A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies
Purpose
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.
Condition
- Hematological Malignancies
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Monotherapy Dose Escalation Phase |
Participants with hematological malignancies who received DS3790a monotherapy. |
|
|
Experimental Monotherapy Dose Expansion Phase |
Participants with hematological malignancies who received DS3790a monotherapy. |
|
|
Experimental Cohort A Combination Dose-escalation Phase |
Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen. |
|
|
Experimental Cohort A Randomization/Optimization Phase |
Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen. |
|
|
Experimental Cohort A Phase 2 |
Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen. |
|
|
Experimental Cohort B Combination Dose-escalation Phase |
Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen. |
|
|
Experimental 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). |
|
Recruiting Locations
New York, New York 10065
Principal Investigator
More Details
- Status
- Recruiting
- Sponsor
- Daiichi Sankyo
Study Contact
Daiichi Sankyo Contact for Clinical Trial Information908-992-6400
CTRinfo_us@daiichisankyo.com
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.