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

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

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07220616
Enrollment
420
Registered
2025-10-24
Start date
2026-01-16
Completion date
2030-11-30
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematological Malignancies

Keywords

Hematological Malignancies, DS3790a

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.

Detailed description

DS3790a may be effective in the treatment of patients with hematological malignancies. The primary objective of this study will assess the safety and preliminary efficacy of DS3790a monotherapy and combination regimens.

Interventions

DRUGDS3790a

Administered as specified in the protocol

Administered as specified in the protocol

Sponsors

Daiichi Sankyo
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
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 MalignanciesBaseline up to 5 yearsAdverse events (AEs) will be graded using NCI-CTCAE version 5.0.
Complete Response in Participants With Hematological Malignancies by Blinded Independent Central Review (Cohort A Randomization Optimization Phase, Cohort A Phase 2)Baseline up to 5 yearsComplete Response (CR) is defined as participants with CR as measured by BICR assessment.
Complete Response in Participants With Hematological Malignancies by Investigator Assessment (Cohort B Randomization Optimization Phase)Baseline up to 5 yearsComplete Response (CR) is defined as participants with CR as measured by investigator assessment.

Secondary

MeasureTime frameDescription
Objective Response by Investigator Assessment In Participants With Hematological MalignanciesBaseline up to 5 yearsObjective response (OR) is defined as participants with complete response (CR) or partial response (PR) as measured by investigator assessment.
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 yearsComplete response (CR) is defined as participants with CR as best overall response (BOR) as measured by investigator assessment.
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 yearsDisease control (DC) is defined as participants with CR, PR or stable disease as BOR as measured by investigator assessment.
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 yearsDuration of Complete Response (DoCR) is defined as the time from the date of first documentation of CR to the first documentation of objective tumor progression by investigator assessment or to death due to any cause, whichever occurs first. DoCR will be calculated for responders (CR) only. Duration of Response (DoR) is defined as the time from the date of first documentation of objective response (CR or PR) to the first documentation of objective tumor progression by investigator assessment or to death due to any cause, whichever occurs first. DoR will be calculated for responders (CR or PR) only.
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 yearsTime to Response (TTR) is defined as the time from the date of the start of trial intervention or randomization if randomized, to the date of the first documentation of objective response (CR or PR) by investigator assessment. TTR will be calculated for responders (CR or PR) only.
Progression-free Survival Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation)Baseline up to 5 yearsProgression-free Survival (PFS) is defined as time from the date of the start of trial intervention or randomization if randomized, to the date of radiographic disease progression, defined as the first documented objective PD by investigator assessment or death due to any cause.
Overall Survival Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation)Baseline up to 5 yearsOverall Survival (OS) is defined as the time from the date of the start of trial intervention or randomization if randomized, to the date of death due to any cause.

Countries

Japan, United States

Contacts

CONTACTDaiichi Sankyo Contact for Clinical Trial Information
CTRinfo_us@daiichisankyo.com908-992-6400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026