| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04196283 | 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 | PHASE1 | COMPLETED | 30 | — | — | Jan 22, 2020 | Oct 27, 2022 | Feb 27, 2023 | 26 | United States, France +4 |
| NCT03071757 | A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors | PHASE1 | COMPLETED | 139 | — | — | Mar 21, 2017 | Apr 13, 2022 | Apr 28, 2022 | 27 | United States, France +4 |
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.
Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.
Maximum Serum Concentration (Cmax) of ABBV-368
Maximum Observed Plasma Concentration (Cmax) of Tilsotolimod
Maximum Observed Serum Concentration (Cmax) of ABBV-181
Time to Maximum Serum Concentration (Tmax) of ABBV-181
Area Under Serum Concentration-Time Curve of ABBV-181 From Time 0 to the Time of Last Measurable Concentration (AUCt)
Terminal-Phase Elimination Rate Constant (β) of ABBV-181
Terminal Half-Life (t1/2) of ABBV-181
Area under the serum concentration-time curve of ABBV-368
The MTD of ABBV-368 when administered as monotherapy or as combination therapy with ABBV-181 will be determined during the dose escalation phase of the study.
Recommended Phase 2 dose (RPTD) for ABBV-368 when administered as monotherapy or as combination therapy with ABBV-181 will be established during the Dose expansion of the study
Time to Cmax of ABBV-368
Terminal phase elimination rate constant of ABBV-368
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
| Arm | Type | Description |
|---|---|---|
| Arm 1: ABBV-368 + Tilsotolimod | EXPERIMENTAL | Participants will be administered ABBV-368 and Tilsotolimod at various timepoints as described in the protocol. |
| Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxel | EXPERIMENTAL | Participants will be administered ABBV-368, Tilsotolimod and Nab-paclitaxel at various timepoints as described in the protocol. |
| Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181 | EXPERIMENTAL | Participants will be administered ABBV-368, Tilsotolimod, Nab-paclitaxel and ABBV-181 at various timepoints as described in the protocol. |
| Part 1A: Monotherapy Dose Escalation | EXPERIMENTAL | Part 1A: ABBV-368 (various dose levels) intravenous administration every 2 weeks (Q2W). One cycle of treatment is 28 days, thus there will be 2 doses with ABBV-368 per cycle. |
| Part 2A: Monotherapy Cohort Expansion | EXPERIMENTAL | Part 2A: Additional participants (triple negative breast cancer \[TNBC\]) will be enrolled in a dose expansion cohort that will further evaluate ABBV-368 (various dose levels) intravenous administration Q4W. |
| Part 2B: Combination Therapy Cohort Expansion | EXPERIMENTAL | Part 2B: Additional participants (with Head and Neck carcinoma) will be enrolled in a dose expansion cohort that will further evaluate ABBV-368 (various dose levels) intravenous administration Q4W plus ABBV-181. |
| Part 3A: 18F-AraG Imaging Substudy in TNBC Participants | EXPERIMENTAL | Part 3A: Additional participants (with TNBC) will be enrolled in 18F-AraG Imaging Substudy that will further evaluate ABBV-368 intravenous administration Q4W plus ABBV-181. |
| Part 3B: 18F-AraG Imaging Substudy in HNSCC Participants | EXPERIMENTAL | Part 3B: Additional participants (with HNSCC) will be enrolled in 18F-AraG Imaging Substudy that will further evaluate ABBV-368 intravenous administration Q4W plus ABBV-181. |
| Name | Type | Description |
|---|---|---|
| ABBV-368 | DRUG | Intravenous (IV) infusion |
| Tilsotolimod | DRUG | Intratumoral (IT) injection |
| Nab-paclitaxel | DRUG | Intravenous (IV) infusion |
| ABBV-181 | DRUG | Intravenous (IV) infusion |
Inclusion Criteria: * Participants should weigh at least 35 kg. * Eastern Cooperative Oncology Group performance status of 0 or 1 and a life expectancy of \>= 3 months. * Participant have \>= 1 lesion accessible for intratumoral injection. * Histologically or cytologically confirmed R/M HNSCC (of t...