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Spots Global Cancer Trial Database for A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies

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Trial Identification

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

Interventions

NX-5948

Study Description

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

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, 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

Contact Details

Name: Paula O'Connor, MD

Affiliation: Nurix Therapeutics, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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