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

Daiichi Sankyo

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Hematological Malignancies

Treatments: Drug: DS3790a; Drug: Combination drug

Study type: Interventional

Funder types: Industry

Identifiers

NCT07220616

DS3790-076

2025-522595-87-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 420 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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420 participants in 8 patient groups

Monotherapy Dose Escalation Phase

Experimental group

Description:

Participants with hematological malignancies who received DS3790a monotherapy.

Treatment:

Drug: DS3790a

Monotherapy Dose Expansion Phase

Experimental group

Description:

Participants with hematological malignancies who received DS3790a monotherapy.

Treatment:

Drug: DS3790a

Cohort A Combination Dose-escalation Phase

Experimental group

Description:

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

Treatment:

Drug: Combination drug

Drug: Combination drug

Drug: DS3790a

Cohort A Randomization/Optimization Phase

Experimental group

Description:

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

Treatment:

Drug: Combination drug

Drug: Combination drug

Drug: DS3790a

Cohort A Phase 2

Experimental group

Description:

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

Treatment:

Drug: Combination drug

Drug: Combination drug

Drug: DS3790a

Cohort B Combination Dose-escalation Phase

Experimental group

Description:

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

Treatment:

Drug: Combination drug

Drug: Combination drug

Drug: DS3790a

Cohort B Randomization/Optimization Phase

Experimental group

Description:

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

Treatment:

Drug: Combination drug

Drug: Combination drug

Drug: DS3790a

Standard of Care

Active Comparator group

Description:

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

Treatment:

Drug: Combination drug

Drug: Combination drug