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)
A Phase 1 First In Human Study Evaluating Safety And Efficacy Of ABBV-637 As Either Monotherapy Or In Combination In Adult Subjects With Relapsed And Refractory Solid Tumors
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Dana-Farber Cancer Institute /ID# 231209 — Boston, Massachusetts
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (33 Sites)
Showing the first 25 of 33 sites.
- Dana-Farber Cancer Institute /ID# 231209 — Boston, Massachusetts
- Washington University-School of Medicine /ID# 225698 — St Louis, Missouri
- Carolina BioOncology Institute /ID# 225358 — Huntersville, North Carolina
- Lifespan Cancer Institute at Rhode Island Hospital /ID# 226145 — Providence, Rhode Island
- South Texas Accelerated Research Therapeutics /ID# 225359 — San Antonio, Texas
- Virginia Cancer Specialists - Fairfax /ID# 225693 — Fairfax, Virginia
- Wollongong Hospital /ID# 228350 — Wollongong, New South Wales
- Austin Health /ID# 225638 — Heidelberg, Victoria
- AP-HM - Hopital de la Timone /ID# 225779 — Marseille, Bouches-du-Rhone
- Institut Bergonie /ID# 225778 — Bordeaux, Gironde
- Institut Curie /ID# 225829 — Paris, Paris
- Centre Georges François Leclerc /ID# 226760 — Dijon,
- Institut Claudius Regaud /ID# 225780 — Toulouse,
- Rambam Health Care Campus /ID# 225586 — Haifa, H_efa
- The Chaim Sheba Medical Center /ID# 225585 — Ramat Gan, Tel Aviv
- NHO Nagoya Medical Center /ID# 244412 — Nagoya, Aichi-ken
- National Cancer Center Hospital East /ID# 225725 — Kashiwa-shi, Chiba
- Duplicate_National Hospital Organization Shikoku Cancer Center /ID# 240821 — Matsuyama, Ehime
- National Hospital Organization Kyushu Cancer Center /ID# 240761 — Fukuoka, Fukuoka
- National Cancer Center Hospital /ID# 225724 — Chuo-ku, Tokyo
- National Cancer Center /ID# 231887 — Goyang-si, Gyeonggido
- Asan Medical Center /ID# 231886 — Seoul, Seoul Teugbyeolsi
- Samsung Medical Center /ID# 231888 — Seoul, Seoul Teugbyeolsi
- Yonsei University Health System Severance Hospital /ID# 233774 — Seoul,
- Hospital Universitario Vall d'Hebron /ID# 225976 — Barcelona, Barcelona
📞 Contact the Study Coordinator
Phone: (877) 338-7425
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.