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

ConditionsSolid Advanced TumorLymphomaNSCLC (Non-small Cell Lung Cancer)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOSE Immunotherapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • Part A: OSE-279 100mg

    Drug

    Human IgG4 mAb against PD-1

  • Part A: OSE-279 300mg

    Drug

    Human IgG4 mAb against PD-1

  • Part A: OSE-279 600mg

    Drug

    Human IgG4 mAb against PD-1

  • Part B: OSE-279 600 mg and OSE2101

    Drug

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

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

    Drug

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

  • 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 negative

    Drug

    OSE-279: Human IgG4 mAb against PD-1

Treatment groups

41 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Part A: OSE-279 100 mgExperimental treatment 1 intervention
Group B: Part A: OSE-279 300 mgExperimental treatment 1 intervention
Group C: Part A: OSE-279 600 mgExperimental treatment 1 intervention
Group D: Part B: OSE-279 600 mg and OSE2101Experimental treatment 1 intervention
Group E: Drug: Part C: OSE-279 600 mg and OSE2101 - HLA-A2 positifExperimental treatment 1 intervention
Group F: Part C: OSE-279 600 mg - HLA-A2 positifExperimental treatment 1 intervention
Group G: Part C: OSE-279 600 mg - HLA-A2 negativeExperimental treatment 1 intervention

Trial outcomes

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

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

Secondary outcomes

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

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
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

Time frame
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

Time frame
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)

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OSE Immunotherapeutics

Lead sponsor

Source ClinicalTrials.gov
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