DS3790a: Administered as specified in the protocol
Combination drug: Administered as specified in the protocol
Combination drug: Administered as specified in the protocol
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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. NHL participants only: Agree to provide baseline tumor tissue 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 including, but not limited to, any underlying pulmonary disorder and any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement, or prior pneumonectomy.
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 and lymphocytopenia) 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.
Primary outcome measure(s)
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 — Baseline up to 5 years Adverse 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 years Complete 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 years Complete Response (CR) is defined as participants with CR as measured by investigator assessment.
Trial sites (8)
Facility
City
Region
Status
Research Site
New York
New York
Recruiting
Research Site
Lille
France
Recruiting
Research Site
Pierre-Bénite
France
Recruiting
Research Site
Villejuif
France
Recruiting
Research Site
Bologna
Italy
Recruiting
Research Site
Nagoya
Japan
Recruiting
Research Site
Tokyo
Japan
Recruiting
Research Site
Tokyo
Japan
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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