Clinical Trials /

Study of ASP8374, an Immune Checkpoint Inhibitor, in Japanese Patients With Advanced Solid Tumors

NCT03945253

Description:

The purpose of this study is to evaluate the tolerability and safety profile and to characterize the pharmacokinetic profile of ASP8374 in Japanese patients with locally advanced (unresectable) or metastatic solid tumors. This study also evaluates the anti-tumor effect of ASP8374.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of ASP8374, an Immune Checkpoint Inhibitor, in Japanese Patients With Advanced Solid Tumors
  • Official Title: A Phase 1, Open Label Study of ASP8374, an Immune Checkpoint Inhibitor, in Japanese Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: 8374-CL-0102
  • NCT ID: NCT03945253

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
ASP8374ASP8374-dose A

Purpose

The purpose of this study is to evaluate the tolerability and safety profile and to characterize the pharmacokinetic profile of ASP8374 in Japanese patients with locally advanced (unresectable) or metastatic solid tumors. This study also evaluates the anti-tumor effect of ASP8374.

Detailed Description

      This study consists of two arms (Arm A: ASP8374 dose A; and Arm B: ASP8374 dose B). Arm B
      would only be opened if Arm A is deemed tolerable.

      The study consists of 2 periods: Screening (up to 28 days) and treatment period. The Dose
      Limiting Toxicities (DLT) observation period is set at the beginning of the treatment period.
      A subject can continue to participate in the study after the end of the DLT observation
      period until discontinuation criteria are met. After discontinuation of study drug treatment,
      all subjects will complete an end of treatment visit and safety follow-up visits.
    

Trial Arms

NameTypeDescriptionInterventions
ASP8374-dose AExperimentalParticipants will receive dose A of ASP8374 solution intravenously on day 1 of every 3-week cycle.
  • ASP8374
ASP8374-dose BExperimentalParticipants will receive dose B of ASP8374 solution intravenously on day 1 of every 3-week cycle.
  • ASP8374

Eligibility Criteria

        Inclusion Criteria:

          -  Subject has locally-advanced (unresectable) or metastatic solid tumor malignancy (no
             limit to the number of prior treatment regimens) that is confirmed by available
             pathology records or current biopsy and has received all standard therapies (unless
             the therapy is contraindicated or intolerable) felt to provide clinical benefit for
             his/her specific tumor type.

          -  Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

          -  Subject's last dose of prior antineoplastic therapy, including any immunotherapy, was
             at least 21 days prior to initiation of study drug administration. A subject with
             epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)
             mutation-positive non-small cell lung cancer (NSCLC) is allowed to remain on EGFR
             tyrosine kinase inhibitor (TKI) or ALK inhibitor therapy until 4 days prior to
             initiation of study drug administration.

          -  Subject has completed any radiotherapy (including stereotactic radiosurgery) at least
             2 weeks prior to initiation of study drug administration.

          -  Subject's adverse events (excluding alopecia) from prior therapy have improved to
             grade 1 or baseline within 14 days prior to initiation of study drug administration.

          -  Subject with metastatic castration resistant prostate cancer (mCRPC) (positive bone
             scan and/or soft tissue disease documented by computed tomography (CT)/ magnetic
             resonance imaging (MRI)) meets both of the following:

               -  Subject has serum testosterone ≤ 50 ng/dL at screening.

               -  Subject has had an orchiectomy or plans to continue androgen deprivation therapy
                  (ADT) for the duration of study treatment.

          -  Subject has adequate organ function prior to initiation of study drug administration
             per specified laboratory values criteria within 7 days prior to initiation of study
             drug administration. If a subject has received a recent blood transfusion, the
             laboratory tests must be obtained ≥ 4 weeks after any blood transfusion.

          -  A female subject is eligible to participate if she is not pregnant and at least 1 of
             the following conditions applies:

               -  Not a woman of childbearing potential (WOCBP) OR

               -  WOCBP who agrees to follow the contraceptive guidance throughout the treatment
                  period and for at least 6 months after the final study drug administration.

          -  Female subject must agree not to breastfeed starting at screening and throughout the
             treatment period, and for 6 months after the final study drug administration.

          -  Female subject must not donate ova starting at screening and throughout the treatment
             period, and for 6 months after the final study drug administration.

          -  Male subject with female partner(s) of childbearing potential (including breastfeeding
             partner(s)) must agree to use contraception during the treatment period and for at
             least 6 months after the final study drug administration.

          -  Male subject must not donate sperm starting at screening and throughout the treatment
             period, and for 6 months after the final study drug administration.

