Clinical Trials /

Phase 1b/2, Open-label Study of 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 cutaneous squamous cell carcinoma.

Related Conditions:
  • Hypopharyngeal Squamous Cell Carcinoma
  • Laryngeal Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma
  • Skin Squamous Cell Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase 1b/2, Open-label Study of ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors
  • Official Title: Phase 1b/2, Open-label Study of 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

  • Head and Neck Squamous Cell Carcinoma
  • Cutaneous Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
Pembrolizumab 200mg Intravenous infusion for HNSCCCohort 1 - Head & Neck squamous cell carcinoma
Cemiplimab 350mg Intravenous infusion for cuSCCCohort 2 - Cutaneous squamous cell carcinoma

Purpose

An Open-label Study using ASP-1929 Photoimmunotherapy in Combination with anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors in patients with head and neck and cutaneous squamous cell carcinoma.

Detailed Description

      The study will have a Head and Neck Squamous Cell Carcinoma and Cutaneous Squamous Cell
      Carcinoma cohorts.

      Cohort 1 - Head and Neck A total of 26 patients will enroll in the study with recurrent
      locally advanced and/or metastatic head and neck squamous cell carcinoma and have a combined
      positive score (CPS) greater than or equal to 1.

      Cohort 2 - Cutaneous A total of 28 patients will enroll in the study with confirmed and
      diagnosed locally advanced and/or metastatic cutaneous squamous cell carcinoma with known
      PD-L1 expression status.
    

Trial Arms

NameTypeDescriptionInterventions
Cohort 1 - Head & Neck squamous cell carcinomaOtherRecurrent and/or metastatic head and neck squamous cell carcinoma
  • Pembrolizumab 200mg Intravenous infusion for HNSCC
Cohort 2 - Cutaneous squamous cell carcinomaOtherLocally advanced and/or metastatic cutaneous squamous cell carcinoma
  • Cemiplimab 350mg Intravenous infusion for cuSCC

Eligibility Criteria

        Overall Inclusion Criteria:

        Provide written informed consent

          -  Male or female ≥ 18 years old at the time of signing informed consent

          -  Measurable disease by modified RECIST 1.1 as assessed by Investigator. Lesions located
             in a previously irradiated area are considered measurable if progression has been
             demonstrated. See modified RECIST 1.1 criteria definition for disease progression in
             applicable subprotocols. Note: The same image acquisitions and processing parameters
             used at screening should be used throughout the study.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of
             screening

          -  Life expectancy > 3 months, based on Investigator judgement

          -  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 lab values as described below (all screening labs should be
             performed within 14 days of study Day 1):

        Hematology: Adequate bone marrow function as shown by absolute neutrophil count (ANC) ≥1.5
        x 109/L, platelets ≥100 x 109/L, hemoglobin (Hb) ≥ 9 g/dL (transfusions and growth factors
        must not be used within 2 weeks of study day 1 to meet these requirements)

        Hepatic: Alkaline phosphatase (ALP) < 2 times upper limit of normal, aspartate
        aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times the upper limit of
        normal (≤ 5x ULN for patients with liver metastases), and total serum bilirubin < 2 mg/dL
        (unless the patient has Gilbert's disease)

        Renal: Creatinine clearance (CCr) ≥30 mL/min/1.73 m2 and can be calculated based upon local
        guidance.

        Glomerular filtration rate (GFR) to be calculated per the CKD-EPI equation, expressed as a
        single equation, is:

        GFR = 141 * min(Scr/κ,1)α * max(Scr/κ, 1)-1.209 * 0.993Age * 1.018 [if female] * 1.159 [if
        black] Note: Scr is serum creatinine (mg/dL), κ is 0.7 for females and 0.9 for males, α is
        -0.329 for females and -0.411 for males, min indicates the minimum of Scr/κ or 1, and max
        indicates the maximum of Scr/κ or 1

        Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5x ULN
        unless patient is receiving anticoagulant therapy as long as PT or PTT is within
        therapeutic range of intended use of anticoagulants.

          -  Female participants 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. Patients of
             childbearing potential are those who have not been surgically sterilized or have not
             been free from menses for > 1 year

          -  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.

        Inclusion Criteria for Head & Neck:

          -  Histologically- or cytologically-confirmed diagnosis of recurrent locally advanced
             and/or metastatic head and neck squamous cell carcinoma with known PD-L1 expression
             status

          -  Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. Patients
             may not have a primary tumor site of nasopharynx (any histology)

          -  At least 1 head and neck SCC accessible to light illumination

          -  Combined Positive Score (CPS) ≥ 1 as determined by an FDA approved test

        Inclusion Criteria for Cutaneous:

          -  Histologically- or cytologically-confirmed and diagnosed locally advanced and/or
             metastatic-cuSCC with known PD-L1 expression status. LA-cuSCC is defined as tumor not
             amenable to definitive surgery or radiation due to multiple recurrences, anatomic
             complexity, or other patient contraindications for therapy.

          -  At least one cutaneous SCC tumor accessible to light illumination

        Overall Exclusion Criteria:

          -  Prior therapy with an anti-PD1 or anti-PD-L1

          -  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 7 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).
             Replacement therapy (eg, thryroxine, insulin, or physiologic corticosteroid
             replacement therapy for adrenal or pituitary insufficiency) is not considered a form
             of systemic treatment

          -  History of non-infectious pneumonitis that required steroids 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.

          -  Requiring future examinations or treatments within 4 weeks after an ASP-1929 PIT
             treatment cycle exposing the patient to significant light (eg, eye examinations,
             surgical procedures, endoscopy) that is unrelated to the ASP-1929 PIT treatment

          -  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. Note:
             If participant has had major surgery, they must have recovered adequately from the
             toxicity and/or complications before study Day 1

          -  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

          -  Any other condition which, in the Investigator's opinion, deems the patient an
             unsuitable candidate to receive ASP-1929 and/or be exposed to PIT light illumination,
             and anti-PD1 treatment.

          -  Unwilling or unable to follow protocol 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 treatment
Time Frame:24 months
Safety Issue:
Description:Treatment Emergent Adverse Events (TEAE) and Serious TEAE

Secondary Outcome Measures

Measure:Overall Survival (OS) defined as the time from first dose of study treatment until death due to any cause
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) defined as the time from first dose of study treatment until disease progression per modified RECIST 1.1 or death
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) defined as the time from first response (CR or PR) to the time of disease progression (PD) per modified RECIST 1.1
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:Not yet 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

March 11, 2020