: OSE-279 600 mg - HLA-A2 negative — DRUG
    OSE-279: Human IgG4 mAb against PD-1

Study Details

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.

Key Dates

Start date
Dec 20, 2022
Status verified
Jun 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
41 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: OSE-279 100 mg
    Part A: Dose Level 1: OSE-279 100 mg
  • Experimental: Part A: OSE-279 300 mg
    Part A: Dose Level 2: OSE-279 300 mg
  • Experimental: Part A: OSE-279 600 mg
    Part A: Dose Level 3: OSE-279 600 mg
  • Experimental: Part B: OSE-279 600 mg and OSE2101
    Part B: OSE-279 600 mg and OSE2101
  • Experimental: Drug: Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positif
    Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positive
  • Experimental: Part C: OSE-279 600 mg - HLA-A2 positif
    Part C: OSE-279 600 mg - HLA-A2 positif
  • Experimental: Part C: OSE-279 600 mg - HLA-A2 negative
    Part C: OSE-279 600 mg - HLA-A2 negative

Primary Outcome Measure

Part A: Occurrence of dose limiting toxicity (DLT). Part B: Safety and tolerability of the combination OSE-279/OSE2101. Part C: Overall response rate (ORR) of the combination OSE-279/OSE2101 [ Time Frame: Part A: DLT observation period is defined as the first 21 days after receiving the 1st injection of OSE-279 (Cycle 1) Part B: DLT observation period is defined as the first 6 weeks after receiving the combinaison Part C: Best response ]

Central Contacts

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