Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
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
Study ID: NCT04721015
Study Description
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 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Dana-Farber Cancer Institute /ID# 231209, Boston, Massachusetts, United States
Washington University-School of Medicine /ID# 225698, Saint 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 CEDEX 05, Bouches-du-Rhone, France
Institut Bergonie /ID# 225778, Bordeaux, Gironde, France
Institut Curie /ID# 225829, Paris CEDEX 05, Ile-de-France, France
Centre Georges François Leclerc /ID# 226760, Dijon, , France
Institut Claudius Regaud /ID# 225780, Toulouse, , France
The Chaim Sheba Medical Center /ID# 225585, Ramat Gan, Tel-Aviv, Israel
Rambam Health Care Campus /ID# 225586, Haifa, , Israel
NHO Nagoya Medical Center /ID# 244412, Nagoya-shi, Aichi, Japan
National Cancer Center Hospital East /ID# 225725, Kashiwa-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center /ID# 240821, Matsuyama-shi, Ehime, Japan
National Hospital Organization Kyushu Cancer Center /ID# 240761, Fukuoka-shi, Fukuoka, Japan
National Cancer Center Hospital /ID# 225724, Chuo-ku, Tokyo, Japan
National Cancer Center /ID# 231887, Goyang, Gyeonggido, Korea, Republic of
Yonsei University Health System Severance Hospital /ID# 233774, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Asan Medical Center /ID# 231886, Seoul, , Korea, Republic of
Samsung Medical Center /ID# 231888, Seoul, , Korea, Republic of
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 226096, Majadahonda, Madrid, Spain
Hospital Universitario Vall d'Hebron /ID# 225976, Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 225975, Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 225977, Madrid, , Spain
Hospital Universitario Virgen de la Victoria /ID# 225978, Malaga, , Spain
National Taiwan University Hospital - Hsinchu branch /ID# 243610, Hsinchu City, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 243345, Kaohsiung, , Taiwan
National Cheng Kung University Hospital /ID# 225944, Tainan, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 225946, Taoyuan City, , Taiwan
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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