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An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors

NCT04305795

Description:

Open-label study using ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy in patients with recurrent or metastatic head and neck and squamous cell cancer or advanced or metastatic cutaneous squamous cell carcinoma.

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

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors
  • Official Title: An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: ASP-1929-181
  • NCT ID: NCT04305795

Conditions

  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Metastatic Head-and-neck Squamous-cell Carcinoma
  • Locally Advanced Cutaneous Squamous Cell Carcinoma
  • Metastatic Cutaneous Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
200 mg PembrolizumabCohort 1 - 1L HNSCC
Cemiplimab 350mgCohort 2 - 1L cuSCC

Purpose

Open-label study using ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy in patients with recurrent or metastatic head and neck and squamous cell cancer or advanced or metastatic cutaneous squamous cell carcinoma.

Detailed Description

      Cohorts of patients with recurrent or metastatic (R/M) squamous cell cancer of the head and
      neck (HNSCC) or advanced or metastatic cutaneous squamous cell carcinoma will receive
      anti-PD1 therapy in combination with anti EGFR antibody-dye conjugate, ASP-1929, followed by
      photoimmunotherapy (PIT). HNSCC patients are required to have positive expression of
      programmed cell death ligand 1 (PD-L1) defined by Combined Positive Score (CPS) ≥1. Primary
      endpoints are safety, tolerability, and tumor response of ASP-1929 PIT treatment in
      combination with anti-PD1.
    

Trial Arms

NameTypeDescriptionInterventions
Cohort 1 - 1L HNSCCOtherRecurrent locally advanced and/or metastatic head and neck squamous cell carcinoma
  • 200 mg Pembrolizumab
Cohort 2 - 1L cuSCCOtherLocally advanced or metastatic cutaneous squamous cell carcinoma
  • Cemiplimab 350mg
Cohort 3 - 2L + cuSCCOtherLocally advanced or metastatic cutaneous squamous cell carcinoma
  • Cemiplimab 350mg

Eligibility Criteria

        Overall Inclusion Criteria:

        Provide written informed consent

        • Cancers as follows:

        Cohort 1 : Histologically or cytologically confirmed recurrent locally and/or metastatic
        head and neck squamous cell carcinoma with Combined Positive Score (CPS) ≥ 1 as determined
        by an FDA approved test

        Note: A multi-disciplinary group (including a surgeon and radiation oncologist) must agree
        that the patient is not a candidate for locoregional therapy.

        Cohort 2 : Histologically or cytologically confirmed locally advanced or metastatic
        cutaneous squamous cell carcinoma not amenable to definitive surgery or radiation.

        Cohort 3: Histologically or cytologically confirmed locally advanced or metastatic
        cutaneous squamous cell carcinoma not amendable to definitive surgery or radiation.
        Patients' disease has progressed despite at least 2 months of anti-PD1 therapy.

          -  At least one site of disease accessible to light illumination

          -  Measurable disease by modified RECIST 1.1

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  No prior systemic therapy administered in the recurrent and/or metastatic setting
             (with the exception of systemic therapy completed ≥ 6 months prior if given as part of
             multimodal treatment for locally advanced disease)

          -  Adequate organ function

          -  Female patients of childbearing potential must have a negative pregnancy test at
             screening and must be willing to use 2 methods of highly effective birth control while
             on study or be surgically sterile, or abstain from heterosexual sexual activity for
             the course of the study through 120 days after the last dose of anti-PD1 treatment.

          -  Male participants must agree to use a highly effective method of contraception
             starting with the first dose of study medication through 120 days after the last dose
             of anti-PD1 treatment.

        Exclusion Criteria:

          -  Prior therapy with an anti-PD1 or anti-PD-L1 (Cohort 1 and 2 only)

          -  Radiation therapy (or other non-systemic therapy) within 4 weeks prior to study Day 1
             or not fully recovered from adverse events due to a previously administered treatment

          -  Receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of
             prednisone equivalent) or any other form of immunosuppressive therapy within 14 days
             prior to Cycle 1 Day 1.

          -  Diagnosed and/or treated for additional malignancy within 2 years prior to study Day
             1, except for, curatively treated basal cell carcinoma of the skin, squamous cell
             carcinoma of the skin and/or curatively resected in situ cervical and/or breast
             cancers

          -  History of significant (≥ Grade 3) cetuximab infusion reactions

          -  Prior allogeneic tissue/solid organ transplant

          -  Known or active central nervous system metastases and/or carcinomatous meningitis

          -  Active autoimmune disease that has required systemic treatment in past 2 years (ie,
             with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).

          -  Evidence of interstitial lung disease or current active, noninfectious pneumonitis

          -  Active infection requiring systemic therapy

          -  Known or active bacterial, viral, and fungal infection including tuberculosis, active
             Hepatitis B (eg, HBsAg reactive), or Hepatitis C (eg, RNA [qualitative] is detected)

          -  Known history of testing positive for human immunodeficiency virus (HIV) or acquired
             immunodeficiency syndrome (AIDS)-related illness

          -  Received a live vaccine within 30 days of study Day 1. Note: seasonal influenza
             vaccines for injection are generally inactivated flu vaccines and are allowed; however
             intranasal influenza vaccines (eg, Flu-Mist®) are live attenuated vaccines, and are
             not allowed.

          -  Patients expecting to breastfeed during the study and through 120 days after the last
             dose of study treatment

          -  Major surgery or significant traumatic injury ≤ 28 days before study day 1, or
             anticipation of the need for major surgery during the course of study treatment.

          -  Currently participating or participated in a study of an investigational agent and
             received study therapy (including RM-1929 or ASP-1929 PIT studies), or used an
             investigational device within 4 weeks of study Day 1

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Characterize the safety and tolerability of ASP-1929 PIT treatment in combination with anti-PD1 therapy
Time Frame:24 months
Safety Issue:
Description:Treatment Emergent Adverse Events (TEAE) and Serious TEAE

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:24 months
Safety Issue:
Description:Assess the effect of ASP-1929 PIT treatment in combination with anti-PD1 therapy on survival
Measure:Progression-free survival (PFS)
Time Frame:24 months
Safety Issue:
Description:Assess the effect of ASP-1929 PIT treatment in combination with anti-PD1 therapy on survival
Measure:Duration of Response (DOR)
Time Frame:24 months
Safety Issue:
Description:Assess the effect of ASP-1929 PIT treatment in combination with anti-PD1 therapy on survival

Details

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

Trial Keywords

  • Rakuten Medical
  • ASP-1929
  • HNSCC
  • CUSCC
  • head and neck
  • cutaneous
  • squamous cell carcinoma
  • photoimmunotherapy
  • PIT
  • skin

Last Updated

December 23, 2020