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Antibody-Drug Conjugate

IMGN632 + Venetoclax/Azacitidine for Acute Myeloid Leukemia

Phase 1 & 2

Recruiting

Research Sponsored by ImmunoGen, Inc.

Eligibility Criteria Checklist

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

Must have

Patients must have CD123-positive AML as confirmed by local flow cytometry (or immunohistochemistry [IHC]).

Left ventricular ejection fraction (LVEF) ≥ 45% for patients enrolling in Regimens A-D based on locally available assessment, eg, echocardiogram or other modality.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 20 months

Awards & highlights

Study Summary

This trial is testing a new cancer drug, IMGN632, to see if it is safe and effective when used alone or with other drugs to treat acute myeloid leukemia (AML).

Who is the study for?

Adults with CD123-positive Acute Myeloid Leukemia (AML) who have either relapsed or are treatment-naive can join this trial. They must be fit for experimental therapy, not have acute promyelocytic leukemia, and should not have had certain prior treatments. Participants need normal organ function and controlled previous cancers if any.Check my eligibility

What is being tested?

The safety and effectiveness of IMGN632 alone or combined with azacitidine and/or venetoclax in treating AML are being tested. This study is open-label, meaning everyone knows which treatment they're getting, and it's happening at multiple centers.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system due to monoclonal antibodies like IMGN632, liver issues from azacitidine or venetoclax, blood count changes, fatigue, digestive problems, and potential increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My AML is CD123-positive as confirmed by tests.

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My heart pumps well, with an ejection fraction of 45% or higher.

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I have had up to 2 previous cancer treatments.

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I am in complete remission but still have minimal disease, with no more than 2 prior treatments.

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I received either intensive or non-intensive treatment for my condition.

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I agree to use contraception during and for 4 months after the study if I can father children.

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My white blood cell count is below 25,000 per microliter.

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My AML has returned or didn't respond to treatment and tests positive for CD123.

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My previous cancer is under control, and I finished all treatments over 6 months ago.

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I have not received any treatment for my condition, especially with hypomethylating agents.

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I have had treatments targeting CD123 before, but not IMGN632, and CD123 is still detectable in my tests.

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My side effects from previous treatments have mostly gone away.

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My kidney function, measured by eGFR or creatinine clearance, is above 30 mL/min.

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I can carry out all my self-care but may not be able to do heavy physical work.

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I had a bone marrow transplant over 4 months ago, have no severe graft disease, and haven't been on immunosuppressants for 2 weeks.

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I have been diagnosed with AML, not including acute promyelocytic leukemia.

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I am a woman who can have children and agree to use birth control during and 7 months after the study.

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I am 18 years old or older.

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My doctor thinks this experimental therapy is right for me after considering all standard treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 20 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 20 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 20 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Minimal Residual Disease Levels

Preliminary antileukemia activity

Safety and Tolerability

Secondary outcome measures

Anti-drug Antibody Concentration (Dose Escalation and Expansion)

Minimal Residual Disease Levels (Dose Escalation)

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (Dose Expansion Phase)

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Regimen D (Closed to Enrollment)Experimental Treatment1 Intervention

IMGN632, administered intravenously on Day 1 of a 21 day cycle at 0.045 mg/kg, as a monotherapy for Fit and Unfit MRD+ patients.

Group II: Regimen C - Frontline (Enrolling) & Relapsed / Refractory (Closed to Enrollment)Experimental Treatment3 Interventions

IMGN632, administered intravenously on Day 7 of a 28 day cycle at 0.015 mg/kg or 0.045 mg/kg, in combination with azacitidine, administered subcutaneously or intravenously daily at 35-75 mg/m2 given for Days 1 to 7 of a 28 day cycle and venetoclax, administered orally daily at 100 mg on Day 1, 200mg on Day 2, and 400 mg on Day 3 up to Day 28 of a 28 day cycle. Alternate schedules with reduced venetoclax administration or reduced azacitidine dose or administration may be explored.

Group III: Regimen B (Closed to Enrollment)Experimental Treatment2 Interventions

IMGN632, administered intravenously on Day 7 of a 21 day cycle at 0.015 mg/kg, 0.045 mg/kg, or 0.09 mg/kg, in combination with venetoclax, administered orally daily at 100 mg on Day 1, 200mg on Day 2, and 400 mg on the day 3 up to Day 21 of a 21 day cycle. Alternate schedules with reduced venetoclax administration may be explored.

Group IV: Regimen A (Closed to Enrollment)Experimental Treatment2 Interventions

IMGN632, administered intravenously on Day 7 of a 28 day cycle at 0.015 mg/kg, 0.045 mg/kg, or 0.09 mg/kg, in combination with azacitidine, administered subcutaneously or intravenously daily at 75 mg/m2 on Days 1 to 7 of a 28 day cycle. Cycle 1 azacitidine dose in subsequent cohorts may be reduced.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Decitabine

FDA approved

Venetoclax

FDA approved

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

ImmunoGen, Inc.Lead Sponsor

31 Previous Clinical Trials

3,513 Total Patients Enrolled

Jazz PharmaceuticalsIndustry Sponsor

248 Previous Clinical Trials

34,067 Total Patients Enrolled

Patrick Zweidler-McKay, MDStudy DirectorImmunoGen, Inc.

2 Previous Clinical Trials

241 Total Patients Enrolled

Media Library

IMGN632 (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT04086264 — Phase 1 & 2

$Acute Myeloid Leukemia Research Study Groups: Regimen D (Closed to Enrollment), Regimen B (Closed to Enrollment), Regimen A (Closed to Enrollment), Regimen C - Frontline (Enrolling) & Relapsed / Refractory (Closed to Enrollment)$