A Study of ASP1951 in Subjects with Advanced Solid Tumors, Trial ID 1951-CL-0101

Study summary

The primary purpose of this study is to evaluate the tolerability and safety profile of ASP1951 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1951 when administered as a single agent and in combination with pembrolizumab; and determine the recommended phase 2 dose (RP2D) of ASP1951 and/or maximum tolerated dose (MTD) when administered as a single agent and in combination with pembrolizumab. This study will also evaluate the anti-tumor effect of ASP1951 when administered as a single agent and in combination with pembrolizumab.

Additional Study Details

Phase

Phase 1

Product

ASP1951

Product

ASP1951

pembrolizumab

Type

Interventional

Masking

None (Open Label)

Enrollment number

119

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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

Completed

Multicare Regional Cancer Center Tacoma

Tacoma, WA, United States, 98405

Completed

Comprehensive Cancer Nevada

Las Vegas, Nevada, United States, 89169

Completed

South Texas Accelerated Research Therapeutics, LLC

San Antonio, TX, United States, 78229

Completed

Virginia Cancer Specialists

Fairfax, VA, United States, 22031

Completed

Emory University

Atlanta, Georgia, United States, 30322

Completed

University of California

Sacramento, California, United States, 95817

Completed

Columbia University Medical Center

New York, New York, United States, 10032

Completed

University of Iowa Hospitals

Iowa City, IA, United States, 52242

Completed

Site KR82003

Seoul, Republic of Korea

Completed

Site KR82005

Daegu, Republic of Korea

Completed

Site KR82002

Chungcheongbukdo, Republic of Korea

Completed

Site KR82004

Seoul, Republic of Korea

Completed

Henry Ford Health System

Detroit, MI, United States, 48202

Completed

Site TW88603

Taichung, Taiwan, Province of China

Completed

Augusta University

Augusta, GA, United States, 30912

Completed

Rush University Medical Center

Chicago, IL, United States, 60612

Completed

Rutgers Cancer Institute

New Brunswick, New Jersey, United States, 08903

Completed

University of Florida, Davis C

Gainesville, Florida, United States, 326102

Completed

Site TW88604

Taipei, Taiwan, Province of China

Completed

Site KR82007

Seoul, Republic of Korea

Completed

Site CA15002

Montreal, Canada

Completed

Site CA15005

Montreal, Canada

Completed

Hollings Cancer Center

Charleston, South Carolina, United States, 29425

Withdrawn

Start Midwest

Grand Rapids, Michigan, United States, 49546

Completed

Northwestern University

Chicago, Illinois, United States, 60611

Completed

Icahn school of Medicine at Mount Sinai

New York, New York, United States, 10029

Completed

Duke University Medical Center

Durham, NC, United States, 27705

Withdrawn

UC Irvine Medical Center

Orange, California, United States, 92868

Completed

Site KR82001

Gyeonggi-do, Republic of Korea

Completed

Site KR82006

Seoul, Republic of Korea

Completed

Nebraska Cancer Specialists

Omaha, Nebraska, United States, 68130

Completed

Arizona Clinical Research Cent

Tuscon, AZ, United States, 85715

Completed

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112

Completed

Site CA15004

Ontario, Canada

Trial info

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Age

18+ years

Condition

Advanced/Metastatic Cancer

Sex

Female & Male

Trial Dates

Jan 2019 - Jul 2023

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Additional Study Details

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 the following:
- Subject in the escalation cohort has received all standard therapies (unless the therapy is contraindicated or intolerable) felt to provide clinical benefit the subject's specific tumor type. OR
- Subject in an expansion cohort has received at least 1 standard therapy for the subject's specific tumor type.

[Taiwan 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 in the opinion of the

treating investigator for his/her specific tumor type.

Note: Subjects in the combination expansion cohort with tumor types that pembrolizumab is not approved for can only enroll if their standard treatment is ineffective, unsuitable per investigator’s judgment or if the subject is unwilling to receive the standard therapy.

