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A Phase 1/2, Multicenter, Open-Label, Multi-Cohort, First-in-Human Trial of DS3790a for Hematological Malignancies
Led by Daiichi Sankyo · Updated on 2026-05-08
420
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating DS3790a, alone and in combination with other drugs, for treating patients with hematological malignancies. This trial aims to assess the safety, early effectiveness, and how the body processes DS3790a. The study is open-label, randomized, and includes multiple groups to compare different treatment regimens and standard care. Participants may receive DS3790a as monotherapy or combined with other drugs following specific dosing plans outlined in the protocol. The study includes several phases: dose escalation, dose expansion, combination dose escalation, randomization/optimization, and a phase 2 segment. There is also a group receiving standard care for comparison. Treatments are administered as specified by the trial procedures. During the study, participants will have regular visits for safety checks, lab tests, and assessments of their cancer response using independent and investigator evaluations. Researchers will monitor adverse events, complete and objective response rates, disease control, survival, and other outcomes for up to five years. Participants' heart function, organ health, and tumor samples will be evaluated to ensure safety and treatment effects over time.
CONDITIONS
Brief Title
A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form before starting any trial procedures
- Adults aged 18 years or older at consent
- Histologically confirmed hematologic malignancy as defined by the WHO classification
- Agree to provide tumor samples as required
- ECOG Performance Status of 0, 1, or 2 within 14 days before treatment
- Adequate organ and bone marrow function per local lab tests within 14 days before treatment
- Left ventricular ejection fraction (LVEF) of 50% or higher by ECHO or MUGA within 28 days before treatment
- Life expectancy of at least 3 months
- Willing and able to follow scheduled visits, drug administration, lab tests, and trial procedures
- Women of childbearing potential must meet specific protocol criteria
- Men capable of producing sperm must meet specific protocol criteria
You will not qualify if you...
- Prior allogeneic stem cell transplant
- Prior solid organ transplant
- Inadequate washout period before starting trial treatment
- Evidence of brain or leptomeningeal disease unless treated and stable for 4 weeks
- Uncontrolled or significant cardiovascular disease
- History of certain arterial thromboembolic events within 6 months
- History or current interstitial lung disease or pneumonitis requiring corticosteroids
- Severe pulmonary compromise from other lung illnesses
- Diagnosis of another malignancy within the past 3 years
- Unresolved toxicities from previous cancer therapy above Grade 1 except alopecia
- Ongoing uncontrolled systemic bacterial, fungal, or viral infections
- Active or uncontrolled hepatitis B, hepatitis C, or HIV infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years or until treatment discontinuation
Participants receive DS3790a monotherapy or combination regimens as specified in the protocol to assess safety and preliminary efficacy in hematological malignancies.
Visit frequency varies depending on treatment phase and cohort assignment
Duration - Up to 5 years from baseline
Participants are monitored for safety and disease response after treatment completion.
Regular visits for safety and response assessments
Trial Site Locations
Total: 5 locations
1
Research Site
New York, New York, United States, 10065
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2
Research Site
Lille, France, 59037
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3
Research Site
Nagoya, Japan, 464-8681
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4
Research Site
Tokyo, Japan, 104-0045
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5
Research Site
Tokyo, Japan, 135-8550
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Research Team
D
Daiichi Sankyo Contact for Clinical Trial Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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