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

Phase 1

Recruiting

• Conditions: Solid Advanced Tumor; Lymphoma; NSCLC (Non-small Cell Lung Cancer)
• Interventions: Drug: OSE-279 100mg; Drug: OSE-279 300mg; Drug: OSE-279 500mg

• Registration Number: NCT05751798
• Lead Sponsor: OSE Immunotherapeutics

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.

Study Timeline

• Study Start: 2022-12-20
• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-02
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-12
• Last Update Posted: 2025-09-18
• Primary Completion: 2029-12
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
OSE-279 100 mg	OSE-279 100mg	Dose Level 1: OSE-279 100 mg
OSE-279 300 mg	OSE-279 300mg	Dose Level 2: OSE-279 300 mg
OSE-279 500 mg	OSE-279 500mg	Dose Level 3: OSE-279 500 mg

Primary Outcome Measures

Name	Time	Method
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: 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	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

Secondary Outcome Measures

Name	Time	Method
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: 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 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	Part A and Part B: Progression Free Survival (PFS). 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: Up to 12 weeks Part B: 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.
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 A and Part B: Overall Survival (OS). Part C: Overall Survival (OS) rate.
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: Disease Control Rate (DCR): complete response (CR), partial response (PR) and stable disease (SD) based on RECIST 1.1/RECIL and iRECIST
Part A and Part B: Time to response. Part C: Duration of Objective Response (DOR)	Time	Part A and Part B: Time to response
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: Duration of response (DR). Part C: Progression Free Survival (PFS)
Part B: Overall Survival (OS) rate.	Part B: Overall Survival (OS) rate at 12months

Trial Locations

Locations (10)

Institut Jules Bordet; 🇧🇪 Anderlecht, Belgium

Antwerp University Hospital; 🇧🇪 Edegem, Belgium

Centre Léon Bérard; 🇫🇷 Lyon, France

Hopital Saint Joseph; 🇫🇷 Paris, France

Centre Eugène Marquis; 🇫🇷 Rennes, France

Institut de Cancerologie de l'Ouest; 🇫🇷 Saint-Herblain, France

Oncopole; 🇫🇷 Toulouse, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

University Hospital A Coruña Biomedical Research Institute (INIBIC); 🇪🇸 A Coruña, Spain

Hospital Regional Universitario de Málaga; 🇪🇸 Málaga, Spain