Study of ASP0739 Alone and With Pembrolizumab in Advanced Solid Tumors With NY-ESO-1 Expression Participants

  • STATUS
    Recruiting
  • End date
    Jan 31, 2028
  • participants needed
    339
  • sponsor
    Astellas Pharma Global Development, Inc.
Updated on 10 August 2022
combination therapy
measurable disease
carcinoma
squamous cell carcinoma
pembrolizumab
ny-eso-1
intraperitoneal chemotherapy
cancer of the ovary
lung carcinoma

Summary

The purpose of this study is to evaluate the safety, and tolerability of ASP0739, when administered as a single agent and in combination with pembrolizumab.

This study will also evaluate the clinical response and other measures of anticancer activity of ASP0739 when administered as a single agent and in combination with pembrolizumab based on central and local assessment.

Description

The study is comprised of 2 phases. Phase 1 (dose escalation) includes participants with solid tumors known to express New York esophageal squamous cell carcinoma 1 (NY-ESO-1). Phase 2 (ASP0739 as single agent and in combination with pembrolizumab) includes participants with relapsed/refractory Synovial Sarcoma (SS), myxoid/round cell liposarcoma (MRCL), and ovarian cancer who have not responded to Standard of Care (SOC) or are ineligible for standard therapy. Phase 2 single agent will also include a cohort of participants with select solid tumors known to express NY-ESO-1 (melanoma, Non Small Cell Lung Cancer-adenocarcinoma [NSCLC], squamous cell and esophageal squamous cell carcinoma [ESCC]).

Details
Condition Ovarian Cancer, NSCLC, ESCC, Solid Tumors
Treatment Pembrolizumab, ASP0739
Clinical Study IdentifierNCT04939701
SponsorAstellas Pharma Global Development, Inc.
Last Modified on10 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Phase 1 Dose Escalation only
Participant has relapsed/refractory (R/R) solid tumor known to express NY-ESO-1 after completing available Standard of Care (SOC) therapy or is not a candidate for SOC therapy. NY-ESO-1 expression status is not required for participant entry
Phase 2 Single agent and Combination Therapy only
Participant has relapsed/refractory (R/R) synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCL) disease after undergoing available SOC treatment or is not a candidate for SOC therapy (must have previously received either an anthracycline or ifosfamide containing regimen or another systemic regimen, if not a candidate for either agent)
Participant has not received prior checkpoint inhibitor therapy (i.e., Programmed Cell Death Protein 1 [PD-1]/Programmed Death Ligand 1 [PD-L1] treatment naive)
SS: confirmation by the presence of a translocation between SYT on the X chromosome and SSX1, SSX2, or SSX4 on chromosome 18 (may be presented in the pathology report as t [X;18])
MRCL: confirmation by the presence of the reciprocal chromosomal translocation t (12;16) (q13;p11) or t(12;22)(q13;q12)
Participant has R/R ovarian cancer that is
platinum resistant OR platinum-sensitive, but the participant is not a candidate for platinum or other SOC therapy
Participant has not received prior checkpoint inhibitor therapy (i.e., naive PD-1/PD-L1 treatment participants)
Participant has R/R solid tumor (melanoma, non-small cell lung cancer
[NSCLC]-adenocarcinoma and squamous cell, or esophageal squamous cell
Participant consents to provide an archival tumor specimen in a tissue block or unstained serial slides prior to IP administration
Participant in phase 2 consents to provide tumor specimen obtained within 56 days prior to first dose of study treatment, as tissue block or unstained serial slides
carcinoma [ESCC]) after available SOC treatment or is not a candidate for SOC
Participant in phase 2 consents to undergoing a tumor biopsy (core needle biopsy or excision) during the treatment period
therapy (single-agent only)
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of <= 2\
Participant with life expectancy of >= 12 weeks at the time of screening
Participant must meet criteria for clinical laboratory tests during screening period
A female participant is eligible to participate if she is not pregnant and at least one of the following conditions apply
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 investigational product (IP) administration
Female participant must not donate ova at screening and throughout the study period and for 6 months after the final IP administration
A male participant 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 IP administration
Male participant must not donate sperm starting at screening and throughout the study period and for 6 months after the final IP administration
Female participant must not be breastfeeding at screening or during the study period
Participant agrees not to participate in another interventional study while on treatment
and for 6 months after the final IP administration
Participant has at least 1 measurable lesion per immune response evaluation criteria in solid tumors (iRECIST). The measurable lesion must be outside the field of radiation if participant had prior radiotherapy < 3 months from the completion of radiation

Exclusion Criteria

Participant has persistent non-hematological toxicities of >= grade 2 (National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0), with symptoms and objective findings from treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation or surgery)
Participant has received any of the following therapies (for inclusion in the study, all abnormalities must have returned to <= grade 1)
Systemic immunomodulators (checkpoint inhibitors)-except the NY-ESO-1 solid tumor (melanoma, NSCLC-adenocarcinoma and squamous cell and ESCC) cohorts, which may have received prior checkpoint inhibitor therapy
Immunosuppressive drugs including steroids <= 14 days prior to treatment
Cytotoxic agents <= 14 days prior to treatment
Investigational agent <= 21 days prior to treatment or 5 half-lives, whichever is shorter
Radiation therapy <= 21 days prior to treatment
Participant has an active autoimmune disease. Participant 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
Participant was discontinued from prior immunomodulatory therapy due to a grade >= 3 toxicity that was mechanistically related (e.g., immune related) to the agent
Participant has known history of serious hypersensitivity reaction to a known ingredient of ASP0739 or pembrolizumab or severe hypersensitivity reaction to treatment with another monoclonal antibody
Participant has clinically active or untreated nervous system metastases. Participants
Participant has a prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years prior to screening visit, 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
with previously treated Central Nervous System (CNS) metastases are eligible
Participant has received a prior allogeneic bone marrow or solid organ transplant
Participant has an active uncontrolled infection within 14 days of treatment
if they are clinically stable and have no evidence of CNS progression by
Participant is known to have human immunodeficiency virus infection
imaging for at least 4 weeks prior to start of study treatment and are not
Participant has active hepatitis B or C or other active hepatic disorder or participant is on hepatitis treatment. Hepatitis C RNA testing is not required in participants with negative hepatitis C antibody testing
requiring immunosuppressive doses of systemic steroids (> 30 mg per day of
Participant has any condition which makes the participant unsuitable for study participation
hydrocortisone or > 10 mg per day of prednisone or equivalent) for longer than
Participant has had a major surgical procedure and has not completely recovered within 28 days prior to the start of study treatment
weeks
Participant 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
Participant is expected to require another form of anti-cancer therapy while on study treatment
Participants for the combination therapy arm cohorts must not have known microsatellite instability or deficient MisMatch Repair
Additional Exclusion Criteria for Participants in Combination Therapy Cohorts
Participants with a history of myocarditis or congestive heart failure (as defined by New York Heart Associated Functional Classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction 6 months prior to study entry
Participants with active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids
Participants with baseline pulse oximetry < 92% "on Room air
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