Clinical trial · Interventional
A Study Evaluating the Safety and Pharmacokinetics of ABBV-744 in Participants With Relapsed/Refractory Acute Myeloid Leukemia (AML) Cancer
A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABBV-744 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategic Reasons
Summary
Brief summary (as posted)
This is an open-label, Phase 1, dose-escalation (Segment 1) and expansion (Segment 2) study to determine the maximum tolerated dose (MTD) and/or the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-744 in participants with relapsed/refractory Acute Myeloid Leukemia (AML).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABBV-744 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ABBV-744 Dose Escalation
- description
- ABBV-744 will be administered at escalating dose levels until the maximum tolerated dose is reached and a recommended Phase 2 dose is determined.
- interventionNames
- Drug: ABBV-744
- type
- EXPERIMENTAL
- label
- ABBV-744 Dose Expansion
- description
- ABBV-744 will be administered at the recommended Phase 2 dose determined during the Dose Escalation phase.
- interventionNames
- Drug: ABBV-744
Primary outcomes (8)
- measure
- Maximum observed plasma concentration (Cmax) of ABBV-744
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participant must have AML not amenable to curative therapy, refractory to standard of care therapy or for which standard of care therapy does not exist. Participants who are candidates for stem cell transplantation must have been offered this therapeutic option. * Must consent to provide biomarker analyses as described in the protocol. * Must have an Eastern Cooperative Oncology Group (ECOG) Performance status of: * Dose Escalation (Segment 1): 0 - 1 * Dose Expansion (Segment 2): 0 - 2 * Dose Escalation: Must have a serum albumin during Screening of \>= 3.0 g/dL. * Participant has adequate bone marrow, renal and hepatic function. Exclusion Criteria: * Participant with known active Central Nervous System (CNS) disease. * Participant has received anti-cancer traditional medicine or anti-cancer herbal remedies within 14 days prior to ABBV-744 dosing. Saw palmetto is considered anti-cancer herbal remedy. Participant has received anti-cancer therapy within a period of 14 days or 5 half-lives (whichever is longer; except for immunotherapy where a period of 21 days will be acceptable) prior to Study Day 1. Except for hydroxyurea which will be allowed during screening and treatment for controlling leukocytosis. * Participant has been previously treated with a Bromodomain and Extra-Terminal (BET) inhibitor * Participant has unresolved clinically significant toxicities from most recent prior anti-cancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE v 4.03) grade 2 or higher clinically significant toxicity (excluding alopecia). * Participant has received the following within 7 days prior to the first dose of study drug: corticosteroid therapy, CYP3A inhibitors, CYP3A inducers. * Participant consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug. * Participant had major surgery within 28 days prior to Study Day 1. * Participant is unable to swallow or absorb oral tablets. * Participant has known infection with hepatitis B or hepatitis C. * Participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis, enteritis, colitis. * Participant has symptoms of gross hematuria or gross hemoptysis * Has electrocardiogram with a QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 470 msec or ECG with second degree type 2 or third degree atrioventricular block.
References
Publications (2)
- DERIVEDCrymes A, Evans MG, Jeyakumar D, Lou JJ, Zhao X, Rezk SA. Acute Myeloid Leukemia (AML) With T-Cell Differentiation Arising From Chronic Myelomonocytic Leukemia (CMML). Case Rep Hematol. 2024 Dec 14;2024:5584297. doi: 10.1155/crh/5584297. eCollection 2024. PMID 39734743
- DERIVEDZhang L, Cai T, Lin X, Huang X, Bui MH, Plotnik JP, Bellin RJ, Faivre EJ, Kuruvilla VM, Lam LT, Lu X, Zha Z, Feng W, Hessler P, Uziel T, Zhang Q, Cavazos A, Han L, Ferguson DC, Mehta G, Shanmugavelandy SS, Magoc TJ, Rowe J, Goodwin NC, Dorritie KA, Boyiadzis M, Albert DH, McDaniel KF, Kati WM, Konopleva M, Shen Y. Selective Inhibition of the Second Bromodomain of BET Family Proteins Results in Robust Antitumor Activity in Preclinical Models of Acute Myeloid Leukemia. Mol Cancer Ther. 2021 Oct;20(10):1809-1819. doi: 10.1158/1535-7163.MCT-21-0029. Epub 2021 Jul 12. PMID 34253595