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

NCT05751798 | Recruiting Phase 1 DMC

• 2 other identifiers: OSE-279-C1012022-001136-28
• Study Type: interventional
• Target: 41
• Locations: 3 countries
• Sites: 11

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (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

  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)

• 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: 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: Through study completion, an average of 1 year

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

  Time

• 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: 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

Study Arms (7)

Part A: OSE-279 100 mg

EXPERIMENTAL

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

Drug: Part A: OSE-279 100mg

Part A: OSE-279 300 mg

EXPERIMENTAL

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

Drug: Part A: OSE-279 300mg

Part A: OSE-279 600 mg

EXPERIMENTAL

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

Drug: Part A: OSE-279 600mg

Part B: OSE-279 600 mg and OSE2101

EXPERIMENTAL

Part B: OSE-279 600 mg and OSE2101

Drug: Part B: OSE-279 600 mg and OSE2101

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

Interventions

Part A: OSE-279 100mg DRUG

Human IgG4 mAb against PD-1

Part A: OSE-279 100 mg

Part A: OSE-279 300mg DRUG

Human IgG4 mAb against PD-1

Part A: OSE-279 300 mg

Part A: OSE-279 600mg DRUG

Human IgG4 mAb against PD-1

Part A: OSE-279 600 mg

Part B: OSE-279 600 mg and OSE2101 DRUG

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

Part B: OSE-279 600 mg and OSE2101

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

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 - HLA-A2 positif DRUG

OSE-279: Human IgG4 mAb against PD-1

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

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

OSE-279: Human IgG4 mAb against PD-1

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥ 18 years
• Signed and dated informed consent form (ICF) prior to any trialspecific procedures.
• ECOG performance status 0-1
• Patients must be affiliated to a social security system or an equivalent system, if applicable as per local regulations.
• 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.
• 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)
• 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.
• Patients with at least one measurable lesion according to RECIST v1.1.
• Adequate organ function:
• Bone marrow: neutrophils ≥ 1.5 x 109/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 x 109/L
• Renal function: serum creatinine ≤ 1.5 ULN or CKDEPI creatinine clearance ≥ 30 mL/min
• 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.
• 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.
• Patient previously treated with approved/investigational anti-PD-1/PD-L1
• 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

Sponsors & Collaborators

• OSE Immunotherapeutics: lead

Study Sites (11)

Institut Jules Bordet

Anderlecht, 1070, Belgium

RECRUITING

Antwerp University Hospital

Edegem, 11013, Belgium

NOT YET RECRUITING

Centre Léon Bérard

Lyon, 69373, France

RECRUITING

Hopital Saint Joseph

Paris, 75014, France

RECRUITING

Centre Eugène Marquis

Rennes, 35000, France

COMPLETED

Institut de Cancerologie de l'Ouest

Saint-Herblain, 44805, France

RECRUITING

Oncopole

Toulouse, 31059, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94805, 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, 17007, Spain

RECRUITING

Hospital Regional Universitario de Málaga

Málaga, 2901, Spain

RECRUITING

MeSH Terms

Conditions

Lymphoma; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: March 2, 2023
• Study Start: December 20, 2022
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

BE (2); FR (6); ES (3)