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

  • STATUS
    Recruiting
  • End date
    Jun 22, 2025
  • participants needed
    190
  • sponsor
    AbbVie
Updated on 14 July 2022
measurable disease
growth factor
epidermal growth factor receptor
HER2
EGFR
c-MET
cancer chemotherapy
targeted therapy
erbb2
epidermal growth factor
lung carcinoma
squamous non-small cell lung cancer

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 advanced solid tumors. 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 190 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 biomarker-selected dose expansion arms, participants in the following c-Met overexpressing advanced solid tumor indications: c-Met-intermediate/high non-squamous NSCLC with wildtype EGFR-expression (wtEGFR NSCLC) (Part 2a) or mutated EGFR-expression (mutEGFR NSCLC) (Part 2b), c-Met low non-squamous wtEGFR NSCLC (Part 2c), squamous NSCLC (Part 2d), and GEA (Part 3) 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.

Details
Condition Non-Small Cell Lung Cancer, Advanced Solid Tumors, Gastroesophageal Adenocarcinoma
Treatment ABBV-400
Clinical Study IdentifierNCT05029882
SponsorAbbVie
Last Modified on14 July 2022

Eligibility

Yes No Not Sure

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 c-Met overexpressing non-squamous wtEGFR or mutEGFR or history of advanced c-Met overexpressing squamous Non-Small Cell Lung Cancer (NSCLC) that have 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
For Part 3 only - history of advanced histopathologically or cytologically confirmed diagnosis of c-Met overexpressing GEA that has progressed after treatment with at
Laboratory values meeting the criteria outlined in the protocol
least
prior cytotoxic chemotherapeutic regimen for locally advanced or metastatic disease and has not received >= 2 prior lines of cytotoxic chemotherapy regimens in the locally advanced or metastatic setting
If applicable, an immune checkpoint inhibitor
If applicable, human epidermal growth factor receptor 2 (HER2) directed therapy
If applicable, standard of care targeted therapy

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
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