DS-3790A for Hematological malignancies

Inclusion criteria

• {"criterion_text":"- 1. Sign and date the Informed Consent Form (ICF), prior to the start of any trial-specific procedures.\n- 10. A woman of childbearing potential is eligible to participate if she meets all criteria as specified in the protocol.\n- 11. A male participant capable of producing sperm is eligible to participate if he agrees to all criteria as specified in the protocol.\n- 2. Adults ≥18 years at the time the ICF is signed.\n- 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.\n- 4. Agree to provide baseline tumor tissue samples as specified in the protocol.\n- 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.\n- 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.\n- 7. Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition scan within 28 days before the trial starts.\n- 8. Life expectancy of at least 3 months.\n- 9. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other trial procedures, and trial restrictions."}

Exclusion criteria

• {"criterion_text":"- 1. Prior allogeneic stem cell transplantation.\n- 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.\n- 11. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.\n- 12. Has active or uncontrolled hepatitis B virus, hepatitis C virus, or human immunodeficiency virus infections.\n- 2. Prior solid organ transplantation.\n- 3. Inadequate washout period before initiation of trial intervention as specified in the protocol.\n- 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.\n- 5. Uncontrolled or significant cardiovascular disease as specified in the protocol.\n- 6. Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.\n- 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.\n- 8. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.\n- 9. Has been diagnosed with another malignancy within the previous 3 years."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Adverse events (AEs) will be graded using NCI-CTCAE version 5.0; counts of participants reporting DLTs, TEAEs, SAEs, AESIs and deaths will be recorded."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Complete Response (CR) is defined as participants with CR as measured by Blinded Independent Central Review assessment."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Complete Response (CR) is defined as participants with CR as measured by investigator assessment."}

Italy

Earliest CTIS Part Ii Submission Date

10-02-2026

Latest Decision Or Authorization Date

16-02-2026

Processing Time Days

6

Number Of Sites

1

Number Of Participants

10

France

Earliest CTIS Part Ii Submission Date

13-02-2026

Latest Decision Or Authorization Date

12-05-2026

Processing Time Days

88

Number Of Sites

3

Number Of Participants

30

Primary sponsor

Full Name

Daiichi Sankyo Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

WCG Clinical Inc.

Responsibilities

Safety reporting to Investigators

Name

Syneos Health Inc.

Responsibilities

Safety Case Processing

Name

Bioclinica Inc.

Responsibilities

Imaging; ILD Adjudication

Name

Clario

Responsibilities

Centralized ECG Collection

Name

Medpace Finland Oy

Responsibilities

Responsibilities indicated by sponsor duties codes (detailed roles not provided in record)

Name

Fortrea Inc.

Responsibilities

Risk-Based Quality Management

Third parties

• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Safety reporting to Investigators","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Precision For Medicine Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Safety Case Processing","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Clario","duties_or_roles":"Centralized ECG Collection","organisation_type":"Health care"}
• {"country":"United States","full_name":"Foresight Diagnostics, Inc.","duties_or_roles":"","organisation_type":"Industry"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Travel Services","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"ILD Adjudication","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Roche CDx CAP - CLIA Laboratory","duties_or_roles":"","organisation_type":"Industry"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Risk-Based Quality Management","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long term storage for lab samples","organisation_type":"Pharmaceutical company"}