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Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400

Primary Purpose

Hepatocellular Carcinoma, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancers

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ABBV-400
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancers, Esophageal Squamous Cell Carcinoma, Triple Negative Breast Cancer, Hormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer, Head and Neck Squamous-Cell Carcinoma, Solid Tumors, Advanced Solid Tumors, ABBV-400

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Laboratory values meeting the criteria laid out in the protocol. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Documented diagnosis of locally advanced or metastatic hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), squamous cell carcinoma of the esophagus, (ESCC), triple negative breast cancer (TNBC), hormone receptor+/HER2-breast cancer (HR+/HER2-BC), or head and neck squamous-cell-carcinoma (HNSCC) (by World Health Organization [WHO] criteria). Participant meets the criteria for disease activity laid out in the protocol. Any autoimmune, connective tissue or inflammatory disorders with documented or suspicious pulmonary involvement at screening (i.e., rheumatoid arthritis, Sjogren's, sarcoidosis etc.), and prior pneumonectomy. Exclusion Criteria: Have received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400. Palliative radiation therapy for bone, skin, or subcutaneous metastases with 10 fractions or less is permitted and not subject to a washout period. Unresolved AEs > Grade 1 from prior anticancer therapy except for alopecia. History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis, including but not limited to those listed in the protocol. History of clinically significant, intercurrent lung-specific illnesses, including those laid out in the protocol. Untreated brain or meningeal metastases (i.e., participants with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic stability for at least 14 days after definitive therapy). Participants may continue on antiepileptic therapy if required. History of other active malignancy, with the exception of those laid out in the protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Cohort 1: Hepatocellular Carcinoma (HCC)

    Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC)

    Cohort 3: Biliary Tract Cancers (BTC)

    Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC)

    Cohort 5: Triple Negative Breast Cancer (TNBC)

    Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC)

    Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC)

    Arm Description

    Participants with HCC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

    Participants with PDAC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

    Participants with BTC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

    Participants with ESCC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

    Participants with TNBC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

    Participants with HR+/HER2-BC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

    Participants with HNSCC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

    Outcomes

    Primary Outcome Measures

    Objective Response Rate (ORR)
    ORR defined as percentage of participants with confirmed best overall response of confirmed partial response (PR) or better per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Secondary Outcome Measures

    Duration of Response (DOR) for Participants with Confirmed Complete Response (CR)/PR
    DOR is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier.
    Clinical Benefit Rate
    CBR is defined as the proportion of participants with a best overall response of stable disease at least 5 weeks post first dose, confirmed CR or PR per investigator review according to RECIST, version 1.1
    Progression-free Survival (PFS)
    PFS is defined as time from first study treatment to a documented disease progression according to RECIST, version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.
    Overall Survival (OS)
    OS is defined as time from first study treatment to death due to any cause.
    Maximum Observed Concentration (Cmax) of ABBV-400
    Cmax of ABBV-400.
    Time to Cmax (Tmax) of ABBV-400
    Tmax of ABBV-400.
    Area Under the Plasma Concentration-time Curve (AUC) for Total Antibody Concentration
    AUC for total antibody concentration.
    Total Antibody Drug Conjugate (ADC) Concentration
    Total ADC concentration.
    Plasma Concentrations of Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload
    Plasma concentrations of unconjugated Top1 inhibitor payload.
    Antidrug Antibody (ADA)
    Incidence and concentration of anti-drug antibodies.
    Neutralizing Antidrug Antibody (nADA)
    Incidence and concentration of neutralizing anti-drug antibodies.

    Full Information

    First Posted
    October 10, 2023
    Last Updated
    October 10, 2023
    Sponsor
    AbbVie
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06084481
    Brief Title
    Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400
    Official Title
    A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 19, 2023 (Anticipated)
    Primary Completion Date
    July 11, 2026 (Anticipated)
    Study Completion Date
    July 20, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AbbVie

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors. ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called cohorts. Each cohort receives ABBV-400 alone (monotherapy) followed by a safety follow-up period. Approximately 220 adult participants with hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), esophageal squamous cell carcinoma (ESCC), triple negative breast cancer (TNBC), hormone receptor+/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (hormone receptor-positive [HR+]/HER2-breast cancer [BC]), head and neck squamous-cell-carcinoma (HNSCC), or advanced solid tumors, will be enrolled in the study in approximately 60 sites worldwide. In the each cohorts, participants with the following advanced solid tumor indications: HCC, PDAC, BTC, ESCC, TNBC, HR+/HER2-BC, and HNSCC will receive intravenous (IV) ABBV-400 monotherapy for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatocellular Carcinoma, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancers, Esophageal Squamous Cell Carcinoma, Triple Negative Breast Cancer, Hormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer, Head and Neck Squamous-Cell Carcinoma
    Keywords
    Hepatocellular Carcinoma, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancers, Esophageal Squamous Cell Carcinoma, Triple Negative Breast Cancer, Hormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer, Head and Neck Squamous-Cell Carcinoma, Solid Tumors, Advanced Solid Tumors, ABBV-400

