A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies

Inclusion Criteria25

• To be eligible to participate in this trial, an individual must meet all the following criteria:
• Sign and date the ICF, prior to the start of any trial-specific procedures.
• Adults ≥18 years at the time the ICF is signed
• History of one of the histologically documented hematologic malignancies according to the 5th edition of WHO classification as specified in the protocol.
• Agree to provide tumor samples as specified in the protocol.
• ECOG PS of 0, 1 or 2 assessed no more than 14 days prior to initiation of trial intervention.
• Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of trial intervention as specified in the protocol.
• Has an LVEF ≥50% by either an ECHO or MUGA within 28 days before the trial starts.
• Life expectancy of at least 3 months.
• Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other trial procedures, and trial restrictions.
• A woman of childbearing potential is eligible to participate if she meets all criteria as specified in the protocol.
• A male participant capable of producing sperm is eligible to participate if he agrees to all criteria as specified in the protocol.
• An individual who meets any of the following criteria will be excluded from participating in this trial:
• Prior Allo-SCT.
• Prior solid organ transplantation.
• Inadequate washout period before initiation of trial intervention as specified in the protocol
• Evidence of brain or leptomeningeal disease (spinal cord or CNS metastases) based on history and physical examination, unless treated and with radiologically documented lack of progression within 4 weeks prior to initiation of trial intervention.
• Uncontrolled or significant cardiovascular disease as specified in the protocol.
• Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
• Has a history of (noninfectious) ILD/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
• Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
• Has been diagnosed with another malignancy within the previous 3 years
• Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE Version 5.0, Grade ≤1 or baseline.
• Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
• Has active or uncontrolled HBV, HCV, or HIV infections.