Phase 1 First in Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-400 in Adult Subjects With Advanced Solid Tumors
- Study HIC#:2000033659
- Last Updated:02/27/2024
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 300 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 85-95 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 gastroesophageal junction adenocarcinoma (GEA) [Part 3] will receive intravenous (IV) ABBV-400 monotherapy, and participants without biomarker selected colorectal cancer (CRC) will receive intravenous (IV) ABBV-400 monotherapy in expansion [Part 4].
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.
Contact Us
For more information about this study, including how to volunteer, contact:
Ingrid Palma
- Phone Number: 1-203-785-6431
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You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
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 (OE) non-squamous wtEGFR or mutEGFR or history of advanced c-Met OE 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 OE 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. Participants must have progressed on
- If applicable, an immune checkpoint inhibitor.
- If applicable, appropriate available therapies, including HER2-directed therapies.
- For Part 4 only - Participants with history of advanced histopathologically or cytologically confirmed colorectal cancer (CRC) that does not harbor the BRAF V600E mutation and are not dMMR+/MSI-Hi with progression on:
- A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine).
- Oxaliplatin.
- Irinotecan.
- If applicable, anti-EGFR (including, but not limited to cetuximab or panitumumab).
- If applicable, anti-vascular endothelial growth factor (VEGF) monoclonal antibody (including but not limited to bevacizumab, ramucirumab, or aflibercept).
- If applicable, targeted therapy
- Participants who are considered ineligible for or are intolerant of standard therapy per investigator are eligible. Prior treatment with Lonsurf or Regorafenib is also acceptable.
- 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.
