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

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

Inoguchi Akihiro

Daiichi Sankyo Co., Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

dsclinicaltrial_jp@daiichisankyo.com

Contact for Clinical Trial Information

Daiichi Sankyo Co., Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial_jp@daiichisankyo.com

Recruiting

Nov. 15, 2025

Interventional

randomized controlled trial

open(masking not used)

active control

single assignment

treatment purpose

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.

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.

Both

Hematological Malignancies

Experimental:
- Monotherapy Dose Escalation Phase
Participants with hematological malignancies who received DS3790a monotherapy.

- Monotherapy Dose Expansion Phase
Participants with hematological malignancies who received DS3790a monotherapy.

- Cohort A Combination Dose-escalation Phase
Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.

- Cohort A Randomization/Optimization Phase
Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.

- Cohort A Phase 2
Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.

- Cohort B Combination Dose-escalation Phase
Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.

- Cohort B Randomization/Optimization Phase
Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen.

Active Comparator:
- Standard of Care
Participants with hematological malignancies who received standard of care (SoC).


Drug: DS3790a
Administered as specified in the protocol.

Drug: Combination drug
Administered as specified in the protocol.

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
[Time Frame: Baseline up to 5 years]
Adverse events (AEs) will be graded using NCI-CTCAE version 5.0.

2. Complete Response in Participants With Hematological Malignancies by Blinded Independent Central Review (Cohort A Randomization Optimization Phase, Cohort A Phase 2)
[Time Frame: Baseline up to 5 years]
Complete Response (CR) is defined as participants with CR as measured by BICR assessment.

3. Complete Response in Participants With Hematological Malignancies by Investigator Assessment (Cohort B Randomization Optimization Phase)
[Time Frame: Baseline up to 5 years]
Complete Response (CR) is defined as participants with CR as measured by investigator assessment.

1. Objective Response by Investigator Assessment In Participants With Hematological Malignancies [Time Frame: Baseline up to 5 years]
Objective response (OR) is defined as participants with complete response (CR) or partial response (PR) as measured by investigator assessment.

2. Complete Response in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation) [Time Frame: Baseline up to 5 years]
Complete response (CR) is defined as participants with CR as best overall response (BOR) as measured by investigator assessment.

3. Disease Control in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation) [Time Frame: Baseline up to 5 years]
Disease control (DC) is defined as participants with CR, PR or stable disease as BOR as measured by investigator assessment.

4. 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) [Time Frame: Baseline up to 5 years]
Duration 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. oR will be calculated for responders (CR or PR) only.

5. Time to Response in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation) [Time Frame: Baseline up to 5 years]
Time 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.

6. Progression-free Survival Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation) [Time Frame: Baseline up to 5 years]
Progression-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.

7. Overall Survival Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation) [Time Frame: Baseline up to 5 years]
Overall 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.

+81-3-3542-2511

Oct. 31, 2025

Yes

De-identified individual participant data (IPD) on completed studies 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/ Supporting Information: -Study Protocol -Statistical Analysis Plan (SAP) -Informed Consent Form (ICF) Time Frame: Completed studies that has 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. URL: https://vivli.org/ourmember/daiichi-sankyo/

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