Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003167-22 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Idera Pharmaceuticals, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-368 | Drug | Intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | 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. | Up to approximately 2 years following the first dose |
| Change in Vital Signs | Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported. | Up to approximately 2 years following the first dose |
| Change in Clinical Laboratory Test Results | Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported. | Up to approximately 2 years following the first dose |
| Maximum Observed Serum Concentration (Cmax) of ABBV-368 | Maximum Serum Concentration (Cmax) of ABBV-368 | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) |
| Time to Maximum Serum Concentration (Tmax) of ABBV-368 | Time to Maximum Serum Concentration (Tmax) of ABBV-368 | 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) | Area Under Serum Concentration-Time Curve of ABBV-368 From Time 0 to the Time of Last Measurable Concentration (AUCt) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is measured as the percentage of participants with a complete response (CR) or partial response (PR) as a confirmed response. | Up to approximately 2 years following the first dose |
| Clinical Benefit Rate (CBR) |
Not provided
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.
Exclusion Criteria:
Uncontrolled metastases to the central nervous system (CNS).
Received prior treatment with OX40 or toll-like receptor (TLR) agonists (excluding topical agents).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago Medical Center /ID# 217196 | Chicago | Illinois | 60637-1443 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41956545 | Derived | Daste A, Le X, Makkouk A, Patel M, Le Tourneau C, Perets R, Popovtzer A, Ochsenreither S, Haderlein M, Oliva M, Sukari A, Hong J, Blaney M, Ramathal C, McDevitt M, Rosenberg AJ. Phase 1b study of ABBV-368, tilsotolimod, budigalimab, and nab-paclitaxel in patients with recurrent/metastatic head and neck squamous cell carcinoma. J Immunother Cancer. 2026 Apr 9;14(4):e014086. doi: 10.1136/jitc-2025-014086. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tilsotolimod | Drug | Intratumoral (IT) injection |
|
| Nab-paclitaxel | Drug | Intravenous (IV) infusion |
|
| ABBV-181 | Drug | Intravenous (IV) infusion |
|
|
| Cycle 1 through Cycle 3 (each cycle is approximately 28 days) |
| Terminal-Phase Elimination Rate Constant (β) of ABBV-368 | Terminal-Phase Elimination Rate Constant (β) of ABBV-368 | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) |
| Terminal Half-Life (t1/2) of ABBV-368 | Terminal Half-Life (t1/2) of ABBV-368 | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) |
| Maximum Plasma Concentration (Cmax) of Tilsotolimod | Maximum Observed Plasma Concentration (Cmax) of Tilsotolimod | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) |
| Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod | Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod | 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) | 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) |
| Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod | Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) |
| Terminal Half-Life (t1/2) of Tilsotolimod | Terminal Half-Life (t1/2) of Tilsotolimod | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) |
| Maximum Observed Serum Concentration (Cmax) of ABBV-181 (Arm 3 Only) | Maximum Observed Serum Concentration (Cmax) of ABBV-181 | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) |
| Time to Maximum Serum Concentration (Tmax) of ABBV-181 (Arm 3 Only) | Time to Maximum Serum Concentration (Tmax) of ABBV-181 | 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) (Arm 3 Only) | Area Under Serum Concentration-Time Curve of ABBV-181 From Time 0 to the Time of Last Measurable Concentration (AUCt) | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) |
| Terminal-Phase Elimination Rate Constant (β) of ABBV-181 (Arm 3 Only) | Terminal-Phase Elimination Rate Constant (β) of ABBV-181 | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) |
| Terminal Half-Life (t1/2) of ABBV-181 (Arm 3 Only) | Terminal Half-Life (t1/2) of ABBV-181 | Cycle 1 through Cycle 3 (each cycle is approximately 28 days) |
CBR is measured as the percentage of participants with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD)
| Up to approximately 2 years following the first dose |
| Time to Response (TTR) | 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. | Up to approximately 2 years following the first dose |
| Progression Free Survival (PFS) | PFS is the time from date of first study drug exposure to disease progression or death, whichever occurs first. | Up to approximately 2 years following the first dose |
| Duration of Response (DOR) | 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. | Up to approximately 2 years following the first dose |
| Norton Cancer Institute /ID# 216179 |
| Louisville |
| Kentucky |
| 40241-2832 |
| United States |
| Barbara Ann Karmanos Cancer In /ID# 214050 | Detroit | Michigan | 48201 | United States |
| Nebraska Methodist Hospital /ID# 215786 | Omaha | Nebraska | 68114 | United States |
| Atlantic Health System /ID# 216159 | Morristown | New Jersey | 07960-6136 | United States |
| Roswell Park Comprehensive Cancer Center /ID# 215882 | Buffalo | New York | 14263 | United States |
| Vanderbilt Ingram Cancer Center /ID# 214040 | Nashville | Tennessee | 37232-0021 | United States |
| MD Anderson Cancer Center /ID# 214041 | Houston | Texas | 77030 | United States |
| Centre Antoine Lacassagne - Nice /ID# 215706 | Nice | Alpes-Maritimes | 06189 | France |
| AP-HM - Hopital de la Timone /ID# 215657 | Marseille | Bouches-du-Rhone | 13385 | France |
| Hopital Saint-Andre /ID# 215702 | Bordeaux | Gironde | 33075 | France |
| Institut Curie /ID# 215653 | Paris | Île-de-France Region | 75248 | France |
| Universitaetsklinikum Erlangen /ID# 214196 | Erlangen | Bavaria | 91054 | Germany |
| Universitaetsklinikum Leipzig /ID# 214200 | Leipzig | Saxony | 04103 | Germany |
| Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214197 | Berlin | 12203 | Germany |
| The Chaim Sheba Medical Center /ID# 215229 | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Rambam Health Care Campus /ID# 215231 | Haifa | 3109601 | Israel |
| Gastroenterology Institute, Division of Medicine /ID# 215862 | Jerusalem | 91120 | Israel |
| Antoni van Leeuwenhoek /ID# 215291 | Amsterdam | North Holland | 1066 CX | Netherlands |
| Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 221402 | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Hospital Universitario de Fuenlabrada /ID# 214263 | Fuenlabrada | Madrid | 28942 | Spain |
| Hospital Clinic de Barcelona /ID# 214264 | Barcelona | 08036 | Spain |
| Hospital Universitario 12 de Octubre /ID# 214198 | Madrid | 28041 | Spain |
| Hospital Universitario HM Sanchinarro /ID# 214110 | Madrid | 28050 | Spain |
| Hospital Universitario Virgen de la Victoria /ID# 214109 | Málaga | 29010 | Spain |
| Hospital Clinico Universitario de Valencia /ID# 221401 | Valencia | 46010 | Spain |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C000723013 | tilsotolimod |
| C520255 | 130-nm albumin-bound paclitaxel |
| C000719868 | budigalimab |
Not provided
Not provided
Not provided