Clinical trial · Interventional
A Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 1b Multi-Center Pharmacodynamic Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced 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
Why stopped (as posted): Strategic considerations
Summary
Brief summary (as posted)
A study evaluating the safety, pharmacokinetics, and biomarker profiles of multiple study drugs as monotherapy in subjects with newly diagnosed, treatment-naïve locally advanced squamous cell carcinoma of the head and neck who are candidates for surgical resection.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABBV-181 | Drug | — | UNRESOLVED |
| ABBV-368 | Drug | — | UNRESOLVED |
| ABBV-927 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm 1: ABBV-181 IV
- description
- A single dose of ABBV-181 administered via intravenous (IV) infusion on Day 1.
- interventionNames
- Drug: ABBV-181
- type
- EXPERIMENTAL
- label
- Arm 2: ABBV-368 IV
- description
- A single dose of ABBV-368 administered via intravenous (IV) infusion on Day 1.
- interventionNames
- Drug: ABBV-368
- type
- EXPERIMENTAL
- label
- Arm 3: ABBV-927 IV
- description
- A single dose of ABBV-927 administered via intravenous (IV) infusion on Day 1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed stage 3 to 4B squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx who are candidates for surgical resection and are treatment-naïve. Participants must have been determined to be candidates for surgical resection by a multidisciplinary team including a surgeon, a medical oncologist, and a radiation oncologist. * Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 and life expectancy of more than 3 months. * Must consent to provide the tumor tissues for analyses as described in the protocol. * Must have adequate bone marrow function (without any growth factors or transfusions within 2 weeks prior to the first dose), kidney and liver function, with all laboratory values criteria detailed in the protocol. Exclusion Criteria: * Has received live vaccine within 28 days prior to the first dose of study drug. * Has a history of inflammatory bowel disease, a history of or ongoing pneumonitis or interstitial lung disease, had major surgery ≤ 28 days prior to the first dose of study drug and the surgical wound is not fully healed. * Participants with hypopharyngeal or laryngeal tumors will not be candidates for Arm 4 of the study (IT injection of ABBV-927). * Requires use of an immunosuppressive medication within 14 days prior to the first dose of the study drug; exceptions are described in the protocol. * Has a confirmed positive test results for human immunodeficiency virus, or have active hepatitis A, B or C. * Has a history of primary immunodeficiency, allogeneic bone marrow transplantation, solid organ transplantation, or previous clinical diagnosis of tuberculosis. * Has a history of any other malignancy within the past 3 years except for successfully treated non-melanoma skin cancer or localized carcinoma in situ that is considered cured or adequately treated by the investigator.
References
Publications (0)
Data not yet available