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, Trial ID 8374-CL-0101

Study summary

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

Additional Study Details

Phase

Phase 1

Product

N/A

Product

ASP8374

Pembrolizumab

Type

Interventional

Masking

None (Open Label)

Enrollment number

169

Show Additional Study Details

Study documents

Scientific Results Summary

Available Language(s): English

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Plain Language Summary

Available Language(s): English

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Locations

Withdrawn

Site IT39013

Pisa, Italy

Completed

Honor Health Research Institute

Scottsdale, AZ, United States, 85258

Completed

Site IT39009

Milano, Italy

Completed

Site GB44006

London, United Kingdom

Completed

Site CA15004

Edmonton, Alberta, Canada, T6G 1Z2

Completed

Mary Crowley Research Center

Dallas, TX, United States, 75251

Completed

Fox Chase Cancer Center

Philadelphia, PA, United States, 19111

Completed

Site KR82001

Seoul, Republic of Korea, 03080

Completed

University of Pittsburgh Cancer Institute

Pittsburgh, PA, United States, 15232

Withdrawn

Site GB44001

Leeds, United Kingdom

Completed

Site TW88603

Taipei City, Taiwan, Province of China

Completed

Site IT39010

Modena, Italy

Completed

Site TW88602

Taichung, Taiwan, Province of China, 00404

Withdrawn

Site IT39007

Siena, Italy

Completed

Site CA15002

Montreal, Quebec, Canada, H3T 1E2

Completed

Site IT39008

Milano, Italy

Completed

Huntsman Cancer Institute

Salt Lake City, UT, United States, 84112

Completed

Site PT35106

Porto, Portugal

Completed

Site ES34009

Barcelona, Spain

Completed

Henry Ford Health System

Detroit, MI, United States, 48202

Completed

Site ES34001

Madrid, Spain

Completed

University of California, San Francisco

San Francisco, CA, United States, 94115

Completed

Site GB44004

Newcastle upon Tyne, United Kingdom

Withdrawn

Site IT39012

Meldola, Italy

Completed

Site GB44005

Sutton Surry, United Kingdom

Withdrawn

Icahn School of Medicine at Mount Sinai

New York, NY, United States, 10029

Completed

Site IT39004

Ancona, Italy

Completed

University of Kansas Cancer Center

Fairway, KS, United States, 66205

Completed

Virginia Cancer Specialists

Fairfax, VA, United States, 22031

Completed

Site GB44003

London, United Kingdom

Completed

Mount Sinai Comprehensive Cancer Center

Miami Beach, FL, United States, 33140

Completed

Site CA15001

Toronto, ON, Canada, M5G 2M9

Completed

Site KR82005

Seongnam-Si, Gyeonggi-do, Republic of Korea, 013620

Completed

SIte KR82002

Seoul, Republic of Korea, 120-752

Completed

Site KR82004

Goyang-si, Gyeonggi-do, Republic of Korea, 410-769

Completed

Site ES34006

Madrid, Spain

Completed

Cedars-Sinai Medical Center

Los Angeles, CA, United States, 90048

Completed

Medical College of Wisconsin

Milwaukee, WI, United States, 53226-3522

Completed

University Hospital of Cleveland

Cleveland, Ohio, United States, 44106

Completed

Site IT39011

Negrar, Italy

Completed

Site ES34002

Barcelona, Spain

Completed

Columbia University Medical Center

New York, NY, United States, 10032

Completed

Site KR82006

Seoul, Republic of Korea

Completed

Site ES34010

Barcelona, Spain

Completed

Site JP81001

Chuo-ku, Japan

Completed

Site ES34013

Madrid, Spain

Completed

University of Iowa Hospitals and Clinics

Iowa City, IA, United States, 52242

Withdrawn

University of Arizona

Tucson, Arizona, United States, 85719

Completed

University of California, Davis

Sacramento, CA, United States, 95817

Completed

Site ES34003

Barcelona, Spain

Completed

Site ES34014

Valencia, Spain

Completed

Site IT39003

Milano, Italy

Completed

Site PT35101

Lisboa, Portugal

Completed

Sarah Cannon Research Institute

Nashville, TN, United States, 37203

Completed

Karmanos Cancer Institute

Detroit, MI, United States, 48201

Completed

Site IT39005

Monza, Italy

Completed

Site CA15003

Toronto, ON, Canada, M4N 3M5

Completed

University of California Los Angeles

Los Angeles, CA, United States, 90095

Withdrawn

University of North Carolina

Chapel Hill, NC, United States, 27599

Completed

Site TW88601

Tainan, Taiwan, Province of China

Completed

Site IT39002

Milano, Italy

Trial info

Follow Trial

Age

18+ years

Condition

