Spots Global Cancer Trial Database for Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma
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Trial Identification
Brief Title: Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma
Official Title: A Phase 1 Study of TJ011133 Administered Alone or in Combination With Pembrolizumab or Rituximab in Subjects With Relapsed/Refractory Advanced Solid Tumors and Lymphoma
Study ID: NCT03934814
Study Description
Brief Summary: The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.
Detailed Description: This is an open-label, multi-center, multiple dose, Phase 1 study to evaluate the safety, tolerability, maximum tolerated dose (MTD) or maximum administered dose (MAD), pharmacokinetic (PK), pharmacodynamic, and recommended Phase 2 dose (RP2D) of TJ011133, an anti-CD47 antibody, in participants with advanced relapsed or refractory solid tumors and lymphoma. The study will be conducted in 2 parts. Part 1 comprises a single agent dose escalation (Part 1A) and 2 separate combination therapy dose escalations (Part 1B with pembrolizumab and Part 1C with rituximab) and Part 2 includes a dose expansion study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama - Birmingham ID# 233979, Birmingham, Alabama, United States
Mayo Clinic /ID# 233546, Scottsdale, Arizona, United States
Yale School of Medicine /ID# 233748, New Haven, Connecticut, United States
Mayo Clinic /ID# 233977, Jacksonville, Florida, United States
Horizon Oncology /ID# 234256, Lafayette, Indiana, United States
University of Michigan /ID# 233976, Ann Arbor, Michigan, United States
Henry Ford Cancer Institute/Henry Ford Hospital /ID# 234122, Detroit, Michigan, United States
Mayo Clinic /ID# 233305, Rochester, Minnesota, United States
Rutgers Cancer Institute of New Jersey /ID# 232267, New Brunswick, New Jersey, United States
NYU Langone Health /ID# 233978, New York, New York, United States
Vanderbilt-Ingram Cancer Center /ID# 233975, Nashville, Tennessee, United States
Seattle Cancer Care Alliance /ID# 233749, Seattle, Washington, United States
Beijing Cancer Hospital /ID# 241221, Beijing, Beijing, China
Sun Yat-sen University Cancer Center /ID# 241696, Guangzhou, Guangdong, China
The Fourth Hpspital of Hebei Medical University(Hebei Cancer Hospital) / ID# 242333, Shijiazhuang, Hebei, China
Henan Cancer Hospital /ID# 241670, Zhengzhou, Henan, China
HuBei Cancer Hospital /ID# 241673, Wuhan, Hubei, China
The Second Hospital of Dalian Medical University /ID# 241671, Dalian, Liaoning, China
Fudan University Shanghai Cancer Center /ID# 242303, Shanghai, Shanghai, China
Tianjin Medical University Cancer Institute & Hospital / ID# 241728, Tianjin, Tianjin, China
Zhejiang Cancer Hospital /ID# 241672, Hangzhou, Zhejiang, China
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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