Clinical Trials /

Addition of SNS-301 to Ongoing Checkpoint Inhibitor Treatment in Metastatic/Recurrent SCCHN

NCT04034225

Description:

To evaluate safety, immunogenicity and anti-tumor responses of intradermally delivered SNS-301 added to ongoing checkpoint inhibitor therapy in ASPH+ locally advanced unresectable or metastatic/recurrent squamous cell carcinoma of the head and neck (SCCHN) patients.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Addition of SNS-301 to Ongoing Checkpoint Inhibitor Treatment in Metastatic/Recurrent SCCHN
  • Official Title: An Open-Label, Multi-Center Trial of SNS-301 Added to Pembrolizumab in Patients With ASPH+ Locally Advanced Unresectable or Metastatic/Recurrent Squamous Cell Carcinoma of the Head and Neck

Clinical Trial IDs

  • ORG STUDY ID: SNS-301-2-2
  • NCT ID: NCT04034225

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DrugSynonymsArms
SNS-301SNS-301 added to pembrolizumab
PembrolizumabKeytrudaSNS-301 added to pembrolizumab

Purpose

To evaluate safety, immunogenicity and anti-tumor responses of intradermally delivered SNS-301 added to ongoing checkpoint inhibitor therapy in ASPH+ locally advanced unresectable or metastatic/recurrent squamous cell carcinoma of the head and neck (SCCHN) patients.

Detailed Description

      This is a Phase 1/2, open-label, multi-center trial to evaluate the safety, immunogenicity
      and preliminary clinical efficacy of SNS-301 delivered intradermally in addition to
      pembrolizumab in patients with ASPH+ locally advanced unresectable or metastatic/recurrent
      SCCHN. The trial population consists of patients with ASPH+ locally advanced unresectable or
      metastatic/recurrent SCCHN who are currently receiving pembrolizumab or nivolumab therapy.
      Patients must have a best response of stable disease (SD) or first evidence of unconfirmed
      progressive disease (PD) after a minimum of 12 weeks of pembrolizumab or nivolumab therapy.
      Prior chemotherapy is allowed but not required. Patients receiving nivolumab will be switched
      over to pembrolizumab at the time of entering this study.
    

Trial Arms

NameTypeDescriptionInterventions
SNS-301 added to pembrolizumabExperimentalSNS-301 Pembrolizumab
  • SNS-301
  • Pembrolizumab

Eligibility Criteria

        Inclusion Criteria:

          1. Signed informed consent.

          2. Be 18 years of age or older.

          3. Have histologically or cytologically documented locally advanced unresectable or
             metastatic/recurrent ASPH+ SCCHN and currently receiving pembrolizumab or nivolumab
             for a minimum of 12 weeks with best response of stable disease (SD) or first evidence
             of progressive disease (PD) based on RECIST 1.1.

               1. Patients receiving first-line pembrolizumab monotherapy prior to this study must
                  be PD-L1 positive.

               2. Patients on nivolumab therapy must be willing to switch over to pembrolizumab
                  therapy.

          4. Have demonstrated intra-tumoral ASPH expression by IHC.

          5. Have measurable disease by RECIST 1.1.

          6. Eastern Cooperative Oncology Group (ECOG) Performance Scale 0-1.

          7. Have a life expectancy of ≥ 3 months.

          8. Be willing to provide a pre-treatment tissue sample.

          9. Demonstrate adequate organ function: hematological, renal, hepatic, coagulation
             parameters.

         10. For women of childbearing potential: agreement to remain abstinent (refrain from
             heterosexual intercourse) or use two highly effective contraceptive methods during the
             treatment period and for at least 180 days after the last dose of study treatment. For
             male patients: Agree that during the period specified above, men will not father a
             child. Male patients must remain abstinent, must be surgically sterile during the
             treatment period and for at least 180 days after the last dose of study treatment.

        Exclusion Criteria:

          1. Any approved anti-cancer therapy including chemotherapy, targeted small molecule
             therapy or radiation therapy within 2 weeks prior to trial Day 0.

          2. Participated on a clinical trial of an investigational agent and/or investigational
             device within 28 days prior to Day 0.

          3. Uncontrolled tumor-related pain.

          4. Malignancies other than indications open for enrollment within 3 years prior to Day 0.

          5. History of severe allergic, anaphylactic, or other hypersensitivity reactions to
             chimeric or humanized antibodies or fusion proteins.

          6. Known hypersensitivity allergy or contraindication to biopharmaceuticals produced in
             Chinese hamster ovary cells or any component of the PD-1/PD-L1 inhibitor formulation.

          7. Active or history of autoimmune disease or immune deficiency.

          8. History or any evidence of interstitial lung disease.

          9. History of HIV. HIV antibody testing recommended per investigator's clinical
             suspicion.

         10. Active hepatitis B (hepatitis B surface antigen reactive) or active hepatitis C (HCV
             qualitative RNA detected); testing recommended per investigator's clinical suspicion.

         11. Severe infections within 4 weeks prior to enrollment.

         12. Received therapeutic oral or IV antibiotics within 2 weeks prior to Day 0.

         13. History or current evidence of any condition, therapy or laboratory abnormality that
             in the opinion of the treating investigator might confound the results of the trial.

         14. Prior allogeneic stem cell or solid organ transplant.

         15. Known previous or ongoing, active psychiatric or substance abuse disorders that would
             interfere with the requirements of the trial.

         16. Treatment with systemic immunomodulating agents (including but not limited to IFNs,
             IL-2, ipilimumab) within 6 weeks or five half-lives of the drug, whichever is shorter,
             prior to first dose.

         17. Treatment with systemic immunosuppressive medication within 2 weeks prior to
             initiation of study treatment, or anticipation of need for systemic immunosuppressive
             medication during the course of the study.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Adverse events of SNS-301 in addition to pembrolizumab
Time Frame:12 weeks
Safety Issue:
Description:Number of adverse events including adverse events of special interest as assessed by CTCAE v5.0

Secondary Outcome Measures

Measure:Antigen-specific response
Time Frame:12 weeks
Safety Issue:
Description:Measure levels at pretreatment, changes during treatment and at progression or end of study
Measure:T cell and B cell activation response
Time Frame:12 weeks
Safety Issue:
Description:Measure levels at pretreatment, changes during treatment and at progression or end of study
Measure:Myeloid derived suppressor cell analysis
Time Frame:12 weeks
Safety Issue:
Description:Measure levels at pretreatment, changes during treatment and at progression or end of study
Measure:TCR sequencing
Time Frame:12 weeks
Safety Issue:
Description:Determine TCR diversity pretreatment, changes during treatment and at progression or end of study
Measure:Immune gene transcript profiling
Time Frame:12 weeks
Safety Issue:
Description:Determine gene signature pretreatment, during treatment and at progression
Measure:Profiling of pro-inflammatory/immunosuppressive molecules
Time Frame:12 weeks
Safety Issue:
Description:Measure levels at pretreatment, changes during treatment and at progression or end of study

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sensei Biotherapeutics, Inc.

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