A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies

NCT07220616 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: DS3790-0762025-522595-87-00
• Study Type: interventional
• Target: 420
• Locations: 2 countries
• Sites: 4

Brief Summary

This clinical trial is designed to assess the safety, preliminary efficacy, and pharmacokinetics (PK) of DS3790a monotherapy and combination regimens in participants with hematological malignancies.

Conditions

Hematological Malignancies

Keywords

Hematological Malignancies; DS3790a

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline up to 5 years

• 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 BICR assessment.

  Baseline up to 5 years

• 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.

  Baseline up to 5 years

Secondary Outcomes (7)

• Objective Response by Investigator Assessment In Participants With Hematological Malignancies

  Baseline up to 5 years

• Complete Response in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation)

  Baseline up to 5 years

• Disease Control in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation)

  Baseline up to 5 years

• Duration of Complete Response and Duration of Response in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation)

  Baseline up to 5 years

• Time to Response in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation)

  Baseline up to 5 years

Study Arms (8)

Monotherapy Dose Escalation Phase

EXPERIMENTAL

Participants with hematological malignancies who received DS3790a monotherapy.

Drug: DS3790a

Monotherapy Dose Expansion Phase

EXPERIMENTAL

Participants with hematological malignancies who received DS3790a monotherapy.

Drug: DS3790a

Cohort A Combination Dose-escalation Phase

EXPERIMENTAL

Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.

Drug: DS3790a; Drug: Combination drug

Cohort A Randomization/Optimization Phase

EXPERIMENTAL

Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.

Drug: DS3790a; Drug: Combination drug

Cohort A Phase 2

EXPERIMENTAL

Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.

Drug: DS3790a; Drug: Combination drug

Cohort B Combination Dose-escalation Phase

EXPERIMENTAL

Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.

Drug: DS3790a; Drug: Combination drug

Cohort B Randomization/Optimization Phase

EXPERIMENTAL

Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.

Drug: DS3790a; Drug: Combination drug

Standard of Care

ACTIVE COMPARATOR

Participants with hematological malignancies who received standard of care (SoC).

Drug: Combination drug

Interventions

DS3790a DRUG

Administered as specified in the protocol

Cohort A Combination Dose-escalation Phase; Cohort A Phase 2; Cohort A Randomization/Optimization Phase; Cohort B Combination Dose-escalation Phase; Cohort B Randomization/Optimization Phase; Monotherapy Dose Escalation Phase; Monotherapy Dose Expansion Phase

Combination drug DRUG

Administered as specified in the protocol

Cohort A Combination Dose-escalation Phase; Cohort A Phase 2; Cohort A Randomization/Optimization Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (4)

Research Site

New York, New York, 10065, United States

RECRUITING

Aichi Cancer Center Hospital

Nagoya, 464-8681, Japan

RECRUITING

Research Site

Tokyo, 104-0045, Japan

RECRUITING

Research Site

Tokyo, 135-8550, Japan

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Drug Combinations

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Central Study Contacts

Daiichi Sankyo Contact for Clinical Trial Information

CONTACT

908-992-6400; CTRinfo_us@daiichisankyo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2025
• First Posted: October 24, 2025
• Study Start: January 16, 2026
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): November 30, 2030
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Completed studies that have reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

US (1); JP (3)