Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABBV-181 | Drug | — | UNRESOLVED |
| ABBV-368 | Drug | — | UNRESOLVED |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Tilsotolimod | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1: ABBV-368 + Tilsotolimod
- description
- Participants will be administered ABBV-368 and Tilsotolimod at various timepoints as described in the protocol.
- interventionNames
- Drug: ABBV-368
- Drug: Tilsotolimod
- type
- EXPERIMENTAL
- label
- Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxel
- description
- Participants will be administered ABBV-368, Tilsotolimod and Nab-paclitaxel at various timepoints as described in the protocol.
- interventionNames
- Drug: ABBV-368
- Drug: Tilsotolimod
- Drug: Nab-paclitaxel
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (1)
- DERIVEDDaste 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. PMID 41956545