Trials / Completed
CompletedNCT04196283
A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 1b, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Subjects With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of this study is to assess safety, tolerability, and pharmacokinetics (PK) of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod, nab-paclitaxel, and ABBV-181 in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABBV-368 | Intravenous (IV) infusion |
| DRUG | Tilsotolimod | Intratumoral (IT) injection |
| DRUG | Nab-paclitaxel | Intravenous (IV) infusion |
| DRUG | ABBV-181 | Intravenous (IV) infusion |
Timeline
- Start date
- 2020-01-22
- Primary completion
- 2022-10-27
- Completion
- 2022-10-27
- First posted
- 2019-12-12
- Last updated
- 2023-02-27
Locations
26 sites across 6 countries: United States, France, Germany, Israel, Netherlands, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04196283. Inclusion in this directory is not an endorsement.