Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors
← catalyst calendarNCT03821935 · readout ≤ 315 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
364actual
Sites
64
Countries
Australia, Belgium, Canada +11
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 | 2019-02-21 | actual | When the study began enrolling |
| Primary completion | Jun 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2019-01-30 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-05-25 | 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: Livmoniplimab — also filed as ABBV-151
- Drug: Budigalimab — also filed as ABBV-181
Primary outcomes
what the primary-completion date above is the date OFDose Escalation: Recommended Phase 2 Dose (RP2D) Livmoniplimab Monotherapy
measured Up to 28 days after the first dose of Livmoniplimab monotherapy
Dose Escalation: RP2D Livmoniplimab + Budigalimab Combination Therapy
measured Up to 28 days after the first dose of Livmoniplimab and Budigalimab combination therapy
Dose Expansion: Objective Response Rate (ORR)
measured Up to approximately 6 months after the first dose date of last participant in Dose Expansion
Publications
- PMID 39534099 — 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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