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

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma; NSCLC (Non-small Cell Lung Cancer); Solid Advanced Tumor
• Intervention / Treatment: Drug: Part A: OSE-279 100mg; Drug: Part A: OSE-279 300mg; Drug: Part A: OSE-279 600mg; Drug: Part B: OSE-279 600 mg and OSE2101; Drug: Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positive; Drug: Part C: OSE-279 600 mg - HLA-A2 positif; Drug: Part C: OSE-279 600 mg - HLA-A2 negative

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.

• Study Type: Interventional
• Enrollment (Estimated): 41
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Sylvie Jouve, PhD; Phone Number: +33 631 654 710; Email: sylvie.jouve@ose-immuno.com
• Study Contact Backup: Name: Silvia Comis, MD; Phone Number: +349 347 1495656; Email: silvia.comis@ose-immuno.com

Study Locations

• Belgium
  • Anderlecht, Belgium, 1070
    • Recruiting
    • Institut Jules Bordet
  • Edegem, Belgium, 11013
    • Recruiting
    • Antwerp University Hospital
• France
  • Lyon, France, 69373
    • Recruiting
    • Centre Léon Bérard
  • Paris, France, 75014
    • Recruiting
    • Hopital Saint Joseph
  • Rennes, France, 35000
    • Completed
    • Centre Eugene Marquis
  • Saint-Herblain, France, 44805
    • Recruiting
    • Institut de cancerologie de l'ouest
  • Toulouse, France, 31059
    • Recruiting
    • Oncopole
  • Villejuif, France, 94805
    • Recruiting
    • Institut Gustave Roussy
• Spain
  • A Coruña, Spain
    • Recruiting
    • University Hospital A Coruña Biomedical Research Institute (INIBIC)
  • Girona, Spain, 17007
    • Recruiting
    • Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI)
  • Málaga, Spain, 2901
    • Recruiting
    • Hospital Regional Universitario de Malaga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: OSE-279 100 mg; Part A: Dose Level 1: OSE-279 100 mg	Drug: Part A: OSE-279 100mg; Human IgG4 mAb against PD-1
Experimental: Part A: OSE-279 300 mg; Part A: Dose Level 2: OSE-279 300 mg	Drug: Part A: OSE-279 300mg; Human IgG4 mAb against PD-1
Experimental: Part A: OSE-279 600 mg; Part A: Dose Level 3: OSE-279 600 mg	Drug: Part A: OSE-279 600mg; Human IgG4 mAb against PD-1
Experimental: Part B: OSE-279 600 mg and OSE2101	Drug: Part B: OSE-279 600 mg and OSE2101; OSE-279: OSE-279: Human IgG4 mAb against PD-1 OSE2101: Cancer vaccine
Experimental: Drug: Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positif; Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positive	Drug: Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positive; OSE-279: Human IgG4 mAb against PD-1 OSE2101: Cancer vaccine
Experimental: Part C: OSE-279 600 mg - HLA-A2 positif	Drug: Part C: OSE-279 600 mg - HLA-A2 positif; OSE-279: Human IgG4 mAb against PD-1
Experimental: Part C: OSE-279 600 mg - HLA-A2 negative	Drug: Part C: OSE-279 600 mg - HLA-A2 negative; OSE-279: Human IgG4 mAb against PD-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Occurrence of dose limiting toxicity (DLT). Part B: Safety and tolerability of the combination OSE-279/OSE2101. Part C: Overall response rate (ORR) of the combination OSE-279/OSE2101	Part A: Occurrence of dose limiting toxicity (DLT) Part B: Occurrence of dose limiting toxicity (DLT) Part C: ORR: Complete Response (CR) and Partial Response (PR) rate	Part A: DLT observation period is defined as the first 21 days after receiving the 1st injection of OSE-279 (Cycle 1) Part B: DLT observation period is defined as the first 6 weeks after receiving the combinaison Part C: Best response

