IMGN632 for BPDCN

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: AbbVie

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is an open-label, multi-center, Phase 1/2 study to determine the MTD and assess the safety, tolerability, PK, immunogenicity, and anti-leukemia activity of IMGN632 when administered as monotherapy to patients with CD123+ disease.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for patients with a rare blood cancer called BPDCN. It's open to those who have never had systemic treatment (Cohort 6) or have tried up to three treatments without success (Cohort 1). Participants must show CD123+ on their cancer cells and can't join if they've got CNS disease, severe swelling issues, liver veno-occlusive disease, or suitable standard care options available.

Inclusion Criteria

I have BPDCN and have undergone 1-3 treatments.

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

I have BPDCN and haven't had any systemic therapy yet.

Exclusion Criteria

My doctor thinks standard treatments are right for me, so I'm not eligible for Cohorts 1-5.

I have BPDCN that has spread to my brain or spinal cord.

I haven't had cancer treatment in the last 14 days and have recovered from any side effects.

Treatment Details

Interventions

• IMGN632 (Antibody-Drug Conjugate)

Trial Overview The study tests IMGN632 as a solo treatment for BPDCN. Researchers want to find the highest dose patients can take without serious side effects (MTD), how safe it is, how the body processes it, if it causes immune reactions, and its effectiveness against leukemia.

Participant Groups

Group I: Escalation and Expansion Experimental Treatment 1 Intervention

Escalation: IMGN632 was administered by IV on 2 different schedules for participants with relapsed/refractory AML, ALL, or BPDCN. Expansion: IMGN632 was administered by IV: * Cohort 1: Relapsed or refractory BPDCN participants who have received 1-3 prior systemic therapies (incl. tagraxofusp-erzs and/or any other systemic therapy deemed appropriate for the treatment of BPDCN) * Cohort 2: Relapsed AML * Cohort 3: Relapsed or refractory ALL * Cohort 4: Other relapsed or refractory hematologic malignancies * Cohort 5: Relapsed or refractory AML at alternate dose or schedule * Cohort 6: Pivotal cohort for frontline BPDCN participants who have not received prior systemic therapy and participants with frontline BPDCN who have prior or concomitant hematologic malignancy (PCHM) and have not received prior systemic therapy.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

ImmunoGen, Inc.

Lead Sponsor

Trials

33

Recruited

4,000+