Advanced/Metastatic Cancer

Sex

Female & Male

Trial Dates

Sep 2017 - May 2022

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Additional Study Details

Inclusion 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 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
- For an expansion cohort opened due to achieving predicted efficacious exposure, subject has squamous cell carcinoma of the head and neck (SCCHN); or
- For tumor specific expansion cohorts of ASP8374 with pembrolizumab, subject has the applicable tumor type (e.g., non-small cell lung cancer (NSCLC), bladder cancer, gastric cancer, metastatic castration resistant prostate cancer (MCRPC) or colorectal cancer (CRC)).
Subject has at least 1 measureable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Subjects with mCRPC who do not have measurable lesions must have at least one of the following:
- Progression with 2 or more new bone lesions; or
- Prostate-specific antigen (PSA) progression (defined as a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination) within 6 weeks prior to study drug administration and a PSA value at the screening visit ≥ 2 ng/mL.
Subject consents to provide an available tumor specimen in a tissue block or unstained serial slides obtained within 56 days prior to first dose of study treatment, or subject is an appropriate candidate for tumor biopsy and is amenable to undergoing a tumor biopsy (core needle biopsy or excision) during the screening period.This does not apply to subjects with mCRPC without measurable disease.
Subject in any expansion cohort, is an appropriate candidate for tumor biopsy and consents to undergoing a tumor biopsy (core needle biopsy or excision) during the treatment period as indicated in the Schedule of Assessments.

Exclusion:

Subject weighs < 45 kg at screening.
Subject has received investigational therapy (other than an investigational epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) in a subject with EGFR activating mutations or ALK inhibitor in a subject with an ALK mutation) within 21 days or 5 half-lives, whichever is shorter, prior to start of study drug.
Subject requires or has received systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to study drug administration. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone 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 subject is clinically stable and have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study treatment 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 pembrolizumab or severe hypersensitivity reaction to treatment with another monoclonal antibody.
Subject has a known history of Human Immunodeficiency Virus.
Subject with positive for Hepatitis B virus (HBV) antibodies and surface antigen (including acute HBV or chronic HBV) or Hepatitis C ([HCV]; ribonucleic acid [RNA] detected by qualitative assay). Hepatitis C RNA testing is not required in subjects with negative Hepatitis C antibody testing.
Subject has received a live vaccine against infectious diseases within 28 days prior to initiation of study treatment.
Subject has a history of drug-induced pneumonitis (interstitial lung disease), a history of (non-infectious) pneumonitis that required steroids, radiation pneumonitis or currently has pneumonitis.
Subject has an infection requiring systemic therapy within 14 days prior to study drug treatment.
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 the start of study treatment 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.
Any condition that makes the subject unsuitable for study participation.
Subject has had a major surgical procedure and has not completely recovered within 28 days prior to the start of study treatment.

Frequently Asked Questions

Are clinical trials only for people with advanced cancer?

While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

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Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

Should I be worried about getting a placebo?

In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

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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

Study summary

Additional Study Details

Study documents

Get more information

Locations

Frequently Asked Questions

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