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Objective Response Rate (ORR). Part B: Complete Response (CR) and Partial Response (PR) rate. Part C: CR, PR and Stable Disease (SD) rate	Part A: Objective Response Rate (ORR): complete response (CR) and partial response (PR), based on RECIST 1.1/RECIL and iRECIST Part B: Objective Response Rate (ORR): complete response (CR) and partial response (PR), based on RECIST 1.1/RECIL and iRECIST Part C: CR, PR and Stable Disease (SD) rate, based on RECIST 1.1/RECIL and iRECIST	Part A: Through study completion, an average of 1 year Part B: ORR, DCR, DOR, TTR, DCR at 12 weeks and 24 weeks, PFS, OS and OS at 12 months Part C: DCR,TTR, DOR, PFS at 12 weeks and 24 weeks, OS and OS rate at 12 months
Part A and Part B: Disease Control Rate (DCR: CR, PR and SD). Part C: Time to response	Part A and Part B: Disease Control Rate (DCR): complete response (CR), partial response (PR) and stable disease (SD) based on RECIST 1.1/RECIL and iRECIST	Part A: Through study completion, an average of 1 year
Part A and Part B: Time to response. Part C: Duration of Objective Response (DOR)	Part A and Part B: Time to response	Time
Part A and Part B: Duration of response (DR). Part C: Progression Free Survival (PFS)	Part A and Part B: Duration of response (DR). Part C: Progression Free Survival (PFS)	Part A: From the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death (up to 1 year)
Part A and Part B: Progression Free Survival (PFS). Part C: DCR (CR+PR+SD) at 12 weeks and 24 weeks	Part A and Part B: Progression Free Survival (PFS). Part C: DCR at 12 weeks and 24 weeks	Part A: From start of treatment until date of progression based on RECIST 1.1/RECIL and iRECIST or date of death (up to 1 year). Part C: DCR at 12 weeks and 24 weeks
Part A: DCR at 12 weeks (CR+PR+SD). Part B: DCR at 12 weeks and 24 weeks (CR+PR+SD). Part C: Overall Survival (OS)	Part A: DCR at 12 weeks (CR+PR+SD). Part B: DCR at 12 weeks and 24 weeks (CR+PR+SD). Part C: Overall Survival.	Part A: Up to 12 weeks Part B: at 12 weeks and 24 weeks
Part A and Part B: Overall Survival (OS). Part C: Overall Survival (OS) rate.	Part A and Part B: Overall Survival (OS). Part C: Overall Survival (OS) rate.	Part A and Part C: From start of treatment to Death (up to 2 years). Part C: Overall Survival (OS) rate at 12 months.
Part B: Overall Survival (OS) rate.		Part B: Overall Survival (OS) rate at 12months

Collaborators and Investigators

• Sponsor: OSE Immunotherapeutics

Publications and helpful links

General Publications

• Robert M, Kotecki N, Gomez-Roca C, Massard C, Postel-Vinay S, Raimbourg J, Brandao M, Korakis I, Rouge TM, Comis S, Imadalou K, Chevalier C, Cordonnier L, Josse C, Teppaz G, Seite M, Durand J, Thepenier V, Mary C, Gauttier V, Derame M, Morello A, Poirier N, Cassier PA. A Phase 1 dose-escalation study to evaluate safety, pharmacokinetics, and pharmacodynamics of OSE-279, an anti-PD-1 monoclonal antibody in patients with advanced solid tumours. Eur J Cancer. 2026 Jun 3;240:116729. doi: 10.1016/j.ejca.2026.116729. Epub 2026 Apr 9.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Lymphoma; Cancer vaccine; Rare tumor; HLA-A2; TEDOPI; NSCLC (non-small cell lung cancer); Immune check point inhibitor; Solid advanced tumor; PD-L1 positive tumor; PD-1 blocking monoclonal antibody; OSE2101; OSE-2101; OSE 2101; OSE-279; OSE 279
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Immune System Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Carcinoma, Bronchogenic; Bronchial Neoplasms; Hemic and Lymphatic Diseases; Lymphoma; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: OSE-279-C101; 2022-001136-28 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No