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 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) or ALK inhibitor therapy until 4 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. Subjects must have recovered from all radiation related toxicities, not require corticosteroids and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to noncentral nervous system [CNS] disease.
Subject’s AEs (excluding alopecia) from prior therapy have improved to grade 1 or baseline within 2 weeks 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 a bilateral 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. If a subject has received a recent blood transfusion, the laboratory tests must be obtained ≥ 4 weeks after any blood transfusion. Subjects can be on stable dose of erythropoietin (≥ approximately 3 months).
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 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 during the treatment period and for at least 6 months after the final study drug administration.
A male subject must not donate sperm during the treatment period and for at least 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 period 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 has at least 1 measureable lesion per RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Subjects with mC RPC who do not have measurable lesions must have at least 1 of the following:
- Progression with 2 or more new bone lesions; or
- Prostate-specific antigen (PSA) progression (defined as a minimum of 3 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 available tumor specimen in a tissue block or unstained serial slides obtained within 56 days prior to first dose of study treatment. Note: This does not apply to subjects with mCRPC who do not have measurable disease.
Subject 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. Note: This does not apply to subjects with mCRPC who do not have measurable disease.
Subject meets one of the following:
- Subject has the tumor type for which a confirmed response was observed in a monotherapy or combination therapy cohort; or
- Subject has SCCHN and a combination therapy expansion cohort is opened due to achieving the predicted efficacious exposure or
- High dose RP2D combination therapy expansion cohorts are opened and subject has NSCLC (all PD-L1 status), NSCLC PD-L1 high*, SCCHN, or cervical cancer; or
- Low dose RP2D combination therapy expansion cohorts are opened and subject has NSCLC (all PD-L1 status), SCCHN and cervical cancer.

* NSCLC with PD-L1 high expressing tumor (tumor proportion score ≥ 50%) as determined by 22C3 PD-L1 immunohistochemistry assay at a local/central laboratory during the screening period. Note: Local 22C3 PD-L1 IHC assay results available within 60 days prior study drug administration may be used for evaluating this entry criterion.

Additional Inclusion Criteria for Re-treatment:

Subject stopped initial treatment with ASP1951 or ASP1951 in combination with pembrolizumab after attaining a confirmed CR, PR or SD.
Subject experienced an investigator-determined iCPD after stopping their initial treatment with ASP1951 or ASP1951 in combination with pembrolizumab.
Subject did not receive any prohibited anti-cancer treatment since the last dose of ASP1951 or ASP1951 in combination with pembrolizumab.
Subject did not experience a toxicity that met treatment discontinuation criteria during the initial treatment with ASP1951 or ASP1951 in combination with pembrolizumab or pembrolizumab alone.

Exclusion Criteria

Subject weighs < 45 kg.
Subject has received investigational therapy (other than an investigational 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, 2 mg per day of dexamethasone, or up to 10 mg per day of prednisone) are allowed.
Subject has symptomatic 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 start of study treatment and are not requiring immunosuppressive doses of systemic steroids (> 30 mg per day of hydrocortisone, > 2 mg per day of dexamethasone, or > 10 mg per day of prednisone or equivalent) for longer

than 2 weeks.

Subject has leptomeningeal disease as a manifestation of the current malignancy.
Subject has an active autoimmune disease that has required systemic treatment in the past 2 years. Subjects with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy, and 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 (≥ grade 3) to a known ingredient of ASP1951 or pembrolizumab or severe hypersensitivity reaction to treatment with another monoclonal antibody.
Subject with positive Hepatitis B virus (HBV) antibodies and surface antigen (indicating acute HBV or chronic HBV) or Hepatitis C ([HCV]; ribonucleic acid [RNA] detected by qualitative or quantitative assay). Hepatitis C RNA testing is not required in subjects with negative Hepatitis C antibody testing. HBV antibodies are not required in subjects with negative HBV surface antigen.
Subject has received a live vaccine against infectious diseases within 4 weeks 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 2 weeks prior to 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 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.
Subject has received prior treatment with an anti-glucocorticoid-induced tumor necrosis factor receptor (GITR) antibody.
Subject has had a major surgical procedure and has not completely recovered within 28 days prior to the start of study treatment.
Subject has any condition which makes the subject unsuitable for study participation.
Subject has a known history of human immunodeficiency virus (HIV) infection. No

HIV testing is required unless mandated by local health authority.

Subject has known history of coronavirus disease 2019 (COVID-19) positive polymerase chain reaction (PCR) test within 4 weeks prior to start of study treatment.

Additional Exclusion Criterion for Subjects in Expansion Cohorts:

Subject has a prior malignancy, other than the current malignancy for which the subject is seeking treatment, active (i.e., requiring treatment of intervention) within the previous 2 years except for locally curable malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.

Additional Exclusion Criteria for Re-treatment:

Subjects who have completed 45 weeks in monotherapy or 57 weeks in combination therapy follow-up with disease control are not eligible for re-treatment.
Subject currently has an ongoing AE related to ASP1951 or ASP1951 in combination with pembrolizumab that meets the criteria for treatment interruption or discontinuation.

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 Study of ASP1951 in Subjects with Advanced Solid Tumors

Study summary

Additional Study Details

Study documents

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