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Solid Advanced TumorPhase 1/2NCT05751798

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

A Phase 1/2 study testing Part A: OSE-279 100mg, Part A: OSE-279 300mg and Part A: OSE-279 600mg in people with Solid Advanced Tumor and Lymphoma, run by OSE Immunotherapeutics at 11 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Part A: OSE-279 100mg, Part A: OSE-279 300mg and Part A: OSE-279 600mg
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
11 sitesin 3 countries
Study dates
20 Dec 2022to Dec 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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:
  10. Bone marrow: neutrophils ≥ 1.5 x 109/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 x 109/L
  11. Renal function: serum creatinine ≤ 1.5 ULN or CKDEPI creatinine clearance ≥ 30 mL/min
  12. 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

Trial locations and contacts

11 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Sylvie Jouve, PhD contact

+33 631 654 710

sylvie.jouve@ose-immuno.com

Silvia Comis, MD contact

+349 347 1495656

silvia.comis@ose-immuno.com

11 sites in 3 countries

France6 sites, 5 recruiting

  • Centre Léon Bérard

    Lyon, 69373

    Recruiting

  • Hopital Saint Joseph

    Paris, 75014

    Recruiting

  • Centre Eugène Marquis

    Rennes, 35000

    Completed

  • Institut de Cancerologie de l'Ouest

    Saint-Herblain, 44805

    Recruiting

  • Oncopole

    Toulouse, 31059

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    Recruiting

Other trials in France

Spain3 sites, 3 recruiting

  • University Hospital A Coruña Biomedical Research Institute (INIBIC)

    A Coruña

    Recruiting

  • Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI)

    Girona, 17007

    Recruiting

  • Hospital Regional Universitario de Málaga

    Málaga, 2901

    Recruiting

Other trials in Spain

Belgium2 sites, 2 recruiting

  • Institut Jules Bordet

    Anderlecht, 1070

    Recruiting

  • Antwerp University Hospital

    Edegem, 11013

    Recruiting

Other trials in Belgium

About this study

Official title: 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.

Read the 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.
Being tested
Part A: OSE-279 100mg, Part A: OSE-279 300mg, Part A: OSE-279 600mg, Part B: OSE-279 600 mg and OSE2101, Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positive
Keywords
Solid advanced tumor, Lymphoma, Rare tumor, PD-L1 positive tumor, PD-1 blocking monoclonal antibody, NSCLC (non-small cell lung cancer), Cancer vaccine, Immune check point inhibitor, TEDOPI, OSE2101, OSE-2101, OSE 2101, OSE-279, OSE 279, HLA-A2
Medical subject headings
Lymphoma, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Part A: OSE-279 100mgDrug

    Human IgG4 mAb against PD-1

  • Part A: OSE-279 300mgDrug

    Human IgG4 mAb against PD-1

  • Part A: OSE-279 600mgDrug

    Human IgG4 mAb against PD-1

  • Part B: OSE-279 600 mg and OSE2101Drug

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

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

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

  • Part C: OSE-279 600 mg - HLA-A2 positifDrug

    OSE-279: Human IgG4 mAb against PD-1

  • Part C: OSE-279 600 mg - HLA-A2 negativeDrug

    OSE-279: Human IgG4 mAb against PD-1

Study groups in NCT05751798
Study groupRoleWhat they receive
Part A: OSE-279 100 mgExperimentalPart A: Dose Level 1: OSE-279 100 mg
Receives: Drug: Part A: OSE-279 100mg
Part A: OSE-279 300 mgExperimentalPart A: Dose Level 2: OSE-279 300 mg
Receives: Drug: Part A: OSE-279 300mg
Part A: OSE-279 600 mgExperimentalPart A: Dose Level 3: OSE-279 600 mg
Receives: Drug: Part A: OSE-279 600mg
Part B: OSE-279 600 mg and OSE2101ExperimentalPart B: OSE-279 600 mg and OSE2101
Receives: Drug: Part B: OSE-279 600 mg and OSE2101
Drug: Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positifExperimentalPart C: OSE-279 600 mg and OSE2101 - HLA-A2 positive
Receives: Drug: Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positive
Part C: OSE-279 600 mg - HLA-A2 positifExperimentalPart C: OSE-279 600 mg - HLA-A2 positif
Receives: Drug: Part C: OSE-279 600 mg - HLA-A2 positif
Part C: OSE-279 600 mg - HLA-A2 negativeExperimentalPart C: OSE-279 600 mg - HLA-A2 negative
Receives: Drug: Part C: OSE-279 600 mg - HLA-A2 negative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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 outcomes (8)

  1. 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

    Measured: 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

  2. 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

    Measured: Part A: Through study completion, an average of 1 year

  3. Part A and Part B: Time to response. Part C: Duration of Objective Response (DOR)

    Part A and Part B: Time to response

    Measured: Time

  4. 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)

    Measured: 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)

  5. 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

    Measured: 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

  6. 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.

    Measured: Part A: Up to 12 weeks Part B: at 12 weeks and 24 weeks

  7. 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.

    Measured: Part A and Part C: From start of treatment to Death (up to 2 years). Part C: Overall Survival (OS) rate at 12 months.

  8. Part B: Overall Survival (OS) rate.

    Measured: Part B: Overall Survival (OS) rate at 12months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2023
  2. Study start20 Dec 2022
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Part A: 3 dose levels: Dose selection (completed) Part B: 1 dose level: OSE-279 + OSE2101 Note: Part C is conditional upon Part B. Part C: 2 dose levels s(HLA-A2 positive). 2:1 ratio: OSE-279 + OSE2101 or OSE-279. Part C: 1 dose level: OSE-279 (HLA-A2 negative)
Masking
None (open label)
Enrolment
41 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05751798
Sponsor's protocol ID
OSE-279-C101
Other IDs
2022-001136-28
Status last verified
Jun 2026
First submitted
30 Jan 2023
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 42034003

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Part A: OSE-279 100mg, Part A: OSE-279 300mg and Part A: OSE-279 600mg in people with Solid Advanced Tumor and Lymphoma, run by OSE Immunotherapeutics at 11 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France, Spain, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sylvie Jouve, PhD (+33 631 654 710, sylvie.jouve@ose-immuno.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05751798, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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