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Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer Receiving Intravenous (IV) ABBV-400

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05029882
Recruitment Status : Not yet recruiting
First Posted : September 1, 2021
Last Update Posted : September 1, 2021
Information provided by (Responsible Party):

Brief Summary:

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer and is associated with poor prognosis and limited treatment options. 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 NSCLC. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose. Approximately 100 adult participants with NSCLC, or advanced solid tumors, will be enrolled in the study in approximately 7-10 sites in the Dose Escalation phase and 80-85 sites in the Dose Expansion phase worldwide.

In the Dose Escalation arms, participants will receive intravenous (IV) escalating doses of ABBV-400 monotherapy. In the Dose Expansion arms, participants with wtEGFR NSCLC or with mutEGFR NSCLC will receive intravenous (IV) ABBV-400 monotherapy.

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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: ABBV-400 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 First in Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-400 in Adult Subjects With Advanced Solid Tumors
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : June 28, 2025
Estimated Study Completion Date : June 28, 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Part 1 (Monotherapy Dose Escalation)
Participants with advanced solid tumors will receive escalating doses of ABBV-400.
Drug: ABBV-400
Intravenous (IV) Infusion

Experimental: Part 2a (wtEGFR NSCLC)
Participants with c-Met overexpressing advanced non-squamous wtEGFR NSCLC will receive ABBV-400 at the Recommended Phase 2 dose (RP2D).
Drug: ABBV-400
Intravenous (IV) Infusion

Experimental: Part 2b (mutEGFR NSCLC)
Participants with non-squamous mutEGFR NSCLC will receive ABBV-400 at the RP2D.
Drug: ABBV-400
Intravenous (IV) Infusion

Primary Outcome Measures :
  1. Change it to Objective Response Rate (ORR) [ Time Frame: Up to Month 24 ]
    ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Secondary Outcome Measures :
  1. Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1 [ Time Frame: Up to 24 Months ]
    DOR is defined for participants achieving a confirmed CR+PR as the time from the initial response of CR+PR per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier.

  2. PFS per RECIST v1.1 [ Time Frame: Up to 24 Months ]
    Progression-free survival (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.

  3. Overall survival (OS) [ Time Frame: Up to 24 Months ]
    Overall survival (OS) is defined as time from first study treatment to death due to any cause.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologic malignant solid tumor diagnosis (World Health Organization [WHO] criteria).
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • For Part 1 only - history of advanced solid tumor that has progressed on all standard of care therapy and are not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
  • For Part 2 only - history of advanced non-squamous wtEGFR or mutEGFR Non-Small Cell Lung Cancer (NSCLC) and are c-Met positive that has progressed after treatment per the protocol.
  • Should have no more than 2 lines of prior cytotoxic chemotherapy excluding adjuvant therapy and must have advanced NSCLC that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Laboratory values meeting the criteria outlined in the protocol.

Exclusion Criteria:

  • History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.

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 identifier (NCT number): NCT05029882

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Contact: ABBVIE CALL CENTER 844-663-3742

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United States, Colorado
Univ of Colorado Cancer Center /ID# 231574
Aurora, Colorado, United States, 80045
United States, North Carolina
Carolina BioOncology Institute /ID# 231541
Huntersville, North Carolina, United States, 28078
United States, Virginia
Virginia Cancer Specialists - Fairfax /ID# 231575
Fairfax, Virginia, United States, 22031
National Cancer Center Hospital East /ID# 232008
Kashiwa-shi, Chiba, Japan, 277-8577
National Cancer Center Hospital /ID# 232007
Chuo-ku, Tokyo, Japan, 104-0045
Puerto Rico
Pan American Center for Oncology Trials, LLC /ID# 231580
Rio Piedras, Puerto Rico, 00935
Sponsors and Collaborators
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Study Director: ABBVIE INC. AbbVie
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Responsible Party: AbbVie Identifier: NCT05029882    
Other Study ID Numbers: M21-404
2021-002258-98 ( EudraCT Number )
First Posted: September 1, 2021    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
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:
Non-Small Cell Lung Cancer
Advanced Solid Tumors
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms