BridgeMD
A First-in-Human Trial of DS3790a in Participants with Hematological Malignancies.
EU CTIS ID: 2025-522595-87-00
What this study is testing
The primary objective of this study will assess the safety and preliminary efficacy of DS3790a monotherapy and combination regimens.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Sign and date the Informed Consent Form (ICF), prior to the start of any trial-specific procedures.
- 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.
- 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 World Health Organization classification as specified in the protocol.
- 4. Agree to provide baseline tumor tissue samples as specified in the protocol.
You likely can't join if
- 1. Prior allogeneic stem cell transplantation.
- 10. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and lymphocytopenia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (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 hepatitis B virus, hepatitis C virus, or human immunodeficiency virus infections.
- 2. Prior solid organ transplantation.
- 3. Inadequate washout period before initiation of trial intervention as specified in the protocol.
See the full eligibility criteria
- 1. Sign and date the Informed Consent Form (ICF), prior to the start of any trial-specific procedures.
- 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.
- 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 World Health Organization classification as specified in the protocol.
- 4. Agree to provide baseline tumor tissue samples as specified in the protocol.
- 5. Eastern Cooperative Oncology Group Performance Status (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 a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition scan 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.
- 1. Prior allogeneic stem cell transplantation.
- 10. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and lymphocytopenia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (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 hepatitis B virus, hepatitis C virus, or human immunodeficiency virus infections.
- 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 central nervous system 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) interstitial lung disease (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.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Australia
- Korea, Republic of
- United States
- 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Australia; Korea, Republic of; United States; 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 EU CTIS; the study team decides eligibility.