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

AbbVie

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors Cancer

Treatments: Drug: ABBV-368; Drug: ABBV-181; Drug: Nab-paclitaxel; Drug: Tilsotolimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT04196283

M19-894

2019-003167-22 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Arm 1: ABBV-368 + Tilsotolimod

Experimental group

Description:

Participants will be administered ABBV-368 and Tilsotolimod at various timepoints as described in the protocol.

Treatment:

Drug: ABBV-368

Drug: Tilsotolimod

Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxel

Experimental group

Description:

Participants will be administered ABBV-368, Tilsotolimod and Nab-paclitaxel at various timepoints as described in the protocol.

Treatment:

Drug: ABBV-368

Drug: Tilsotolimod

Drug: Nab-paclitaxel

Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181

Experimental group

Description:

Participants will be administered ABBV-368, Tilsotolimod, Nab-paclitaxel and ABBV-181 at various timepoints as described in the protocol.

Treatment:

Drug: ABBV-368

Drug: Tilsotolimod

Drug: ABBV-181

Drug: Nab-paclitaxel