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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

Sponsor
AbbVie (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04196283
Collaborator
Idera Pharmaceuticals, Inc. (Industry)
30
Enrollment
26
Locations
3
Arms
34.1
Anticipated Duration (Months)
1.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Jan 22, 2020
Anticipated Primary Completion Date :
Nov 25, 2022
Anticipated Study Completion Date :
Nov 25, 2022

Arms and Interventions

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 Names:
  • Budigalimab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Adverse Events (AEs) [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 [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 [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 [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 [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) [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 [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 [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 [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 [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) [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 [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 [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 The University of Chicago Medical Center /ID# 217196 Chicago Illinois United States 60637-1443
    2 Norton Cancer Institute /ID# 216179 Louisville Kentucky United States 40241-2832
    3 Barbara Ann Karmanos Cancer In /ID# 214050 Detroit Michigan United States 48201
    4 Nebraska Methodist Hospital /ID# 215786 Omaha Nebraska United States 68114
    5 Atlantic Health System /ID# 216159 Morristown New Jersey United States 07960-6136
    6 Roswell Park Comprehensive Cancer Center /ID# 215882 Buffalo New York United States 14263
    7 Vanderbilt Ingram Cancer Center /ID# 214040 Nashville Tennessee United States 37232-0021
    8 MD Anderson Cancer Center /ID# 214041 Houston Texas United States 77030
    9 Centre Antoine Lacassagne - Nice /ID# 215706 Nice Alpes-Maritimes France 06189
    10 AP-HM - Hopital de la Timone /ID# 215657 Marseille CEDEX 05 Bouches-du-Rhone France 13385
    11 Institut Curie /ID# 215653 Paris CEDEX 05 Ile-de-France France 75248
    12 Hopital Saint-Andre /ID# 215702 Bordeaux France 33075
    13 Universitaetsklinikum Erlangen /ID# 214196 Erlangen Bayern Germany 91054
    14 Universitaetsklinikum Leipzig /ID# 214200 Leipzig Sachsen Germany 04103
    15 Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214197 Berlin Germany 12203
    16 The Chaim Sheba Medical Center /ID# 215229 Ramat Gan Tel-Aviv Israel 5265601
    17 Rambam Health Care Campus /ID# 215231 Haifa Israel 3109601
    18 Gastroenterology Institute, Division of Medicine /ID# 215862 Jerusalem Israel 91120
    19 Antoni van Leeuwenhoek /ID# 215291 Amsterdam Noord-Holland Netherlands 1066 CX
    20 Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 221402 Hospitalet de Llobregat Barcelona Spain 08908
    21 Hospital Universitario de Fuenlabrada /ID# 214263 Fuenlabrada Madrid Spain 28942
    22 Hospital Clinic de Barcelona /ID# 214264 Barcelona Spain 08036
    23 Hospital Universitario 12 de Octubre /ID# 214198 Madrid Spain 28041
    24 Hospital Universitario HM Sanchinarro /ID# 214110 Madrid Spain 28050
    25 Hospital Universitario Virgen de la Victoria /ID# 214109 Malaga Spain 29010
    26 Hospital Clinico Universitario de Valencia /ID# 221401 Valencia Spain 46010

    Sponsors and Collaborators

    • AbbVie
    • Idera Pharmaceuticals, Inc.

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT04196283
    Other Study ID Numbers:
    • M19-894
    • 2019-003167-22
    First Posted:
    Dec 12, 2019
    Last Update Posted:
    Mar 11, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Carcinoma
    Carcinoma, Squamous Cell
    Squamous Cell Carcinoma of Head and Neck
    Paclitaxel

    Study Results

    No Results Posted as of Mar 11, 2022