A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors
← catalyst calendarNCT02099058 · readout ≤ 12 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
237actual
Sites
36
Countries
Belgium, Finland, France +6
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2014-01-15 | actual | When the study began enrolling |
| Primary completion | Aug 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2014-03-28 | estimated | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-08-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Advanced Solid Tumors Cancer
Interventions
- Drug: Osimertinib
- Drug: Nivolumab
- Drug: Telisotuzumab vedotin — also filed as ABBV-399
- Drug: Telisotuzumab vedotin — also filed as ABBV-399
- Drug: Erlotinib
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Adverse Events
measured Up to 24 Months
Recommended Phase 2 Dose (RPTD) of ABBV-399 when Administered as Monotherapy and in Combination with Osimertinib, Erlotinib or Nivolumab
measured Up to 24 Months
Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)
measured Up to 24 months
Maximum observed plasma concentration (Cmax)
measured Up to 24 months
Time to Cmax (Tmax)
measured Up to 24 months
Terminal elimination half life
measured Up to 24 months
Publications
- PMID 39805351 — linked by the registry
- PMID 36288547 — linked by the registry
- PMID 34426443 — linked by the registry
- PMID 30285518 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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