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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
Sponsor: AbbVie
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
81
Start Date
2021-02-23
Completion Date
2026-02
Last Updated
2025-07-03
Healthy Volunteers
No
Interventions
ABBV-637
Intravenous (IV) Infusion
Docetaxel
Intravenous (IV) Infusion
Osimertinib
Oral Tablets
Locations (33)
Dana-Farber Cancer Institute /ID# 231209
Boston, Massachusetts, United States
Washington University-School of Medicine /ID# 225698
St Louis, Missouri, United States
Carolina BioOncology Institute /ID# 225358
Huntersville, North Carolina, United States
Lifespan Cancer Institute at Rhode Island Hospital /ID# 226145
Providence, Rhode Island, United States
South Texas Accelerated Research Therapeutics /ID# 225359
San Antonio, Texas, United States
Virginia Cancer Specialists - Fairfax /ID# 225693
Fairfax, Virginia, United States
Wollongong Hospital /ID# 228350
Wollongong, New South Wales, Australia
Austin Health /ID# 225638
Heidelberg, Victoria, Australia
AP-HM - Hopital de la Timone /ID# 225779
Marseille, Bouches-du-Rhone, France
Institut Bergonie /ID# 225778
Bordeaux, Gironde, France
Institut Curie /ID# 225829
Paris, Paris, France
Centre Georges François Leclerc /ID# 226760
Dijon, France
Institut Claudius Regaud /ID# 225780
Toulouse, France
Rambam Health Care Campus /ID# 225586
Haifa, H_efa, Israel
The Chaim Sheba Medical Center /ID# 225585
Ramat Gan, Tel Aviv, Israel
NHO Nagoya Medical Center /ID# 244412
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East /ID# 225725
Kashiwa-shi, Chiba, Japan
Duplicate_National Hospital Organization Shikoku Cancer Center /ID# 240821
Matsuyama, Ehime, Japan
National Hospital Organization Kyushu Cancer Center /ID# 240761
Fukuoka, Fukuoka, Japan
National Cancer Center Hospital /ID# 225724
Chuo-ku, Tokyo, Japan
National Cancer Center /ID# 231887
Goyang-si, Gyeonggido, South Korea
Asan Medical Center /ID# 231886
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 231888
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 233774
Seoul, South Korea
Hospital Universitario Vall d'Hebron /ID# 225976
Barcelona, Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 225975
Madrid, Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 225977
Madrid, Madrid, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 226096
Majadahonda, Madrid, Spain
Hospital Universitario Virgen de la Victoria /ID# 225978
Málaga, Malaga, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 243345
Kaohsiung City, Kaohsiung, Taiwan
National Cheng Kung University Hospital /ID# 225944
Tainan, Tainan, Taiwan
National Taiwan University Hospital - Hsinchu branch /ID# 243610
Hsinchu, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 225946
Taoyuan, Taiwan