Spots Global Cancer Trial Database for Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors
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Trial Identification
Brief Title: Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors
Official Title: A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-706 as Monotherapy and in Combination With Budigalimab (ABBV-181), Carboplatin, or Cisplatin in Adult Subjects With Advanced Solid Tumors
Study ID: NCT05599984
Conditions
Study Description
Brief Summary: Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab, carboplatin, or cisplatin. ABBV-706 is an investigational drug being developed for the treatment of small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine carcinomas (NECs). There are multiple treatment arms in this study. Participants will either receive ABBV-706 as a single agent or in combination with budigalimab (another investigational drug), carboplatin or cisplatin at different doses. Approximately 350 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), ABBV-706 will be intravenously infused in escalating doses as a monotherapy until the maximum tolerated dose (MTD) is determined in participants with SCLC, high-grade CNS tumors, and high-grade NECs. In part 2, multiple doses will be selected from Part 1 and SCLC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. In Part 3a, participants with SCLC or NECs will receive ABBV-706 in combination with budigalimab intravenously every 3 weeks. In Part 3b participants with SCLC or NECs will receive ABBV-706 in combination with either carboplatin or cisplatin intravenously. In Part 4a, participants with CNS tumors will receive ABBV-706 intravenously at a dose determined from Part 1. In Part 4b, participants with NECs will receive ABBV-706 intravenously at a dose selected from Part 1. The estimated duration of the study is up to 3 years. 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 and may require frequent medical assessments, blood tests, and scans.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Ctr /ID# 260129, Gilbert, Arizona, United States
City of Hope /ID# 259884, Duarte, California, United States
Yale School of Medicine /ID# 246647, New Haven, Connecticut, United States
Georgetown University Hospital /ID# 255352, Washington, District of Columbia, United States
Fort Wayne Medical Oncology and Hematology, Inc /ID# 260130, Fort Wayne, Indiana, United States
University of Iowa Hospitals and Clinics /ID# 246638, Iowa City, Iowa, United States
Barbara Ann Karmanos Cancer In /ID# 261799, Detroit, Michigan, United States
Henry Ford Hospital /ID# 246648, Detroit, Michigan, United States
START Midwest /ID# 251257, Grand Rapids, Michigan, United States
St. Luke's Hosp. of Kansas City /ID# 259958, Kansas City, Missouri, United States
Washington University-School of Medicine /ID# 246286, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 246303, New York, New York, United States
Duke Cancer Center /ID# 246285, Durham, North Carolina, United States
UH Cleveland Medical Center /ID# 246641, Cleveland, Ohio, United States
Univ Oklahoma HSC /ID# 250884, Oklahoma City, Oklahoma, United States
Tennessee Oncology, PLLC /ID# 246283, Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center /ID# 246287, Houston, Texas, United States
South Texas Accelerated Research Therapeutics /ID# 248946, San Antonio, Texas, United States
University of Utah /ID# 246640, Salt Lake City, Utah, United States
Northwest Medical Specialties - Tacoma /ID# 262801, Tacoma, Washington, United States
The Kinghorn Cancer Centre /ID# 260874, Darlinghurst, New South Wales, Australia
Austin Health and Ludwig Institute for Cancer Research /ID# 255174, Heidelberg, Victoria, Australia
Peter MacCallum Cancer Ctr /ID# 259197, Melbourne, Victoria, Australia
Technische Universitat Dresden /ID# 259414, Dresden, , Germany
Rambam Health Care Campus /ID# 255059, Haifa, H_efa, Israel
The Chaim Sheba Medical Center /ID# 254915, Ramat Gan, Tel-Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 255147, Jerusalem, , Israel
National Cancer Center Hospital East /ID# 259417, Kashiwa-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center /ID# 261279, Matsuyama-shi, Ehime, Japan
Hokkaido Cancer Center /ID# 261278, Sapporo-shi, Hokkaido, Japan
Kyoto University Hospital /ID# 259419, Kyoto-shi, Kyoto, Japan
Shizuoka Cancer Center /ID# 261277, Sunto-gun, Shizuoka, Japan
The Cancer Institute Hospital Of JFCR /ID# 260132, Koto, Tokyo, Japan
Wakayama Medical University Hospital /ID# 260131, Wakayama-shi, Wakayama, Japan
National Cancer Center /ID# 248938, Goyang-si, Gyeonggido, Korea, Republic of
CHA Bundang Medical Center /ID# 248939, Seongnam, Gyeonggido, Korea, Republic of
Chonnam National University Hwasun Hospital /ID# 248943, Hwasun-gun, Jeonranamdo, Korea, Republic of
Yonsei University Health System Severance Hospital /ID# 248937, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital /ID# 248940, Seoul, , Korea, Republic of
Samsung Medical Center /ID# 248936, Seoul, , Korea, Republic of
Hospital Universitario Ramon y Cajal /ID# 257291, Madrid, , Spain
Hospital Universitario HM Sanchinarro /ID# 258657, Madrid, , Spain
Hospital Clinico Universitario de Valencia /ID# 257290, Valencia, , Spain
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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