Summary

for people ages 18 years and up (full criteria)
at UCSD
study started
estimated completion

Description

Summary

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).

Official Title

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

Keywords

Advanced Solid Tumors Cancer Squamous Cell Carcinoma Head and Neck Squamous Cell Carcinoma Locally Advanced Head and Neck Squamous Cell Carcinoma Metastatic Head and Neck Squamous Cell Carcinoma Cancer Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Paclitaxel Albumin-Bound Paclitaxel ABBV-368 Tilsotolimod Nab-paclitaxel ABBV-181

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 (IT) 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 <= 2 prior treatment regimens administered in the recurrent or metastatic setting.
  • Must have received 1 immunotherapy regimen which included a PD-(L)1 inhibitor in the recurrent or metastatic setting.

You CAN'T join if...

  • No 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.
  • Must not have received any prior anti-cancer immunotherapy other than a programmed cell death 1 (PD-1) or programmed cell death ligand 1 (PD-L1) inhibitor.

Locations

  • UCSD Moores Cancer Center - LaJolla /ID# 216181 not yet accepting patients
    La Jolla California 92093 United States
  • University of Oklahoma, Stephenson Cancer Center /ID# 215880 not yet accepting patients
    Oklahoma City Oklahoma 73104-5418 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT04196283
Phase
Phase 1
Study Type
Interventional
Last Updated