Debio 1562M for Acute Myeloid Leukemia

Recruiting at 6 trial locations

Overseen By Debiopharm International S.A

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Debiopharm International SA

Must not be taking: Antileukemic therapy

Disqualifiers: Active infection, Cardiac dysfunction, CNS leukemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

134 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, Debio 1562M, for individuals with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). In the first phase, researchers aim to determine the correct dose, while the second phase evaluates the treatment's effectiveness against the cancer. The trial may suit those with AML or high-risk MDS that has not responded to other treatments. As a Phase 1/Phase 2 trial, participants will be among the first to receive this treatment and help assess its effectiveness against AML and high-risk MDS.

Will I have to stop taking my current medications?

The trial requires that you stop taking any antileukemic therapy, including chemotherapy, immunotherapy, and other treatments, at least 14 days before starting the trial. However, you can continue using hydroxyurea to control leukocytosis before and after starting the trial.

Is there any evidence suggesting that Debio 1562M is likely to be safe for humans?

Research has shown that Debio 1562M holds promise for treating acute myeloid leukemia (AML). In studies, this treatment demonstrated strong effects against tumors and was generally well-tolerated by patients. As a targeted therapy, it focuses on specific cancer cells, potentially reducing side effects.

Reports indicate that it has a safe profile, meaning it doesn't cause serious harm to the body. However, since this is an early-stage trial, not all possible side effects and safety details are known. Participants receive the treatment every three weeks while researchers continue to assess its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Debio 1562M for treating acute myeloid leukemia (AML) because it offers a novel approach compared to traditional chemotherapy and targeted therapies like FLT3 inhibitors. Unlike existing treatments, Debio 1562M is designed to be administered intravenously in a controlled, escalating dose schedule, potentially optimizing its effectiveness and minimizing side effects. Its unique mechanism of action targets specific pathways involved in AML progression, which might offer improved outcomes for patients not responding well to current options. This innovative approach could lead to more personalized treatment plans and better management of the disease.

What evidence suggests that Debio 1562M might be an effective treatment for acute myeloid leukemia?

Research has shown that Debio 1562M could be very effective in treating acute myeloid leukemia (AML). Early studies demonstrated its effectiveness against all types of AML, surpassing current treatments. This drug represents a new type of targeted cancer therapy and has been tested in labs and on animals. It proved highly effective at shrinking tumors, with some tumors disappearing completely. Debio 1562M also appears safe, making it a strong candidate for further testing. These results suggest that Debio 1562M could be a promising treatment option for AML. Participants in this trial will receive Debio 1562M in different phases, including dose escalation, dose optimization, and a phase 2 study to determine its effectiveness and safety. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndrome who have not responded to other treatments. Participants must be in relatively stable condition, with an ECOG performance status of ≤2, and have resolved any previous treatment-related issues to a mild level. Those who've had bone marrow transplants can join if they meet certain conditions regarding recovery time and absence of graft versus host disease.

Inclusion Criteria

My kidney function is normal or only mildly reduced.

I have had a bone marrow transplant before.

I can perform daily activities with minimal assistance.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Dose Escalation

Participants receive Debio 1562M intravenously in escalating doses every 3 weeks during each 21-day treatment cycle

Varies until progression or unacceptable toxicity

Phase 1: Dose Optimization

Participants are randomized to receive one of the 2 selected doses from Phase 1 for further investigation and selection of recommended dose for Phase 2

Varies until progression or unacceptable toxicity

Phase 2

Participants receive the recommended dose of Debio 1562M intravenously every 3 weeks during each 21-day treatment cycle to evaluate antileukemic activity

Varies until progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Debio 1562M

Trial Overview The study is testing Debio 1562M's safety and effectiveness in treating AML. Phase 1 focuses on finding the right dose, while Phase 2 evaluates how well it works against leukemia cells. The trial includes initial dose escalation followed by optimization based on participants' responses.

How Is the Trial Designed?

Group I: Phase 2: Debio 1562M Experimental Treatment 1 Intervention

Participants will receive RD of Debio 1562M based on the results from Phase 1-Dose optimization. Participants will receive Debio 1562M intravenously, once in every 3 weeks (Q3W), during each 21-day treatment cycle until progression of disease, unacceptable toxicity, participant's withdrawal, or Investigator's decision, or end of study whichever occurs first.

Group II: Phase 1 (Dose Optimization): Debio 1562M Experimental Treatment 1 Intervention

Participants will be randomised 1:1 to receive 1 of the 2 Debio 1562M dose(s) and/or dosing schedule(s) selected based on the results from the Phase 1-Dose escalation for further investigation. Participants will be randomized to receive one of the 2 selected doses from Phase 1 (dose escalation) for further investigation and selection of recommended dose (RD) for Phase 2. Participants will receive Debio 1562M intravenously, once in every 3 weeks (Q3W), during each 21-day treatment cycle until progression of disease, unacceptable toxicity, participant's withdrawal, or Investigator's decision, or end of study whichever occurs first.

Group III: Phase 1 (Dose Escalation): Debio 1562M Experimental Treatment 1 Intervention

Participants will receive Debio 1562M intravenously in escalating doses, once in every 3 weeks (Q3W), during each 21-day treatment cycle until progression of disease, unacceptable toxicity, participant's withdrawal, or Investigator's decision, or end of study whichever occurs first.

Who Is Running the Clinical Trial?

Debiopharm International SA

Lead Sponsor

Trials

53

Recruited

7,300+

Citations

1. debiopharm.com debiopharm.com/drug-development/press-releases/debiopharms-adc-research-gains-momentum-with-launch-of-first-in-human-trial-assessing-debio-1562m-in-acute-myeloid-leukemia-patients

Debiopharm's ADC Research Gains Momentum with ... In pre-clinical studies, Debio 1562M showed anti-leukemic activity across all AML subtypes as well as superior activity vs. the current standard ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06969430

NCT06969430 | A Study to Assess the Safety, Tolerability, ... A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML) · Study Overview · Contacts ...

3. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/1542/499677/Debio-1562M-a-Next-Generation-Antibody-Drug

Debio 1562M, a Next Generation Antibody Drug Conjugate ... In this work, we report Debio 1562M specificity and potent antitumor activity in multiple AML models both in vitro and in vivo. First, in our in ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0006497123081454

Debio 1562M, a Next Generation Antibody Drug Conjugate ... In vivo, in 3 different AML cell line xenograft mouse models, a single injection of Debio 1562M at 5mg/kg induced complete tumor regression and ...

5. adcreview.com adcreview.com/conference-coverage/aacr-2025-insights-from-debiopharms-adc-ddr-inhibitor-and-adc-platform-technology-research/

AACR 2025: Insights from Debiopharm's ADC, DDR ... Debio 1562M, a 2ndgeneration ADC targeting CD37, shows high potency against AML and MDS and safe toxicological profile for future clinical development.

6. debiopharm.com debiopharm.com/pipeline/debio-1562m

Debio 1562M The first patient has been dosed in the first-in-human clinical trial evaluating the safety, tolerability, and antileukemic activity of Debio 1562M monotherapy ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123081454

Debio 1562M, a Next Generation Antibody Drug Conjugate ... Debio 1562M is a second-generation novel ADC directed against CD37 and including Debiopharm's proprietary Multilink cleavable linker-payload technology.

8. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/1160/754921/Abstract-1160-Debio-1562M-a-2ndgeneration-ADC

Abstract 1160: Debio 1562M, a 2 nd generation ADC targeting ... Debio 1562M, a 2ndgeneration ADC targeting CD37, shows high potency against AML and MDS and safe toxicological profile for future clinical ...