Advanced Solid Tumors Cancer
Conditions
Keywords
Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma, Cancer
Brief 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).
Interventions
DRUGABBV-368
Intravenous (IV) infusion
DRUGTilsotolimod
Intratumoral (IT) injection
DRUGNab-paclitaxel
Intravenous (IV) infusion
DRUGABBV-181
Intravenous (IV) infusion
Sponsors
Idera Pharmaceuticals, Inc.
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 the following 4 subsites: oral cavity, oropharynx, larynx, and hypopharynx) who previously progressed either during or after \<= 3 prior treatment regimens administered in the recurrent or metastatic setting. * Must have received 1 immunotherapy regimen which included a PD-(L)1 inhibitor. * Must have received platinum-based therapy, or be considered ineligible for platinum-based therapy by the investigator.
Exclusion criteria
* Uncontrolled metastases to the central nervous system (CNS). * Participants with brain metastases are eligible provided that evidence of clinical and radiographic stable disease for at least 4 weeks after definitive therapy is given and participants have not used prohibited levels of steroids for at least 4 weeks prior to first dose of the study. * Received prior treatment with OX40 or toll-like receptor (TLR) agonists (excluding topical agents).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Terminal Half-Life (t1/2) of ABBV-181 (Arm 3 Only) | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) | Terminal Half-Life (t1/2) of ABBV-181 |
| Terminal Half-Life (t1/2) of Tilsotolimod | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) | Terminal Half-Life (t1/2) of Tilsotolimod |
| Maximum Observed Serum Concentration (Cmax) of ABBV-181 (Arm 3 Only) | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) | Maximum Observed Serum Concentration (Cmax) of ABBV-181 |
| Time to Maximum Serum Concentration (Tmax) of ABBV-181 (Arm 3 Only) | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) | 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) (Arm 3 Only) | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) | 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 (Arm 3 Only) | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) | Terminal-Phase Elimination Rate Constant (β) of ABBV-181 |
| Terminal-Phase Elimination Rate Constant (β) of ABBV-368 | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) | Terminal-Phase Elimination Rate Constant (β) of ABBV-368 |
| Area Under Serum Concentration-Time Curve of ABBV-368 From Time 0 to the Time of Last Measurable Concentration (AUCt) | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) | Area Under Serum Concentration-Time Curve of ABBV-368 From Time 0 to the Time of Last Measurable Concentration (AUCt) |
| Number of Participants with Adverse Events (AEs) | Up to approximately 2 years following the first dose | 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. |
| Change in Vital Signs | Up to approximately 2 years following the first dose | Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported. |
| Change in Clinical Laboratory Test Results | Up to approximately 2 years following the first dose | Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported. |
| Maximum Observed Serum Concentration (Cmax) of ABBV-368 | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) | Maximum Serum Concentration (Cmax) of ABBV-368 |
| Time to Maximum Serum Concentration (Tmax) of ABBV-368 | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) | Time to Maximum Serum Concentration (Tmax) of ABBV-368 |
| Terminal Half-Life (t1/2) of ABBV-368 | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) | Terminal Half-Life (t1/2) of ABBV-368 |
| Maximum Plasma Concentration (Cmax) of Tilsotolimod | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) | Maximum Observed Plasma Concentration (Cmax) of Tilsotolimod |
| Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) | Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod |
| Area Under Plasma Concentration-Time Curve of Tilsotolimod From Time 0 to the Time of Last Measurable Concentration (AUCt) | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) | Area Under Plasma Concentration-Time Curve of Tilsotolimod From Time 0 to the Time of Last Measurable Concentration (AUCt) |
| Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) | Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Benefit Rate (CBR) | Up to approximately 2 years following the first dose | CBR is measured as the percentage of participants with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) |
| Time to Response (TTR) | Up to approximately 2 years following the first dose | TTR is the time from date of first study drug exposure to the first instance of a complete response (CR) or partial response (PR) as a confirmed response, whichever occurs first. |
| Progression Free Survival (PFS) | Up to approximately 2 years following the first dose | PFS is the time from date of first study drug exposure to disease progression or death, whichever occurs first. |
| Duration of Response (DOR) | Up to approximately 2 years following the first dose | DOR is the time from the participant's initial response (CR or PR as a confirmed response) to disease progression or death, whichever occurs first. |
| Objective Response Rate (ORR) | Up to approximately 2 years following the first dose | ORR is measured as the percentage of participants with a complete response (CR) or partial response (PR) as a confirmed response. |
Countries
France, Germany, Israel, Netherlands, Spain, United States
Outcome results
None listed