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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04196283
Recruitment Status : Completed
First Posted : December 12, 2019
Last Update Posted : February 27, 2023
Sponsor:
Collaborator:
Idera Pharmaceuticals, Inc.
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Cancer Drug: ABBV-368 Drug: Tilsotolimod Drug: Nab-paclitaxel Drug: ABBV-181 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 22, 2020
Actual Primary Completion Date : October 27, 2022
Actual Study Completion Date : October 27, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1: ABBV-368 + Tilsotolimod
Participants will be administered ABBV-368 and Tilsotolimod at various timepoints as described in the protocol.
 Drug: ABBV-368
Intravenous (IV) infusion

Drug: Tilsotolimod
Intratumoral (IT) injection
Experimental: Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxel
Participants will be administered ABBV-368, Tilsotolimod and Nab-paclitaxel at various timepoints as described in the protocol.
 Drug: ABBV-368
Intravenous (IV) infusion

Drug: Tilsotolimod
Intratumoral (IT) injection

Drug: Nab-paclitaxel
Intravenous (IV) infusion
Experimental: Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181
Participants will be administered ABBV-368, Tilsotolimod, Nab-paclitaxel and ABBV-181 at various timepoints as described in the protocol.
 Drug: ABBV-368
Intravenous (IV) infusion

Drug: Tilsotolimod
Intratumoral (IT) injection

Drug: Nab-paclitaxel
Intravenous (IV) infusion

Drug: ABBV-181
Intravenous (IV) infusion
Other Name: Budigalimab


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04196283


Locations
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Sponsors and Collaborators
AbbVie
Idera Pharmaceuticals, Inc.
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04196283    
Other Study ID Numbers: M19-894
2019-003167-22 ( EudraCT Number )
First Posted: December 12, 2019    Key Record Dates
Last Update Posted: February 27, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
 Neoplasms by Site
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action