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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

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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)

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

Trial contacts and locations

26

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Data sourced from clinicaltrials.gov

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