A First-in-Human Trial of DS3790a in Participants with Hematological Malignancies.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Daiichi Sankyo Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-02-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Daiichi Sankyo, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic, Therapy

The primary objective of this study will assess the safety and preliminary efficacy of DS3790a monotherapy and combination regimens.

Conditions and MedDRA coding

Hematological Malignancies

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. 1. Sign and date the Informed Consent Form (ICF), prior to the start of any trial-specific procedures.
2. 2. Adults ≥18 years at the time the ICF is signed.
3. 3. History of one of the histologically documented hematologic malignancies according to the 5th edition of World Health Organization classification as specified in the protocol.
4. 4. Agree to provide baseline tumor tissue samples as specified in the protocol.
5. 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1 or 2 assessed no more than 14 days prior to initiation of trial intervention.
6. 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. 7. Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition scan within 28 days before the trial starts.
8. 8. Life expectancy of at least 3 months.
9. 9. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other trial procedures, and trial restrictions.
10. 10. A woman of childbearing potential is eligible to participate if she meets all criteria as specified in the protocol.
11. 11. A male participant capable of producing sperm is eligible to participate if he agrees to all criteria as specified in the protocol.

Exclusion criteria 12

1. 1. Prior allogeneic stem cell transplantation.
2. 2. Prior solid organ transplantation.
3. 3. Inadequate washout period before initiation of trial intervention as specified in the protocol.
4. 4. Evidence of brain or leptomeningeal disease (spinal cord or central nervous system 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. 5. Uncontrolled or significant cardiovascular disease as specified in the protocol.
6. 6. Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
7. 7. Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
8. 8. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
9. 9. Has been diagnosed with another malignancy within the previous 3 years.
10. 10. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and lymphocytopenia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, Grade ≤1 or baseline.
11. 11. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
12. 12. Has active or uncontrolled hepatitis B virus, hepatitis C virus, or human immunodeficiency virus infections.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. 1. Number of Participants Reporting Dose-limiting Toxicities, Treatment-emergent Adverse Events, Serious Adverse Events, Adverse Events of Special Interest, and Deaths in Participants With Hematological Malignancies. Adverse events (AEs) will be graded using NCI-CTCAE version 5.0.
2. 2. Complete Response in Participants With Hematological Malignancies by Blinded Independent Central Review (Cohort A Randomization Optimization Phase, Cohort A Phase 2). Complete Response (CR) is defined as participants with CR as measured by Blinded Independent Central Review assessment.
3. 3. Complete Response in Participants With Hematological Malignancies by Investigator Assessment (Cohort B Randomization Optimization Phase). Complete Response (CR) is defined as participants with CR as measured by investigator assessment.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Daiichi Sankyo Inc.

Sponsor organisation

Daiichi Sankyo Inc.

Address

211 Mount Airy Road

City

Basking Ridge

Postcode

07920-2311

Country

United States

Scientific contact point

Organisation

Daiichi Sankyo Inc.

Contact name

Clinical Trial Office

Public contact point

Organisation

Daiichi Sankyo Inc.

Contact name

Clinical Trial Office

Third parties 18

Locations

2 EU/EEA countries · 4 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications