Spots Global Cancer Trial Database for A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies
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Trial Identification
Brief Title: A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies
Official Title: A Phase 1, Dose Escalation, Safety and Tolerability Study of NX-2127, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults With Relapsed/Refractory B-cell Malignancies
Study ID: NCT04830137
Interventions
Study Description
Brief Summary: This is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-2127 in patients with advanced B-cell malignancies.
Detailed Description: Phase 1a is a dose escalation to evaluate the safety and tolerability of NX-2127 in adult patients with relapsed/refractory (R/R) B-cell malignancies, who have required and received at least 2 prior systemic therapies (or at least 1 prior therapy for patients with WM or PCNSL) and for whom no other therapies are known to provide clinical benefit. Phase 1b will investigate the efficacy of NX-2127 at the dosage(s) selected in Phase 1a in up to 5 cohorts of patients with R/R B-cell malignancy indications who have received at least 2 prior systemic therapies (or at least 1 prior therapy for patients with WM or PCNSL): * Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) with no BTK C481 mutation * BTK C481 mutation-positive CLL/SLL * Mantle Cell Lymphoma (MCL) * Follicular lymphoma (FL) or Marginal Zone Lymphoma (MZL); or Primary Central Nervous System Lymphoma (PCNSL) * Diffuse Large B-cell Lymphoma (DLBCL) or Waldenstrom Macroglobulinemia (WM)
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
University of California Irvine, Orange, California, United States
University of California San Francisco Medical Center, San Francisco, California, United States
Sarah Cannon Research Institute at Colorado Blood Cancer Institute, Denver, Colorado, United States
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
Sarah Cannon Research Institute at Florida Cancer Specialists, Sarasota, Florida, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
OSU Wexner Medical Center, Columbus, Ohio, United States
Sarah Cannon Research Institute at Tennessee Oncology, Nashville, Tennessee, United States
Baylor University Medical Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, United States
Swedish Cancer Institute, Seattle, Washington, United States
Contact Details
Name: Paula O'Connor, MD
Affiliation: Nurix Therapeutics, Inc.
Role: STUDY_DIRECTOR
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