Testing OSE-279 for advanced solid tumors and lymphomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1/2 multicenter study evaluating OSE-279, a PD-1 blocking monoclonal antibody, in patients with advanced solid tumors or lymphomas. The study aims to determine the appropriate dosing of OSE-279 and assess its efficacy in patients who have not responded to standard treatments. Participants will receive varying doses of OSE-279 (100mg, 300mg, or 500mg) to identify the most effective dose for further development. The study focuses on patients with specific tumor types, including those with PD-L1 positive tumors or rare tumors that have shown activity with anti-PD-1 therapies.

Why it matters

Who can join: the full rules

Parts B and C - INCLUSION CRITERIA

1. Male or female, aged ≥ 18 years
2. Signed and dated informed consent form (ICF) prior to any trialspecific procedures.
3. ECOG performance status 0-1
4. Patients must be affiliated to a social security system or an equivalent system, if applicable as per local regulations.
5. 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.
6. Tumor type: a) Histologically or cytologically documented Stage IV squamous or non-squamous NSCLC not eligible for definite surgery or radiation, without EGFR sensitizing mutation or ALK and ROS1 gene alterations eligible for targeted therapy or other mutations for which an approved therapy exists in 1st line metastatic (see protocol); b) PD-L1 expression by TPS ≥ 50% (local)
7. Patients with 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.
8. Patients with at least one measurable lesion according to RECIST v1.1.
9. Adequate organ function:

   1. Bone marrow: neutrophils ≥ 1.5 x 109/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 x 109/L
   2. Renal function: serum creatinine ≤ 1.5 ULN or CKDEPI creatinine clearance ≥ 30 mL/min
   3. 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.

Parts B and C - NON-INCLUSION CRITERIA

1. Patient eligible to surgical resection or another approved therapeutic regimen known to provide clinical benefit; Known hypersensitivity to the active substances or to any of the excipients of OSE2101 or docetaxel.
2. Patient previously treated with approved/investigational anti-PD-1/PD-L1
3. Patient with active autoimmune disease or a documented history of autoimmune disease requiring systemic treatment (i.e., corticosteroids or immunosuppressive drugs); see exceptions in protocol
4. Patient participating in another clinical trial with a medicinal product
5. Patients who have not recovered from AEs (i.e. \> G1 according to CTCAE v5.0) due to prior treatment with anti-cancer agents with exception of G2 neuropathy or any Grade alopecia. (see protocol)
6. Patients with known additional malignancy progressing or requiring active treatment. Basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer are not non-inclusion criteria
7. Patients with known active central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to C1D1 and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids (at doses \> 10 mg/day methylprednisolone or equivalent) for 4 weeks prior C1D1
8. Patients with active or history of non-infectious pneumonitis requiring steroids, or interstitial lung disease
9. Patients with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the duration of the study
10. Patients with a history of uncontrolled or symptomatic, clinically significant cardiovascular disease: stroke, myocardial infarction, angina pectoris, arrhythmias, congestive heart failure (NYHA Class \>2), or myocarditis within 6 months prior to first study drug administration

Where it's running

• Institut Jules Bordet
  Anderlecht, Belgium Recruiting
• Antwerp University Hospital
  Edegem, Belgium Recruiting
• Centre Léon Bérard
  Lyon, France Recruiting
• Hopital Saint Joseph
  Paris, France Recruiting
• Institut de Cancerologie de l'Ouest
  Saint-Herblain, France Recruiting
• Oncopole
  Toulouse, France Recruiting

Study contacts

• Study coordinator: Sylvie Jouve, PhD
• Email: sylvie.jouve@ose-immuno.com
• Phone: +33 631 654 710

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.