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
Contact Information
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).
- 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).
- Solid Tumors