Trials / Recruiting
RecruitingNCT05751798
Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas
A Multicenter, Phase 1/2, Dose-finding and Dose Expansion Study of OSE-279, a PD-1 Blocking Monoclonal Antibody, in Subjects With Advanced Solid Tumors or Lymphomas
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 41 (estimated)
- Sponsor
- OSE Immunotherapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
* The PART A objectives are to determine the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Doses (RP2D) when administered as single IV infusion on every 3 or 6 weeks. * The PART B objective is to evaluate the safety of the combination of OSE-279 administered at the RP2D (600mg Q6W) and OSE2101 at the therapeutic dose as 1st line treatment of metastatic (stage IV) NSCLC. * The PART C objective is to assess the antitumor activity of OSE-279 in combination with OSE2101 versus 0SE-279 in terms of overall response rate (ORR) as assessed locally, in patients with 1st line metastatic (stage IV) NSCLC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Part A: OSE-279 100mg | Human IgG4 mAb against PD-1 |
| DRUG | Part A: OSE-279 300mg | Human IgG4 mAb against PD-1 |
| DRUG | Part A: OSE-279 600mg | Human IgG4 mAb against PD-1 |
| DRUG | Part B: OSE-279 600 mg and OSE2101 | OSE-279: OSE-279: Human IgG4 mAb against PD-1 OSE2101: Cancer vaccine |
| DRUG | Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positive | OSE-279: Human IgG4 mAb against PD-1 OSE2101: Cancer vaccine |
| DRUG | Part C: OSE-279 600 mg - HLA-A2 positif | OSE-279: Human IgG4 mAb against PD-1 |
| DRUG | Part C: OSE-279 600 mg - HLA-A2 negative | OSE-279: Human IgG4 mAb against PD-1 |
Timeline
- Start date
- 2022-12-20
- Primary completion
- 2029-12-01
- Completion
- 2029-12-01
- First posted
- 2023-03-02
- Last updated
- 2026-01-28
Locations
11 sites across 3 countries: Belgium, France, Spain
Source: ClinicalTrials.gov record NCT05751798. Inclusion in this directory is not an endorsement.