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NCT06068868
Study to Evaluate Adverse Events and Movement of Intravenously (IV) Infused ABBV-787 in Adult Participants With Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)
Phase 1 trial testing ABBV-787 in Acute Myeloid Leukemia in 36 participants. Terminated before completion.
25 February 2025
Quick facts
| Lead sponsor | AbbVie |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 13 November 2023 |
| Primary completion | 25 February 2025 |
| Estimated completion | 25 February 2025 |
| Sites | 24 locations across Japan, Israel, South Korea, Australia, United States |
Drugs / interventions tested
- ABBV-787 — full drug profile →
Conditions studied
- Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
Sponsor
AbbVie — full company profile →
Who can join
18 and older, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Acute myeloid leukemia (AML) is the second most common type of leukemia diagnosed in adults and children, but most cases occur in adults. This study is to evaluate how safe ABBV-787 is and how it moves within the body in adult participants with relapsed/refractory (R/R) acute myeloid leukemia (AML). Adverse events and maximum tolerated dose (MTD) of ABBV-787 will be assessed. ABBV-787 is an investigational drug being developed for the treatment of AML. Participants will receive ABBV-787 in escalating doses until the maximum tolerated dose (MTD) is determined. Approximately 60 adult participants with a diagnosis of AML will be enrolled worldwide. Participants will receive intravenous (IV) infusions of ABBV-787 during the approximately 3 year duration a participant is followed. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Combination therapy with novel agents for acute myeloid leukaemia: Insights into treatment of a heterogenous disease.
Jen WY, Kantarjian H, Kadia TM, DiNardo CD, et al · · 2024 · cited 32× · PMID 38724457 · DOI 10.1111/bjh.19519
Verify or expand the search:
- PubMed search for NCT06068868
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other AbbVie trials
Trials by the same sponsor.
- NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
- NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
- NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
- NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
- NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06068868 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AbbVie
- Last refreshed: 6 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06068868.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing