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Completed

NCT Number: NCT04196283

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

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).

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Key information

Conditions

Advanced Solid Tumors Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre Antoine Lacassagne - Nice /ID# 215706, Nice, Alpes-Maritimes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ABBV-368

Drug

Intravenous (IV) infusion

Tilsotolimod

Drug

Intratumoral (IT) injection

Nab-paclitaxel

Drug

Intravenous (IV) infusion

ABBV-181

Drug

Intravenous (IV) infusion

Other names: Budigalimab

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to approximately 2 years following the first dose

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.

  2. Change in Vital Signs

    Time frame: Up to approximately 2 years following the first dose

    Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.

  3. Change in Clinical Laboratory Test Results

    Time frame: Up to approximately 2 years following the first dose

    Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.

  4. Maximum Observed Serum Concentration (Cmax) of ABBV-368

    Time frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

    Maximum Serum Concentration (Cmax) of ABBV-368

  5. Time to Maximum Serum Concentration (Tmax) of ABBV-368

    Time frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

    Time to Maximum Serum Concentration (Tmax) of ABBV-368

  6. Area Under Serum Concentration-Time Curve of ABBV-368 From Time 0 to the Time of Last Measurable Concentration (AUCt)

    Time frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

    Area Under Serum Concentration-Time Curve of ABBV-368 From Time 0 to the Time of Last Measurable Concentration (AUCt)

  7. Terminal-Phase Elimination Rate Constant (β) of ABBV-368

    Time frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

    Terminal-Phase Elimination Rate Constant (β) of ABBV-368

  8. Terminal Half-Life (t1/2) of ABBV-368

    Time frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

    Terminal Half-Life (t1/2) of ABBV-368

  9. Maximum Plasma Concentration (Cmax) of Tilsotolimod

    Time frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

    Maximum Observed Plasma Concentration (Cmax) of Tilsotolimod

  10. Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod

    Time frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

    Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod

  11. Area Under Plasma Concentration-Time Curve of Tilsotolimod From Time 0 to the Time of Last Measurable Concentration (AUCt)

    Time frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

    Area Under Plasma Concentration-Time Curve of Tilsotolimod From Time 0 to the Time of Last Measurable Concentration (AUCt)

  12. Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod

    Time frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

    Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod

  13. Terminal Half-Life (t1/2) of Tilsotolimod

    Time frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

    Terminal Half-Life (t1/2) of Tilsotolimod

  14. Maximum Observed Serum Concentration (Cmax) of ABBV-181 (Arm 3 Only)

    Time frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

    Maximum Observed Serum Concentration (Cmax) of ABBV-181

  15. Time to Maximum Serum Concentration (Tmax) of ABBV-181 (Arm 3 Only)

    Time frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

    Time to Maximum Serum Concentration (Tmax) of ABBV-181

  16. Area Under Serum Concentration-Time Curve of ABBV-181 From Time 0 to the Time of Last Measurable Concentration (AUCt) (Arm 3 Only)

    Time frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

    Area Under Serum Concentration-Time Curve of ABBV-181 From Time 0 to the Time of Last Measurable Concentration (AUCt)

  17. Terminal-Phase Elimination Rate Constant (β) of ABBV-181 (Arm 3 Only)

    Time frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

    Terminal-Phase Elimination Rate Constant (β) of ABBV-181

  18. Terminal Half-Life (t1/2) of ABBV-181 (Arm 3 Only)

    Time frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

    Terminal Half-Life (t1/2) of ABBV-181

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to approximately 2 years following the first dose

    ORR is measured as the percentage of participants with a complete response (CR) or partial response (PR) as a confirmed response.

  2. Clinical Benefit Rate (CBR)

    Time frame: Up to approximately 2 years following the first dose

    CBR is measured as the percentage of participants with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD)

  3. Time to Response (TTR)

    Time frame: Up to approximately 2 years following the first dose

    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.

  4. Progression Free Survival (PFS)

    Time frame: Up to approximately 2 years following the first dose

    PFS is the time from date of first study drug exposure to disease progression or death, whichever occurs first.

  5. Duration of Response (DOR)

    Time frame: Up to approximately 2 years following the first dose

    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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Collaborators

  • Idera Pharmaceuticals, Inc.

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 12, 2019
Registry last updated
Feb 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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