A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

The primary purpose of this study is to evaluate the tolerability and safety profile of ASP8374 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumor malignancies. Also primary purpose is to characterize the pharmacokinetic profile of ASP8374 when administered as a single agent and in combination with pembrolizumab. Last primary purpose of this study is to determine the recommended Phase 2 dose (RP2D) of ASP8374 when administered as a single agent and in combination with pembrolizumab. The secondary purpose of this study is to evaluate the anti-tumor effect (objective response rate \[ORR\], duration of response \[DOR\], persistence of response after discontinuation, and disease control rate \[DCR\]) of ASP8374 when administered as a single agent and in combination with pembrolizumab. NTP: Neutropenia NHAE:Non-haematological AE GBS: Guillain-Barré syndrome"" IRR: Infusion-related reaction AST: Aspartate aminotransferase ALT: Alanine aminotransferase MS/MG: Myasthenia Syndrome/Myasthenia Gravis TRT: Treatment-related Toxicity TCP: Thrombocytopenia

Key facts

Study ID: NCT03260322
Run by: Astellas Pharma Global Development, Inc.
People needed: 169
Starts: 2017-09-08
Expected to finish: 2022-05-10
Last updated by the study team: 2025-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 as well as:
Subject in the escalation cohort has received all standard therapies (unless the therapy is contraindicated or intolerable) felt to provide clinical benefit for the subject's specific tumor type. OR
Subject in an expansion cohort has received at least one standard therapy for the subject's specific tumor type.
For Korea, Italy and Portugal only: 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 the subject's specific tumor type.
Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
Subject's last dose of prior antineoplastic therapy, including any immunotherapy, was 21 days or 5 half-lives, whichever is shorter, prior to initiation of study drug administration. A subject with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation-positive NSCLC is allowed to remain on EGFR tyrosine kinase inhibitor (TKI) therapy or ALK inhibitor until 4 days prior to the start of study drug administration.
For Korea only: Subject's last dose of prior antineoplastic therapy, including any immunotherapy, was at least 21 days or 5 half-lives, whichever is shorter, prior to initiation of study drug administration. For drugs with a half-life greater than or equal to 21 days, the investigator should consider if this washout is sufficient. A subject with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) is allowed to remain on EGFR tyrosine kinase inhibitor (TKI) therapy until 7 days prior to the start of study drug administration.
Subject has completed any radiotherapy (including stereotactic radiosurgery) at least 2 weeks prior to study drug administration.
Subject's adverse events (excluding alopecia) from prior therapy have improved to grade 1 or baseline within 14 days prior to start of study treatment.
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 start of study treatment as indicated by the following laboratory values. If a subject has received a recent blood transfusion, the laboratory tests must be obtained ≥ 4 weeks after any blood transfusion.
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)
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 study treatment, and for 6 months after the final study drug administration.
Female subject must not donate ova starting at screening and throughout the study treatment, and for 6 months after the final study drug administration.
A male subject with female partner(s) of childbearing potential must agree to use contraception as detailed 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 study treatment, and for 6 months after the final study drug administration.
Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study treatment and for 6 months after the final study drug administration.
Subject agrees not to participate in another interventional study while receiving study drug (subjects who are currently in the follow-up period of an interventional clinical trial are allowed).
Additional Inclusion Criteria for Subjects in the Expansion Cohorts:
Subject meets one of the following:
Subject has the tumor type for which a confirmed response was observed in a monotherapy or combination therapy dose escalation cohort; or

Where it is running

Cedars-Sinai Medical Center — Los Angeles, California, United States
University of California Los Angeles — Los Angeles, California, United States
University of California, Davis — Sacramento, California, United States
University of California, San Francisco — San Francisco, California, United States
Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
University of Kansas Cancer Center — Fairway, Kansas, United States
Karmanos Cancer Institute — Detroit, Michigan, United States
Henry Ford Health System — Detroit, Michigan, United States
Columbia University Medical Center — New York, New York, United States
University Hospital of Cleveland — Cleveland, Ohio, United States
Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute — Nashville, Tennessee, United States
Mary Crowley Research Center — Dallas, Texas, United States
Huntsman Cancer Institute — Salt Lake City, Utah, United States
Virginia Cancer Specialists — Fairfax, Virginia, United States
Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Site CA15004 — Edmonton, Alberta, Canada
Site CA15003 — Toronto, Ontario, Canada
Site CA15001 — Toronto, Ontario, Canada
Site CA15002 — Montreal, Quebec, Canada
Site IT39004 — Ancona, Italy
Site IT39002 — Milan, Italy
Honor Health Research Institute — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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