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

NCT ID: NCT05751798

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-20
• Study Completion Date: 2029-12-31

Brief 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

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A: OSE-279 100 mg

Part A: Dose Level 1: OSE-279 100 mg

Group Type: EXPERIMENTAL

Part A: OSE-279 100mg

Intervention Type: DRUG

Human IgG4 mAb against PD-1

Part A: OSE-279 300 mg

Part A: Dose Level 2: OSE-279 300 mg

Group Type: EXPERIMENTAL

Part A: OSE-279 300mg

Intervention Type: DRUG

Human IgG4 mAb against PD-1

Part A: OSE-279 600 mg

Part A: Dose Level 3: OSE-279 600 mg

Group Type: EXPERIMENTAL

Part A: OSE-279 600mg

Intervention Type: DRUG

Human IgG4 mAb against PD-1

Part B: OSE-279 600 mg and OSE2101

Part B: OSE-279 600 mg and OSE2101

Group Type: EXPERIMENTAL

Part B: OSE-279 600 mg and OSE2101

Intervention Type: DRUG

OSE-279: OSE-279: Human IgG4 mAb against PD-1 OSE2101: Cancer vaccine

Drug: Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positif

Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positive

Group Type: EXPERIMENTAL

Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positive

Intervention Type: DRUG

OSE-279: Human IgG4 mAb against PD-1 OSE2101: Cancer vaccine

Part C: OSE-279 600 mg - HLA-A2 positif

Part C: OSE-279 600 mg - HLA-A2 positif

Group Type: EXPERIMENTAL

Part C: OSE-279 600 mg - HLA-A2 positif

Intervention Type: DRUG

OSE-279: Human IgG4 mAb against PD-1

Part C: OSE-279 600 mg - HLA-A2 negative

Part C: OSE-279 600 mg - HLA-A2 negative

Group Type: EXPERIMENTAL

Part C: OSE-279 600 mg - HLA-A2 negative

Intervention Type: DRUG

OSE-279: Human IgG4 mAb against PD-1

Interventions

Part A: OSE-279 100mg

Human IgG4 mAb against PD-1

Intervention Type: DRUG

Part A: OSE-279 300mg

Human IgG4 mAb against PD-1

Intervention Type: DRUG

Part A: OSE-279 600mg

Human IgG4 mAb against PD-1

Intervention Type: DRUG

Part B: OSE-279 600 mg and OSE2101

OSE-279: OSE-279: Human IgG4 mAb against PD-1 OSE2101: Cancer vaccine

Intervention Type: DRUG

Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positive

OSE-279: Human IgG4 mAb against PD-1 OSE2101: Cancer vaccine

Intervention Type: DRUG

Part C: OSE-279 600 mg - HLA-A2 positif

OSE-279: Human IgG4 mAb against PD-1

Intervention Type: DRUG

Part C: OSE-279 600 mg - HLA-A2 negative

OSE-279: Human IgG4 mAb against PD-1

Intervention Type: DRUG

Eligibility Criteria

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.

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)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OSE Immunotherapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Jules Bordet

Anderlecht, , Belgium

Site Status: RECRUITING

Antwerp University Hospital

Edegem, , Belgium

Site Status: NOT_YET_RECRUITING

Centre Léon Bérard

Lyon, , France

Site Status: RECRUITING

Hopital Saint Joseph

Paris, , France

Site Status: RECRUITING

Centre Eugène Marquis

Rennes, , France

Site Status: COMPLETED

Institut de Cancerologie de l'Ouest

Saint-Herblain, , France

Site Status: RECRUITING

Oncopole

Toulouse, , France

Site Status: RECRUITING

Institut Gustave Roussy

Villejuif, , France

Site Status: RECRUITING

University Hospital A Coruña Biomedical Research Institute (INIBIC)

A Coruña, , Spain

Site Status: ACTIVE_NOT_RECRUITING

Hospital Regional Universitario de Málaga

Málaga, , Spain

Site Status: NOT_YET_RECRUITING

Countries

Belgium; France; Spain

Central Contacts

Sylvie Jouve, PhD

Role: CONTACT

sylvie.jouve@ose-immuno.com

+33 631 654 710

Silvia Comis, MD

Role: CONTACT

silvia.comis@ose-immuno.com

+349 347 1495656

Other Identifiers

2022-001136-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

OSE-279-C101

Identifier Type: -

Identifier Source: org_study_id