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DNA Methyltransferase Inhibitor

DSP107 + Azacitidine/Venetoclax for Leukemia

Phase 1

Recruiting

Research Sponsored by Kahr Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Relapsed/refractory AML or MDS/CMML patients who have failed up to 2 prior therapeutic regimens

Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

Must not have

Treatment with any CD47/SIRPα targeting agent or immune agonists

Known allergy or hypersensitivity to any of the test compounds, materials or contraindication to test product

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of treatment cycle 2 (within 2 months of treatment initiation)

Awards & highlights

No Placebo-Only Group

Summary

This trial will enroll patients with relapsed/refractory AML or MDS/chronic myelomonocytic leukemia (CMML) who have failed up to 2 prior therapeutic regimens. Part A is a dose escalation study of a new drug, DSP107, given alone and with azacitidine. Part B is a dose escalation study of DSP107 given with azacitidine and venetoclax.

Who is the study for?

This trial is for patients with certain blood cancers like AML, MDS, or CMML who have tried and failed up to two treatments. They should have a white blood cell count under a specific limit, decent organ function, and be in fair to good physical condition (ECOG 0-2). It's not for those with severe liver disease, recent immunostimulatory treatment, active hepatitis B or C infection, lung issues, pregnancy/breastfeeding intentions during the study period.

What is being tested?

The trial tests DSP107 combined with azacitidine (AZA) in Part A and adds venetoclax (VEN) in Part B. Both parts aim to find safe doses while checking how well these combinations work against the cancer by monitoring their effects on the body and cancer cells.

What are the potential side effects?

Potential side effects of DSP107 include reactions related to immune system activation which could affect various organs. Azacitidine may cause nausea or low blood counts leading to fatigue or infections. Venetoclax can also lower blood counts and might lead to tiredness or bleeding complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My AML or MDS/CMML has not improved after up to 2 treatments.

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I can take care of myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been treated with drugs targeting CD47/SIRPα or immune boosters.

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I am not allergic to any of the materials or drugs used in the test.

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I am experiencing symptoms of graft versus host disease.

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I do not have an active Hepatitis B or C infection.

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I have been diagnosed with acute promyelocytic leukemia.

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I stopped previous immunotherapy due to a severe reaction.

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I have a history of severe lung issues.

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My leukemia is affecting my brain and causing symptoms.

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I have had an organ transplant and am on immunosuppressants.

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I had a severe reaction to previous immunotherapy.

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My liver is not working well and it affects my health significantly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of treatment cycle 2 (within 2 months of treatment initiation)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of treatment cycle 2 (within 2 months of treatment initiation)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of treatment cycle 2 (within 2 months of treatment initiation) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events (AEs)

Dose Limiting Toxicities (DLT)

Response Rate (RR) including Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi)

Secondary study objectives

4-week Mortality Rate

Change in Phenotypic and Activation Profiles of Peripheral Blood Mononuclear Cells

DSP107 Serum Concentration

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: DSP107 in combination with azacitidine or azacitidine plus venetoclax.Experimental Treatment3 Interventions

DSP107 will be administered by intravenous infusion once weekly during each 28-day cycle to all patients in this study. Azacitidine (75 mg/m2/day) will be administered subcutaneously or intravenously for the first 7 days of every cycle. Patients enrolled in Part B only will also receive venetoclax. During Cycle 1, venetoclax will be dose escalated daily to the goal dose of 400 mg daily. Patients will receive 100 mg on Day 1, 200 mg on Day 2 and 400 mg on Day 3 and onwards.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine

2012

Completed Phase 3

~1440

Venetoclax

2019

Completed Phase 3

~2240