Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 1/Phase 2
Funding Agency/Sponsor
Industrial
Disease
Bone and Soft Tissue Cancers
Enrollment Eligibility
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.
Safety Lead-in, 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 carcinoma
[ESCC]) after available SOC treatment or is not a candidate for SOC therapy
(single-agent only).
- 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.
- Participant in phase 2 consents to undergoing a tumor biopsy (core needle biopsy or
excision) during the treatment period.
- 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 be breastfeeding at screening or during the study period
and for 6 months after the final 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.
- Participant agrees not to participate in another interventional study while on
treatment.
- Participant measurable disease according to RECIST 1.1. For participant with only 1
measurable lesion and prior radiotherapy, the lesion must be outside the field of
prior radiotherapy or must have documented progression following radiation therapy.
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 dose escalation
phase and the NY-ESO-1 solid tumor (melanoma, NSCLC-adenocarcinoma and squamous
cell and ESCC) cohorts in the dose expansion phase of monotherapy, 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 clinically active or untreated nervous system metastases. Participants
with previously treated Central Nervous System (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 or > 10 mg per day of
prednisone or equivalent) for longer than 2 weeks.
- 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 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.
- Participant has received a prior allogeneic bone marrow or solid organ transplant.
- Participant has an active uncontrolled infection within 14 days of treatment.
- Participant is known to have human immunodeficiency virus infection.
- 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.
- Participant has any condition which makes the participant unsuitable for study
participation.
- Participant has had a major surgical procedure and has not completely recovered within
28 days prior to the start of study treatment.
- 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.
- Participant has a known or suspected hypersensitivity to bovine-derived protein or has
suspected hypersensitivity to any ingredients of ASP0739.
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."
- Participants must not have known microsatellite instability-high or deficient MisMatch
Repair.