Spots Global Cancer Trial Database for PRO1160 for Advanced Solid and Liquid Tumors (PRO1160-001)
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Trial Identification
Brief Title: PRO1160 for Advanced Solid and Liquid Tumors (PRO1160-001)
Official Title: Phase 1/2 Study of PRO1160 in Patients With Renal Cell Carcinoma (RCC), Nasopharyngeal Carcinoma (NPC), or Non-Hodgkin Lymphoma (NHL)
Study ID: NCT05721222
Interventions
Study Description
Brief Summary: Brief Summary: This study will test the safety, including side effects, and determine the characteristics of a drug called PRO1160 in participants with solid tumors. Participants will have solid tumor or liquid cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This Phase 1/2 study will have two parts. Part A of the study will find out how much and how frequently PRO1160 should be given to participants. Part B will use the dose and schedule found in Part A to find out how safe PRO1160 is and if it works to treat the diseases under study. The diseases under study will be Renal Cell Carcinoma (RCC),Nasopharyngeal Carcinoma (NPC) and Non-Hodgkin Lymphoma (NHL).
Detailed Description: This is a Phase 1/2 study of PRO1160, a CD70 targeted antibody-drug conjugate, to evaluate the safety, tolerability, PK, and antitumor activity of PRO1160 in patients with selected locally advanced /or metastatic solid and liquid tumors, including renal cell carcinoma, nasopharyngeal carcinoma and non-hodgkin lymphoma. This study consists of 2 parts, Part A: Dose Escalation and Part B: Dose Expansion. Part A may evaluate up to 7 dose levels of PRO1160 on Day 1 of a 21 day cycle by IV infusion. Part B will be initiated at a dose level based on a comprehensive analysis of safety, tolerability, clinical PK, PD and activity data from Part A in up to 4 different cohorts of up to 20 patients per cohort. Patients will continue to receive study treatment until the first instance of disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the Sponsor, pregnancy, or death.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Comprehensive Cancer Center - Duarte, Duarte, California, United States
The City of Hope Orange County Lennar Foundation Cancer Center, Irvine, California, United States
University of Michigan, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Washington University School of Medicine in St. Louis, Saint Louis, Missouri, United States
Montefiore Medical Center - Montefiore Hospital, Bronx, New York, United States
NYU Langone Health, New York, New York, United States
Levine Cancer Center, Charlotte, North Carolina, United States
Cleveland Clinic - Euclid Hospital, Cleveland, Ohio, United States
Providence Portland Medical Center, Portland, Oregon, United States
Oregon Health & Science University, Portland, Oregon, United States
Sarah Cannon Research Institute - Nashville, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
START Mountain Cancer Center, West Valley City, Utah, United States
Cancer Hospital of Chinese Academy of Medical Sciences, Beijing, Beijing, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China
Contact Details
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