First-in-human test of DS3790a for hematological malignancies

A Phase 1/2, Multicenter, Open-Label, Multi-Cohort, First-in Human Trial of DS3790a, for Hematological Malignancies

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
• Enrollment: 420 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Daiichi Sankyo (industry)
• Locations: 5 sites (New York, New York and 4 other locations)
• Trial ID: NCT07220616 on ClinicalTrials.gov

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).

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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. 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.

Where this trial is running

New York, New York and 4 other locations

• Research Site — New York, New York, United States (RECRUITING)
• Research Site — Lille, France (RECRUITING)
• Research Site — Nagoya, Japan (RECRUITING)
• Research Site — Tokyo, Japan (RECRUITING)
• Research Site — Tokyo, Japan (RECRUITING)

Study contacts

• Study coordinator: Daiichi Sankyo Contact for Clinical Trial Information

Conditions: Hematological Malignancies, DS3790a