Actively Recruiting
Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas
Led by OSE Immunotherapeutics · Updated on 2026-01-28
41
Participants Needed
11
Research Sites
362 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Signed and dated informed consent before study procedures
- ECOG performance status of 0 or 1
- Affiliated with a social security system or equivalent as per local rules
- Express HLA-A2 phenotype by validated blood test; additional HLA-A2 negative patients included in Part C
- Histologically or cytologically confirmed stage IV squamous or non-squamous NSCLC not eligible for surgery or radiation, without EGFR sensitizing mutation or ALK/ROS1 gene alterations eligible for targeted therapy
- PD-L1 expression by TPS 50% or higher (local assessment)
- No prior systemic therapy including immunotherapy in first-line metastatic setting; if neoadjuvant/adjuvant therapy, completed at least 6 months before metastatic diagnosis
- At least one measurable lesion per RECIST v1.1
- Adequate organ function: neutrophils ≥ 1.5 x 10^9/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 x 10^9/L, serum creatinine ≤ 1.5 times upper limit of normal (ULN) or creatinine clearance ≥ 30 mL/min, AST and ALT ≤ 3 ULN (≤ 5 ULN if liver metastasis), bilirubin ≤ 1.5 ULN (≤ 3 ULN total bilirubin or ≤ 1.5 ULN direct bilirubin for Gilbert's syndrome)
You will not qualify if you...
- Eligible for surgical resection or approved effective therapy; known hypersensitivity to OSE2101 or docetaxel components
- Previously treated with approved or investigational anti-PD-1/PD-L1 therapy
- Active autoimmune disease or history requiring systemic immunosuppressive treatment
- Participation in another clinical trial with a medicinal product
- Not recovered from adverse events greater than grade 1 from prior anticancer treatments, except grade 2 neuropathy or any grade alopecia
- Known additional malignancy progressing or needing active treatment, except basal cell carcinoma, squamous cell skin carcinoma, or in situ cervical cancer
- Active central nervous system metastases or carcinomatous meningitis; stable previously treated brain metastases allowed if no progression for 4 weeks and no steroids above 10 mg/day
- Active or history of non-infectious pneumonitis requiring steroids or interstitial lung disease
- Any condition or abnormality that could interfere with study results or participation
- Uncontrolled or symptomatic significant cardiovascular disease within 6 months prior to study drug administration including stroke, myocardial infarction, angina, arrhythmias, heart failure (NYHA class >2), or myocarditis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Institut Jules Bordet
Anderlecht, Belgium, 1070
Actively Recruiting
2
Antwerp University Hospital
Edegem, Belgium, 11013
Not Yet Recruiting
3
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
4
Hopital Saint Joseph
Paris, France, 75014
Actively Recruiting
5
Centre Eugène Marquis
Rennes, France, 35000
Completed
6
Institut de Cancerologie de l'Ouest
Saint-Herblain, France, 44805
Actively Recruiting
7
Oncopole
Toulouse, France, 31059
Actively Recruiting
8
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
9
University Hospital A Coruña Biomedical Research Institute (INIBIC)
A Coruña, Spain
Actively Recruiting
10
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI)
Girona, Spain, 17007
Actively Recruiting
11
Hospital Regional Universitario de Málaga
Málaga, Spain, 2901
Actively Recruiting
Research Team
S
Sylvie Jouve, PhD
CONTACT
S
Silvia Comis, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here