BridgeMD
Tests treatment safety and results for Acute Myeloid Leukemia
Official title A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)
ClinicalTrials.gov ID: NCT06969430
What this study is testing
What is Debio 1562M?
Debio 1562M is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia.
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
- The primary purpose of Phase 1 is to assess the doses studied under Phase 1 (Dose Escalation) Arm A and identify the recommended dose (RD) for further development (Dose optimization). The primary objective of Phase 2 is to evaluate the antileukemic activity of Debio 1562M.
- 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
- For Phase 1-Dose escalation: Relapsed/refractory (R/R) AML (excluding acute promyelocytic leukemia) based on World Health Organization (WHO)...
- For Phase1-Dose optimization and Phase 2: R/R AML (excluding acute promyelocytic leukemia) based on world health organization (WHO) classification...
- Eastern Cooperative Oncology Group performance (ECOG PS) status ≤2.
- Previous treatment-related toxicities must be resolved to ≤Grade 1 (excluding alopecia).
- Individuals with prior autologous or allogeneic bone marrow (BM) transplant are eligible.
You likely can't join if
- Any prior exposure to cluster of differentiation (CD) 37 targeting agents.
- Clinically active infection including known active hepatitis B or C, human immunodeficiency virus infection, or cytomegalovirus or any other known...
- Clinically significant cardiac dysfunction within 6 months before enrollment including New York Heart Association Class III or IV heart failure...
- Clinically significant and active cardiopulmonary disease.
- Other malignancies, except of:
- Hematologic malignancies other than those being investigated for which individuals are not on active antineoplastic therapy
See the full eligibility criteria
- For Phase 1-Dose escalation: Relapsed/refractory (R/R) AML (excluding acute promyelocytic leukemia) based on World Health Organization (WHO) Classification 2022 and relapsed/refractory higher-risk myelodysplastic...
- For Phase1-Dose optimization and Phase 2: R/R AML (excluding acute promyelocytic leukemia) based on world health organization (WHO) classification 2022 for whom no standard therapy of proven benefit is available.
- Eastern Cooperative Oncology Group performance (ECOG PS) status ≤2.
- Previous treatment-related toxicities must be resolved to ≤Grade 1 (excluding alopecia).
- Individuals with prior autologous or allogeneic bone marrow (BM) transplant are eligible.
- Prior allogeneic transplant must meet the following conditions: the transplant must have been performed more than 120 days before the first administration of Debio 1562M, the participant must not have ≥Grade 1 active...
- Adequate renal and hepatic function defined as:
- Estimated glomerular filtration rate (eGFR) ≥60 milliliter per minute (mL/min) based on the chronic kidney disease-Epidemiology Collaboration based on creatinine (CKD-EPIcr) 2021 equation.
- Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN).
- Serum total bilirubin level ≤1.5× ULN (for participants with Gilbert's syndrome or chronic blood transfusions, total bilirubin ≤3.0× ULN).
- Any prior exposure to cluster of differentiation (CD) 37 targeting agents.
- Clinically active infection including known active hepatitis B or C, human immunodeficiency virus infection, or cytomegalovirus or any other known concurrent infectious disease that, in the judgment of the Investigator...
- Clinically significant cardiac dysfunction within 6 months before enrollment including New York Heart Association Class III or IV heart failure, uncontrolled angina, myocardial infraction, severe uncontrolled...
- Clinically significant and active cardiopulmonary disease.
- Other malignancies, except of:
- Hematologic malignancies other than those being investigated for which individuals are not on active antineoplastic therapy
- Nonhematologic malignancies in remission and for which individuals must have completed all antineoplastic therapy at least 6 months before trial treatment start and all treatment-related toxicities must have resolved to...
- Evidence for active central nervous system (CNS) leukemia involvement. If the participant has a prior history of CNS AML, the participant must have at least 2 negative cerebrospinal fluid (CSF) analyses and either a...
- Evidence of peripheral neuropathy Grade ≥2.
- History of hypersensitivity to Debio 1562M (including its components), or any of its excipients.
- Treatment with any antileukemic therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational agent within 14 days or within 5 half-lives of the investigational treatment prior...
- Major surgery within 4 weeks prior to the start of treatment, or participant who have not recovered from side effects of the surgery.
- Pregnancy or breastfeeding. Note: Other Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Grand Rapids, Michigan, United States
- Buffalo, New York, United States
- Columbus, Ohio, United States
- Houston, Texas, United States
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 Duarte, California, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Grand Rapids, Michigan, United States; Buffalo, New York, United States; Columbus, Ohio, United States and 1 more location(s). 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.