First-in-human test of DS3790a for hematological malignancies
Official title: A Phase 1/2, Multicenter, Open-Label, Multi-Cohort, First-in Human Trial of DS3790a, a DXd-ADC Targeting CD37, for Hematological Malignancies
Run by Daiichi Sankyo · NCT07220616 · Data updated 2026-11-12
This first-in-human trial will test DS3790a alone and with other drugs to see if it's safe, how it behaves in the body, and whether it helps adults with hematological malignancies.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 420 (estimated) |
| Sponsor | Daiichi Sankyo Industry-sponsored |
| Locations | 8 sites (New York, New York and 7 other locations) |
| Status | Recruiting |
| Started | January 16, 2026 |
| Main results expected | November 30, 2030 |
| Study ends | November 30, 2030 |
| Registry record updated | August 24, 2026 |
| Trial ID | NCT07220616 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with histologically documented hematological malignancies per WHO criteria who have ECOG 0–2, adequate organ and marrow function, LVEF ≥50%, life expectancy ≥3 months, and who can comply with visits and provide tumor samples.
✕Probably not a fit
Patients with poor cardiac function, significant organ or marrow failure, ECOG >2, very limited life expectancy, or those unable or unwilling to comply with protocol procedures are unlikely to qualify or benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 1/2, first-in-human study gives DS3790a as monotherapy and in combination regimens to adults with histologically confirmed hematologic malignancies. The design includes dose-finding (phase 1) and expansion cohorts (phase 2) to characterize safety, preliminary anti-tumor activity, and pharmacokinetics. Key eligibility criteria include ECOG performance status 0–2, adequate organ and bone marrow function, left ventricular ejection fraction ≥50%, and willingness to provide tumor samples. The sponsor is Daiichi Sankyo and study sites include locations in New York (USA), Lille (France), and Nagoya (Japan).
Why it matters
Potential benefit: If successful, DS3790a could become a new treatment option that provides clinical benefit for some patients with hematological malignancies.
How similar studies have gone: While antibody-drug conjugates and other targeted agents have shown efficacy in some blood cancers, DS3790a is first-in-human and its safety and activity in patients are still unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
To be eligible to participate in this trial, an individual must meet all the following criteria: 1. Sign and date the ICF, prior to the start of any trial-specific procedures. 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. NHL participants only: Agree to provide baseline tumor tissue 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 including, but not limited to, any underlying pulmonary disorder and any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement, or prior pneumonectomy. 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 and lymphocytopenia) 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.
Where it's running
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Research Site
New York, New York, United States Recruiting -
Research Site
Lille, France Recruiting -
Research Site
Pierre-Bénite, France Recruiting -
Research Site
Villejuif, France Recruiting -
Research Site
Bologna, Italy Recruiting -
Research Site
Nagoya, Japan Recruiting
Show 2 more locations
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Research Site
Tokyo, Japan Recruiting -
Research Site
Tokyo, Japan Recruiting
Study contacts
- Study coordinator: Daiichi Sankyo Contact for Clinical Trial Information
- Email: CTRinfo_us@daiichisankyo.com
- Phone: 908-992-6400
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.