At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
ABBV-368 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating ABBV-368, Tilsotolimod, and 2 other interventions for Advanced Solid Tumors Cancer. Completed, enrolled 30 participants across 26 sites in 6 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors Cancer
CountriesFrance, Germany, Israel, Netherlands, Spain, United States
CollaboratorsIdera Pharmaceuticals, Inc.
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedDec 2019
Enrollment StartJan 2020
Primary CompletionOct 2022
TodayJul 2026
First PostedDec 12, 2019
Enrollment StartJan 22, 2020
Primary CompletionOct 27, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 6.6 years ago
Interventions
ABBV-368drug
Intravenous (IV) infusion
Tilsotolimoddrug
Intratumoral (IT) injection
Nab-paclitaxeldrug
Intravenous (IV) infusion
ABBV-181drug
Intravenous (IV) infusion