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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
NCT04721015 · View on ClinicalTrials.gov ↗
Study 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 of the lung. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of ABBV-637 alone or in combination with docetaxel/osimertinib in participants with solid tumors (NSCLC). Adverse events and change in disease activity will be assessed. ABBV-637 is an investigational drug being developed for the treatment of solid tumors. Study consists of 3 parts - monotherapy dose escalation (Part 1), combination dose escalation and expansion (Parts 2a and 2b) with docetaxel and combination dose escalation and expansion (Parts 3a and 3b) with osimertinib. Approximately 109 adult participants with relapsed/refractory (R/R) solid tumors will be enrolled in approximately 30 sites across the world. In Part 1, participants with solid tumors will receive intravenous (IV) ABBV-637 in 28-day cycles. In Part 2a and 2b, participants will receive IV ABBV-637 in combination with IV docetaxel in 28-day cycles. In Part 3a and 3b, participants will receive intravenous (IV) ABBV-637 in combination with daily oral tablets of osimertinib in 28-day cycle. 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 a hospital or clinic. Treatment effects will be monitored by medical assessments, blood tests, side effect reporting, and questionnaires.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Osimertinib
- DRUG ABBV-637
Study Locations (20)
Other
- Centre Georges François Leclerc /ID# 226760 — Dijon
- Institut Claudius Regaud /ID# 225780 — Toulouse
Massachusetts
- Dana-Farber Cancer Institute /ID# 231209 — Boston
Missouri
- Washington University-School of Medicine /ID# 225698 — St Louis
North Carolina
- Carolina BioOncology Institute /ID# 225358 — Huntersville
Rhode Island
- Lifespan Cancer Institute at Rhode Island Hospital /ID# 226145 — Providence
Texas
- South Texas Accelerated Research Therapeutics /ID# 225359 — San Antonio
Virginia
- Virginia Cancer Specialists - Fairfax /ID# 225693 — Fairfax
New South Wales
- Wollongong Hospital /ID# 228350 — Wollongong
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2021-02-23 |
| Est. Completion | 2026-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04721015
The ClinicalTrials.gov registry entry for NCT04721015 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Advanced Solid Tumors Cancer appearing as the primary indexed condition, and to 3 interventions — of which Docetaxel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04721015 reports 20 study locations spanning 19 distinct geographic areas — top geographies include Other, Massachusetts, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04721015 about?
NCT04721015 is a clinical study titled "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". 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 of the lung. The purpose of this study is to evaluate the safety and efficacy (how well the study d...
What is the current status of trial NCT04721015?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2021-02-23. Estimated completion is 2026-02.
What conditions does trial NCT04721015 study?
This clinical trial studies the following conditions: Advanced Solid Tumors Cancer, Non Small Cell Lung Cancer (NSCLC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04721015?
The interventions under investigation include: Docetaxel (DRUG), Osimertinib (DRUG), ABBV-637 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04721015?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04721015 being conducted?
This trial has 20 study locations across Massachusetts, Missouri, North Carolina, Rhode Island, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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