Lung Cancer Clinical Trial
Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400
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 220 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.
Eligibility Criteria
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.
For Part 3 only - history of advanced histopathologically or cytologically confirmed diagnosis of c-Met overexpressing GEA that has progressed after treatment with at least 1 prior cytotoxic chemotherapeutic regimen for locally advanced or metastatic disease and have not received more than 2 prior lines of cytotoxic chemotherapy regimens. If applicable, participants must have progressed on an immune checkpoint inhibitor or appropriate available therapies.
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.
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There are 12 Locations for this study
Aurora Colorado, 80045, United States
Grand Rapids Michigan, 49546, United States
Las Vegas Nevada, 89119, United States
Huntersville North Carolina, 28078, United States
San Antonio Texas, 78229, United States
Fairfax Virginia, 22031, United States
Ramat Gan Tel-Aviv, 52656, Israel
Jerusalem Yerushalayim, 91120, Israel
Haifa , 31096, Israel
Kashiwa-shi Chiba, 277-8, Japan
Chuo-ku Tokyo, 104-0, Japan
Rio Piedras , 00935, Puerto Rico
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