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
• 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

Not available

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: 2024-06
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-14
• Primary Completion: 2024-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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
Occurrence of dose limiting toxicity (DLT)	DLT observation period is defined as the first 21 days after receiving the 1st injection of OSE-279 (Cycle 1)	Occurrence of dose limiting toxicity (DLT)

Secondary Outcome Measures

Name	Time	Method
Duration of response (DR)	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)	Duration of response (DR)
Progression Free Survival (PFS)	From start of treatment until date of progression based on RECIST 1.1/RECIL and iRECIST or date of death (up to 1 year)	Progression Free Survival (PFS)
DCR at 12 weeks (CR+PR+SD)	Up to 12 weeks	DCR at 12 weeks (CR+PR+SD)
Overall Survival (OS)	From start of treatment to Death (up to 2 years)	Overall Survival (OS)
Objective Response Rate (ORR)	Through study completion, an average of 1 year	Objective Response Rate (ORR): complete response (CR) and partial response (PR), based on RECIST 1.1/RECIL and iRECIST
Time to response	From start of treatment until date of first occurence of response (CR or PR based on RECIST 1.1/RECIL and iRECIST), an average of 1 year	Time to response
Disease Control Rate (DCR: CR, PR and SD)	Through study completion, an average of 1 year	Disease Control Rate (DCR): complete response (CR), partial response (PR) and stable disease (SD) based on RECIST 1.1/RECIL and iRECIST

Trial Locations

Locations (6)

Centre Léon Bérard; 🇫🇷 Lyon, France

Institut Jules Bordet; 🇧🇪 Anderlecht, Belgium

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

Centre Eugène Marquis; 🇫🇷 Rennes, France

Oncopole; 🇫🇷 Toulouse, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France