134 Participants Needed

Debio 1562M for Acute Myeloid Leukemia

Recruiting at 2 trial locations
DI
Overseen ByDebiopharm International S.A
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Debiopharm International SA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.
See 6 more

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?
3Treatment groups
Experimental Treatment
Group I: Phase 2: Debio 1562MExperimental Treatment1 Intervention
Group II: Phase 1 (Dose Optimization): Debio 1562MExperimental Treatment1 Intervention
Group III: Phase 1 (Dose Escalation): Debio 1562MExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Debiopharm International SA

Lead Sponsor

Trials
53
Recruited
7,300+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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