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New treatment option for Hematological Malignancies
Official title A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies
ClinicalTrials.gov ID: NCT07220616
What this study is testing
What is DS3790a?
DS3790a is an investigational medicine, being studied as a potential treatment for hematological malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- To be eligible to participate in this trial, an individual must meet all the following criteria:
- Sign and date the ICF, prior to the start of any trial-specific procedures.
- Adults \>=18 years at the time the ICF is signed.
- History of one of the histologically documented hematologic malignancies according to the 5th edition of WHO classification as specified in the...
- NHL participants only: Agree to provide baseline tumor tissue samples as specified in the protocol.
See the full eligibility criteria
- To be eligible to participate in this trial, an individual must meet all the following criteria:
- Sign and date the ICF, prior to the start of any trial-specific procedures.
- Adults \>=18 years at the time the ICF is signed.
- History of one of the histologically documented hematologic malignancies according to the 5th edition of WHO classification as specified in the protocol.
- NHL participants only: Agree to provide baseline tumor tissue samples as specified in the protocol.
- ECOG PS of 0, 1 or 2 assessed no more than 14 days prior to initiation of trial intervention.
- 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.
- Has an LVEF \>=50% by either an ECHO or MUGA within 28 days before the trial starts.
- Life expectancy of at least 3 months.
- Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other trial procedures, and trial restrictions.
- A woman of childbearing potential is eligible to participate if she meets all criteria as specified in the protocol.
- 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...
- Prior Allo-SCT.
- Prior solid organ transplantation.
- Inadequate washout period before initiation of trial intervention as specified in the protocol.
- 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...
- Uncontrolled or significant cardiovascular disease as specified in the protocol.
- Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
- 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.
- 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...
- Has been diagnosed with another malignancy within the previous 3 years.
- 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.
- Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
- Has active or uncontrolled HBV, HCV, or HIV infections.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Lille, France
- Pierre-Bénite, France
- Nagoya, Japan
- Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Lille, France; Pierre-Bénite, France; Nagoya, Japan; Tokyo, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.