Clinical Trials /

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

NCT04196283

Description:

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).

Related Conditions:
  • Hypopharyngeal Squamous Cell Carcinoma
  • Laryngeal Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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
  • 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

Clinical Trial IDs

  • ORG STUDY ID: M19-894
  • SECONDARY ID: 2019-003167-22
  • NCT ID: NCT04196283

Conditions

  • Advanced Solid Tumors Cancer

Interventions

DrugSynonymsArms
ABBV-368Arm 1: ABBV-368 + Tilsotolimod
TilsotolimodArm 1: ABBV-368 + Tilsotolimod
Nab-paclitaxelArm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxel
ABBV-181Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Arm 1: ABBV-368 + TilsotolimodExperimentalParticipants will be administered ABBV-368 and Tilsotolimod at various timepoints as described in the protocol.
  • ABBV-368
  • Tilsotolimod
Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxelExperimentalParticipants will be administered ABBV-368, Tilsotolimod and Nab-paclitaxel at various timepoints as described in the protocol.
  • ABBV-368
  • Tilsotolimod
  • Nab-paclitaxel
Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181ExperimentalParticipants will be administered ABBV-368, Tilsotolimod, Nab-paclitaxel and ABBV-181 at various timepoints as described in the protocol.
  • ABBV-368
  • Tilsotolimod
  • Nab-paclitaxel
  • ABBV-181

Eligibility Criteria

        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 (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.

        Exclusion Criteria:

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Observed Serum Concentration (Cmax) of ABBV-368
Time Frame:Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Safety Issue:
Description:Maximum Serum Concentration (Cmax) of ABBV-368

Secondary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Up to approximately 2 years following the first dose
Safety Issue:
Description:ORR is measured as the percentage of participants with a complete response (CR) or partial response (PR) as a confirmed response.
Measure:Clinical Benefit Rate (CBR)
Time Frame:Up to approximately 2 years following the first dose
Safety Issue:
Description:CBR is measured as the percentage of participants with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD)
Measure:Time to Response (TTR)
Time Frame:Up to approximately 2 years following the first dose
Safety Issue:
Description:TTR is the time from date of first study drug exposure to the first instance of a complete response (CR) or partial response (PR) as a confirmed response, whichever occurs first.
Measure:Progression Free Survival (PFS)
Time Frame:Up to approximately 2 years following the first dose
Safety Issue:
Description:PFS is the time from date of first study drug exposure to disease progression or death, whichever occurs first.
Measure:Duration of Response (DOR)
Time Frame:Up to approximately 2 years following the first dose
Safety Issue:
Description:DOR is the time from the participant's initial response (CR or PR as a confirmed response) to disease progression or death, whichever occurs first.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • 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

Last Updated

December 10, 2019