Testing OSE-279 for advanced solid tumors and 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

This study is testing a new treatment called OSE-279 to see if it can help people with advanced solid tumors or lymphomas who haven't had success with other therapies.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: OSE Immunotherapeutics (Industry-sponsored)
• Drugs / interventions: immunotherapy, radiation
• Locations: 11 sites (Anderlecht and 10 other locations)
• Trial ID: NCT05751798 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced solid tumors or lymphomas who have previously received systemic therapy and have no available standard of care.

Not a fit: Patients with early-stage tumors or those who have not received prior systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors and lymphomas who have limited treatment alternatives.

How similar studies have performed: Other studies using PD-1 blocking monoclonal antibodies have shown promising results, indicating that this approach has potential based on previous successes.

Eligibility criteria

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 this trial is running

Anderlecht and 10 other locations

• Institut Jules Bordet — Anderlecht, Belgium (Recruiting)
• Antwerp University Hospital — Edegem, Belgium (Not_yet_recruiting)
• Centre Léon Bérard — Lyon, France (Recruiting)
• Hopital Saint Joseph — Paris, France (Recruiting)
• Centre Eugène Marquis — Rennes, France (Completed)
• Institut de Cancerologie de l'Ouest — Saint-Herblain, France (Recruiting)
• Oncopole — Toulouse, France (Recruiting)
• Institut Gustave Roussy — Villejuif, France (Recruiting)
• University Hospital A Coruña Biomedical Research Institute (INIBIC) — A Coruña, Spain (Recruiting)
• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI) — Girona, Spain (Recruiting)
• Hospital Regional Universitario de Málaga — Málaga, Spain (Recruiting)

Study contacts

• Study coordinator: Sylvie Jouve, PhD

Conditions Solid Advanced Tumor; Lymphoma; NSCLC; Solid advanced tumor; Rare tumor; PD-L1 positive tumor; PD-1 blocking monoclonal antibody; Cancer vaccine