Debio 1562M for Acute Myeloid Leukemia

Recruiting at 2 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?

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.

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+