Status:
ACTIVE_NOT_RECRUITING
Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors
Lead Sponsor:
AbbVie
Conditions:
Advanced Solid Tumors Cancer
Non Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues...
Eligibility Criteria
Inclusion
- Histologic solid tumor diagnosis (Part 1).
- For Part 2 docetaxel combination therapy: EGFR WT expressing relapsed/refractory (R/R) non-small cell lung cancer (NSCLC) participants.
- For Part 3 osimertinib combination therapy: mutEGFR-expressing RR NSCLC participants.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- For Part 1 only - history of R/R disease that has progressed on all standard of care therapy.
- For Part 2 only - history of RR NSCLC that has progressed after treatment with platinum-based chemotherapy regimen and either immune checkpoint inhibitor or targeted therapy and may not have been treated with prior single agent chemotherapy.
- For Part 3 only - history of RR NSCLC that has progressed on osimertinib
- Meet the laboratory values as described in the protocol.
Exclusion
- History (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, cardiac arrhythmia requiring pharmacological or surgical intervention, pericardial effusion, or pericarditis.
- Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
- For Part 3 only: History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis.
Key Trial Info
Start Date :
February 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT04721015
Start Date
February 23 2021
End Date
February 1 2026
Last Update
July 3 2025
Active Locations (33)
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1
Dana-Farber Cancer Institute /ID# 231209
Boston, Massachusetts, United States, 02215
2
Washington University-School of Medicine /ID# 225698
St Louis, Missouri, United States, 63110
3
Carolina BioOncology Institute /ID# 225358
Huntersville, North Carolina, United States, 28078
4
Lifespan Cancer Institute at Rhode Island Hospital /ID# 226145
Providence, Rhode Island, United States, 02903-4923