          -  Male subject with a pregnant partner(s) must agree to remain abstinent or use a condom
             for the duration of the pregnancy throughout the treatment period and for 6 months
             after the final study drug administration.

          -  Subject agrees not to participate in another interventional study while receiving
             study drug in present study (subjects who are currently in the follow-up period of an
             interventional clinical study are allowed).

        Exclusion Criteria:

          -  Subject weighs < 45 kg at screening.

          -  Subject has received investigational therapy within 21 days prior to initiation of
             study drug administration. (A subject with EGFR activating mutations or a subject with
             an ALK mutation is allowed to remain on an investigational EGFR TKI or ALK inhibitor
             until 4 days prior to initiation of study drug administration.)

          -  Subject requires or has received systemic steroid therapy or any other
             immunosuppressive therapy within 14 days prior to initiation of study drug
             administration. Subjects using a physiologic replacement dose of hydrocortisone or its
             equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of
             prednisone) are allowed.

          -  Subject has symptomatic central nervous system (CNS) metastases or subject has
             evidence of unstable CNS metastases even if asymptomatic (e.g., progression on scans).
             Subjects with previously treated CNS metastases are eligible, if they are clinically
             stable and have no evidence of CNS progression by imaging for at least 4 weeks prior
             to initiation of study drug administration and are not requiring immunosuppressive
             doses of systemic steroids (> 30 mg per day of hydrocortisone or > 10 mg per day of
             prednisone or equivalent) for longer than 2 weeks.

          -  Subject has an active autoimmune disease. Subjects with type 1 diabetes mellitus,
             endocrinopathies stably maintained on appropriate replacement therapy, or skin
             disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment
             are allowed.

          -  Subject was discontinued from prior immunomodulatory therapy due to a grade ≥ 3
             toxicity that was mechanistically related (e.g., immune related) to the agent.

          -  Subject has known history of serious hypersensitivity reaction to a known ingredient
             of ASP8374 or severe hypersensitivity reaction to treatment with another monoclonal
             antibody.

          -  Subject has a known history of Human Immunodeficiency Virus.

          -  Subject is positive for Hepatitis B virus (HBV) antibodies and surface antigen
             (including acute HBV or chronic HBV) or Hepatitis C virus ([HCV] ribonucleic acid
             [RNA]). HVC RNA testing is not required in subjects with negative Hepatitis C antibody
             testing. HBV antibodies are not required in subjects with negative Hepatitis B surface
             antigen (HBsAg).

          -  Subject has received a live vaccine against infectious diseases within 28 days prior
             to initiation of study drug administration.

          -  Subject has a history of drug-induced pneumonitis (interstitial lung disease) or
             currently has pneumonitis.

          -  Subject has an infection requiring systemic therapy within 14 days prior to initiation
             of study drug administration.

          -  Subject has received a prior allogeneic bone marrow or solid organ transplant.

          -  Subject is expected to require another form of antineoplastic therapy while on study
             treatment.

          -  Subject has had a myocardial infarction or unstable angina within 6 months prior to
             initiation of study drug administration or currently has an uncontrolled illness
             including, but not limited to symptomatic congestive heart failure, clinically
             significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, or
             psychiatric illness/social situations that would limit compliance with study
             requirements.

          -  Subject has any condition which makes the subject unsuitable for study participation.

          -  Subject has had a major surgical procedure and has not completely recovered within 28
             days prior to initiation of drug administration.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and tolerability assessed by Dose Limiting Toxicity (DLT)
Time Frame:Up to 21 days
Safety Issue:
Description:DLT is graded using National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE] Version 4.03. The DLT observation period may be increased if deemed appropriate by the Tolerability Evaluation Meeting.

Secondary Outcome Measures

Measure:Percent change in tumor size from baseline
Time Frame:Up to end of treatment period (a maximum of 105 weeks)
Safety Issue:
Description:Tumor size is defined as the sum of the diameters of all target lesions per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percent change from baseline in tumor size will be calculated for subjects with target lesions at baseline.
Measure:Best overall response (BOR) per RECIST 1.1 and 'immune' Response Evaluation Criteria in Solid Tumors (iRECIST)
Time Frame:Up to end of treatment period (a maximum of 105 weeks)
Safety Issue:
Description:BOR is defined as the best response recorded from the start of the study treatment until the end of treatment.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Astellas Pharma Inc

Trial Keywords

  • Pharmacokinetics
  • Tumors
  • Oncology
  • Safety and tolerability
  • Locally advanced or metastatic solid tumor
  • ASP8374

Last Updated

July 9, 2020