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

  • Interventional
  • Recruiting
  • NCT04196283
Eligibility Details Visit Clinicaltrials.gov

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

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).

Gender
All

Age Group
18 Years and up

Accepting 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).

At a Glance

National Government IDNCT04196283

IRB#IRB20-0081

Lead SponsorAbbVie

Lead PhysicianAri Joseph Rosenberg

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting