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Brief Title: A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies
Official Title: A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults With Relapsed/Refractory B-cell Malignancies
Study ID: NCT05131022
Brief Summary: This is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of NX-5948 in patients with advanced B-cell malignancies.
Detailed Description: Phase 1a is a dose escalation to evaluate the safety and tolerability of NX-5948 in adult patients with relapsed/refractory (R/R) B cell malignancies who have received at least 2 prior lines of therapy, or at least 1 prior line of therapy for Primary Central Nervous System Lymphoma (PCNSL), and for whom no other therapies are known to provide clinical benefit. Indications include: Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Diffuse Large B-cell Lymphoma (DLBCL), Mantle Cell Lymphoma (MCL), Waldenstrom Macroglobulinemia (WM), Marginal Zone Lymphoma (MZL), Follicular Lymphoma (FL), or Primary Central Nervous System Lymphoma (PCNSL). Phase 1b will investigate the efficacy of NX-5948 at the dose(s) selected in Phase 1a in up to 7 expansion arms of patients with histologically confirmed R/R B-cell malignancy indications who have received the specified prior therapies based on indication: * CLL or SLL (two dose levels will be investigated for CLL/SLL) * MCL * MZL * WM * DLBCL * FL * PCNSL/SCNSL
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, United States
University of California, San Francisco, San Francisco, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
University of Miami, Miami, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Duke University Medical Center, Durham, North Carolina, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
MD Anderson Cancer Center, Houston, Texas, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Radboud University Medical Center, Nijmegen, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
University Medical Center Utrecht, Utrecht, , Netherlands
The Beatson WOS Cancer Center, Glasgow, Scotland, United Kingdom
St. James Hospital, Leeds, , United Kingdom
Clatterbridge Cancer Center NHS Foundation Trust, Liverpool, , United Kingdom
St. Bartholomew's Hospital, Barts NHS Trust, London, , United Kingdom
Sarah Cannon Research Institute UK, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Oxford University Hospitals NHS Foundation Trust, Oxford, , United Kingdom
University Hospitals Plymouth NHS Trust, Plymouth, , United Kingdom
University Hospital Southampton NHS Foundation Trust, Southampton, , United Kingdom
Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
Name: Paula O'Connor, MD
Affiliation: Nurix Therapeutics, Inc.
Role: STUDY_DIRECTOR