Phase
Condition
Neoplasms
Treatment
DS-1471a
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
The clinical site will screen for the full inclusion criteria per protocol.
Sign and date the informed consent form (ICF)
Adults ≥18 years at the time the ICF is signed
Has a histologically or cytologically documented, locally advanced, metastatic, orunresectable solid tumor that is refractory to or intolerable with standardtreatment, or for which no standard treatment is available
Has at least 1 measurable lesion according to RECIST v1.1 1 on computed tomography (CT) or magnetic resonance imaging (MRI)
Is willing and able to provide tumor tissue (newly obtained or archived)
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
Life expectancy ≥3 months
Has a left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to Cycle 1Day 1
Required baseline local laboratory data (within 7 days prior to Cycle 1 Day 1) asprespecified in the protocol
A female participant of childbearing potential is eligible to participate if thefollowing conditions are met:
Not pregnant as confirmed by highly sensitive pregnancy test within 7 daysprior to study drug administration (Cycle 1 Day 1)
Agrees to adhere to a highly effective contraceptive method and agrees not todonate eggs or freeze/store eggs, during the intervention period, and for 7months following the last dose of study drug
A male participant is eligible to participate if he agrees to the following duringthe intervention period and for 4 months following the last dose of study drug:
Avoid donating sperm
Adhere to either abstinence or use of a condom during intercourse with anonparticipant of childbearing potential PLUS partner use of an additionalcontraceptive method
Is willing and able to comply with scheduled visits, study drug administration plan,laboratory tests, other study procedures, and study restrictions
Patients with liver cirrhosis and liver cancer may be eligible to participate ifthey meet additional protocol specified criteria
Exclusion
Key Exclusion Criteria:
The clinical site will screen for the full exclusion criteria per protocol.
Has an inadequate treatment washout period prior to start of study treatment (Cycle 1 Day 1) as prespecified in the protocol
Has history of or current presence of untreated central nervous system (CNS)metastases
Has a history of leptomeningeal carcinomatosis
Has a history of (non-infectious) interstitial lung disease (ILD) other thanradiation pneumonitis, currently has ILD, or when suspected ILD cannot be ruled outby imaging at screening
Clinically severe pulmonary compromise resulting from intercurrent pulmonaryillnesses
Has any of the following within the past 6 months: cerebrovascular accident,transient ischemic attack, arterial thromboembolic event, or pulmonary embolism
Has uncontrolled or clinically significant cardiovascular disease
Is requiring chronic steroid treatment (>10 mg daily prednisone equivalents)
Has multiple primary malignancies, except adequately resected non-melanoma skincancer, curatively treated in situ disease, superficial cancer in thegastrointestinal tract curatively resected by endoscopic surgery, or any other solidtumors curatively treated with no evidence of recurrent disease for ≥3 years
Has unresolved toxicities from previous anticancer treatment
Exposure to another investigational medical product within 4 weeks prior to Cycle 1Day 1 or current participation in other therapeutic investigational procedures
Has an active, known, or suspected autoimmune disease
Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
Has an active hepatitis or uncontrolled hepatitis B or C infection, except forparticipants with hepatitis B infection that is controlled by antiviral therapy
For the Dose Escalation phase, has human immunodeficiency virus (HIV) infection. Forthe Dose Expansion phase, has active or uncontrolled HIV infection with exceptionsper protocol.
Has received a live, attenuated vaccine (messenger RNA [mRNA] andreplication-deficient adenoviral vaccines are not considered live, attenuatedvaccines) within 30 days prior to first exposure to study drug (Cycle 1 Day 1)
Female who is pregnant or breastfeeding or intends to become pregnant during thestudy
Has psychological, social, familial, or geographical factors that would preventregular follow-up
Has prior or ongoing clinically relevant illness, medical condition, surgicalhistory, physical finding, or laboratory abnormality that, in the investigator'sopinion, could affect the safety of the subject; alter the absorption, distribution,metabolism, or excretion of the study drug; or confound the assessment of studyresults
Study Design
Study Description
Connect with a study center
National Cancer Center Hospital East
Chiba, 277-8577
JapanActive - Recruiting
National Cancer Center Hospital
Tokyo, 104-0045
JapanActive - Recruiting
Florida Cancer Specialist
Sarasota, Florida 34236
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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