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

Phase 1CompletedNCT04196283

AbbVie30 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumors Cancer

Interventions

ABBV-368DRUG

Intravenous (IV) infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (26)

The University of Chicago Medical Center /ID# 217196

Chicago, Illinois, United States

Norton Cancer Institute /ID# 216179

Louisville, Kentucky, United States

Barbara Ann Karmanos Cancer In /ID# 214050

Detroit, Michigan, United States

Nebraska Methodist Hospital /ID# 215786

Omaha, Nebraska, United States

Atlantic Health System /ID# 216159

Morristown, New Jersey, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Up to approximately 2 years following the first dose

Maximum Observed Serum Concentration (Cmax) of ABBV-368

Maximum Serum Concentration (Cmax) of ABBV-368