A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies
NCT ID: NCT07220616
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
420 participants
INTERVENTIONAL
2026-01-15
2030-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Monotherapy Dose Escalation Phase
Participants with hematological malignancies who received DS3790a monotherapy.
DS3790a
Administered as specified in the protocol
Monotherapy Dose Expansion Phase
Participants with hematological malignancies who received DS3790a monotherapy.
DS3790a
Administered as specified in the protocol
Cohort A Combination Dose-escalation Phase
Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
DS3790a
Administered as specified in the protocol
Combination drug
Administered as specified in the protocol
Cohort A Randomization/Optimization Phase
Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
DS3790a
Administered as specified in the protocol
Combination drug
Administered as specified in the protocol
Cohort A Phase 2
Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
DS3790a
Administered as specified in the protocol
Combination drug
Administered as specified in the protocol
Cohort B Combination Dose-escalation Phase
Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
DS3790a
Administered as specified in the protocol
Combination drug
Administered as specified in the protocol
Cohort B Randomization/Optimization Phase
Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.
DS3790a
Administered as specified in the protocol
Combination drug
Administered as specified in the protocol
Standard of Care
Participants with hematological malignancies who received standard of care (SoC).
Combination drug
Administered as specified in the protocol
Interventions
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DS3790a
Administered as specified in the protocol
Combination drug
Administered as specified in the protocol
Combination drug
Administered as specified in the protocol
Eligibility Criteria
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Inclusion Criteria
2. Adults ≥18 years at the time the ICF is signed
3. History of one of the histologically documented hematologic malignancies according to the 5th edition of WHO classification as specified in the protocol.
4. Agree to provide tumor samples as specified in the protocol.
5. ECOG PS of 0, 1 or 2 assessed no more than 14 days prior to initiation of trial intervention.
6. 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.
7. Has an LVEF ≥50% by either an ECHO or MUGA within 28 days before the trial starts.
8. Life expectancy of at least 3 months.
9. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other trial procedures, and trial restrictions.
10. A woman of childbearing potential is eligible to participate if she meets all criteria as specified in the protocol.
11. 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:
1. Prior Allo-SCT.
2. Prior solid organ transplantation.
3. Inadequate washout period before initiation of trial intervention as specified in the protocol
4. 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.
5. Uncontrolled or significant cardiovascular disease as specified in the protocol.
6. Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
7. 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.
8. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
9. Has been diagnosed with another malignancy within the previous 3 years
10. 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.
11. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
12. Has active or uncontrolled HBV, HCV, or HIV infections.
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Locations
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Research Site
Tokyo, , Japan
Research Site
Tokyo, , Japan
Countries
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Central Contacts
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Facility Contacts
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Principal Investigator
Role: primary
Principal Investigator
Role: primary
Other Identifiers
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DS3790-076
Identifier Type: -
Identifier Source: org_study_id
2025-522595-87-00
Identifier Type: CTIS
Identifier Source: secondary_id