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    220 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cohort 1: Hepatocellular Carcinoma (HCC)
    Arm Type
    Experimental
    Arm Description
    Participants with HCC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
    Arm Title
    Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC)
    Arm Type
    Experimental
    Arm Description
    Participants with PDAC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
    Arm Title
    Cohort 3: Biliary Tract Cancers (BTC)
    Arm Type
    Experimental
    Arm Description
    Participants with BTC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
    Arm Title
    Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC)
    Arm Type
    Experimental
    Arm Description
    Participants with ESCC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
    Arm Title
    Cohort 5: Triple Negative Breast Cancer (TNBC)
    Arm Type
    Experimental
    Arm Description
    Participants with TNBC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
    Arm Title
    Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC)
    Arm Type
    Experimental
    Arm Description
    Participants with HR+/HER2-BC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
    Arm Title
    Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC)
    Arm Type
    Experimental
    Arm Description
    Participants with HNSCC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
    Intervention Type
    Drug
    Intervention Name(s)
    ABBV-400
    Intervention Description
    Intravenous (IV) Infusion
    Primary Outcome Measure Information:
    Title
    Objective Response Rate (ORR)
    Description
    ORR defined as percentage of participants with confirmed best overall response of confirmed partial response (PR) or better per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
    Time Frame
    Up to 24 Months
    Secondary Outcome Measure Information:
    Title
    Duration of Response (DOR) for Participants with Confirmed Complete Response (CR)/PR
    Description
    DOR is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier.
    Time Frame
    Up to 24 Months
    Title
    Clinical Benefit Rate
    Description
    CBR is defined as the proportion of participants with a best overall response of stable disease at least 5 weeks post first dose, confirmed CR or PR per investigator review according to RECIST, version 1.1
    Time Frame
    Up to 24 Months
    Title
    Progression-free Survival (PFS)
    Description
    PFS is defined as time from first study treatment to a documented disease progression according to RECIST, version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.
    Time Frame
    Up to 24 Months
    Title
    Overall Survival (OS)
    Description
    OS is defined as time from first study treatment to death due to any cause.
    Time Frame
    Up to 24 Months
    Title
    Maximum Observed Concentration (Cmax) of ABBV-400
    Description
    Cmax of ABBV-400.
    Time Frame
    Up to 24 Months
    Title
    Time to Cmax (Tmax) of ABBV-400
    Description
    Tmax of ABBV-400.
    Time Frame
    Up to 24 Months
    Title
    Area Under the Plasma Concentration-time Curve (AUC) for Total Antibody Concentration
    Description
    AUC for total antibody concentration.
    Time Frame
    Up to 24 Months
    Title
    Total Antibody Drug Conjugate (ADC) Concentration
    Description
    Total ADC concentration.
    Time Frame
    Up to 24 Months
    Title
    Plasma Concentrations of Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload
    Description
    Plasma concentrations of unconjugated Top1 inhibitor payload.
    Time Frame
    Up to 24 Months
    Title
    Antidrug Antibody (ADA)
    Description
    Incidence and concentration of anti-drug antibodies.
    Time Frame
    Up to 24 Months
    Title
    Neutralizing Antidrug Antibody (nADA)
    Description
    Incidence and concentration of neutralizing anti-drug antibodies.
    Time Frame
    Up to 24 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Laboratory values meeting the criteria laid out in the protocol. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Documented diagnosis of locally advanced or metastatic hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), squamous cell carcinoma of the esophagus, (ESCC), triple negative breast cancer (TNBC), hormone receptor+/HER2-breast cancer (HR+/HER2-BC), or head and neck squamous-cell-carcinoma (HNSCC) (by World Health Organization [WHO] criteria). Participant meets the criteria for disease activity laid out in the protocol. Any autoimmune, connective tissue or inflammatory disorders with documented or suspicious pulmonary involvement at screening (i.e., rheumatoid arthritis, Sjogren's, sarcoidosis etc.), and prior pneumonectomy. Exclusion Criteria: Have received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400. Palliative radiation therapy for bone, skin, or subcutaneous metastases with 10 fractions or less is permitted and not subject to a washout period. Unresolved AEs > Grade 1 from prior anticancer therapy except for alopecia. History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis, including but not limited to those listed in the protocol. History of clinically significant, intercurrent lung-specific illnesses, including those laid out in the protocol. Untreated brain or meningeal metastases (i.e., participants with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic stability for at least 14 days after definitive therapy). Participants may continue on antiepileptic therapy if required. History of other active malignancy, with the exception of those laid out in the protocol
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ABBVIE CALL CENTER
    Phone
    844-663-3742
    Email
    abbvieclinicaltrials@abbvie.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ABBVIE INC.
    Organizational Affiliation
    AbbVie
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://www.abbvieclinicaltrials.com/study/?id=M24-427
    Description
    Related Info

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