abbv-744 in patients with aml - abbvie oncology · to learn more about these studies, please visit...

To learn more about these studies, please visit https://ClinicalTrials.gov or email abbvieclinicaltrials@abbvie.com

©2018 AbbVie Inc. North Chicago, IL 60064 May 2018 Printed in U.S.A.

ABBV-744 is an investigational agent not approved by FDA or any regulatory health agencies. Safety and Efficacy have not been established.

https://clinicaltrials.gov/ct2/show/NCT03360006 (accessed April 2018)

To learn more about our pipeline, please visit www.abbviescience.com/oncology

Phase 1 (M16-415)ABBV-744 in Patients with AML

Endpoints

Primary Endpoints• Dose Limiting Toxicity (AE / DLT) • Maximum Tolerated

Dose / Recommended Phase 2 Dose (MTD / R2PD)

• Pharmacokinetics (PK) Secondary Endpoints• Objective Response Rate (ORR)• Duration of Response (DOR)• Progression-free Survival (PFS)

Key Inclusion Criteria

• AML, relapsed or refractory to standard of care therapy, or for which standard of care therapy does not exist

• ECOG 0-1• Adequate hepatic and

renal function

Key Exclusion Criteria

• Unresolved clinically significant toxicities from previous treatments, e.g., GVHD

• Active CNS disease• History of prolonged QT interval• Active peptic ulcer disease,

esophagitis, gastritis, enteritis, colitis

N=20Dose

EscalationN=20

Dose Expansion

N=TBD

A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABBV-744 in Subjects With Metastatic Castrate-Resistant Prostate Cancer (CRPC) and Relapsed / Refractory Acute Myeloid Leukemia (AML)

ABBV-US-00003-E