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.
* 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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Human IgG4 mAb against PD-1
Human IgG4 mAb against PD-1
Human IgG4 mAb against PD-1
Institut Jules Bordet
Anderlecht, Belgium
RECRUITINGAntwerp University Hospital
Edegem, Belgium
NOT_YET_RECRUITINGPart 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
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
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
Time frame: 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
Time frame: 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 frame: Time
Part A and Part B: Duration of response (DR). Part C: Progression Free Survival (PFS)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
OSE-279: OSE-279: Human IgG4 mAb against PD-1 OSE2101: Cancer vaccine
OSE-279: Human IgG4 mAb against PD-1 OSE2101: Cancer vaccine
OSE-279: Human IgG4 mAb against PD-1
OSE-279: Human IgG4 mAb against PD-1
Centre Léon Bérard
Lyon, France
Hopital Saint Joseph
Paris, France
RECRUITINGCentre Eugène Marquis
Rennes, France
COMPLETEDInstitut de Cancerologie de l'Ouest
Saint-Herblain, France
RECRUITINGOncopole
Toulouse, France
RECRUITINGInstitut Gustave Roussy
Villejuif, France
RECRUITINGUniversity Hospital A Coruña Biomedical Research Institute (INIBIC)
A Coruña, Spain
RECRUITINGInstitut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI)
Girona, Spain
RECRUITING...and 1 more locations
Part A and Part B: Duration of response (DR). Part C: Progression Free Survival (PFS)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Part B: Overall Survival (OS) rate at 12months