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

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients must be ≥ 18 years of age

• Patients must have measurable disease per disease-specific response criteria

• Patients with indolent forms of NHL must meet the criteria requiring systemic treatment (i.e., iwCLL, IWG, Lugano Classification of Lymphoma response criteria, or International PCNSL Collaborative Group response criteria)

• Patients with transformed lymphoma are eligible for the study with the exception of those detailed in Exclusion Criteria #1: Prolymphocytic leukemia, MCL with blastoid histology, MCL with pleomorphic morphology, or MCL with known TP53 mutation

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (non-PCNSL indications) or 0 - 2 (PCNSL patients)

• Adequate organ and bone marrow function

• Patients of child-bearing potential must use adequate contraceptive measures to avoid pregnancy for the duration of the study as defined in the protocol

• Have histologically confirmed R/R CLL, SLL, WM, MCL, and MZL, FL, DLBCL, or PCNSL

• Received at least 2 prior systemic therapies (or at least 1 prior therapy for patients with WM or PCNSL) and have no other therapies known to provide clinical benefit

• Must require systemic therapy

• Must have one of the following histologically documented R/R B-cell malignancies:

‣ CLL/SLL whose disease has failed treatment with a BTKi;

⁃ MCL whose disease has failed treatment with BTKi and an anti-CD20 mAb-based regimen

⁃ FL or MZL whose disease has failed treatment with an anti-CD20 mAb-based regimen; or WM whose disease has failed treatment with a BTKi

⁃ PCNSL whose disease failed at least 1 prior line of treatment

⁃ DLBCL whose disease has failed treatment with an anti-CD20 mAb-based regimen and either: an anthracycline-based regimen; or an anti-CD19-based regimen, or another/ palliative regimen (either progressed post stem cell transplant or transplant-ineligible)

Locations
United States
California
City of Hope
RECRUITING
Duarte
University of California Irvine
COMPLETED
Orange
University of California San Francisco Medical Center
COMPLETED
San Francisco
Colorado
Sarah Cannon Research Institute at Colorado Blood Cancer Institute
RECRUITING
Denver
Florida
Mount Sinai Comprehensive Cancer Center
COMPLETED
Miami Beach
Sarah Cannon Research Institute at Florida Cancer Specialists
COMPLETED
Sarasota
Illinois
The University of Chicago Medical Center
RECRUITING
Chicago
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
New York
Memorial Sloan Kettering Cancer Center
COMPLETED
New York
Ohio
University of Cincinnati Medical Center
COMPLETED
Cincinnati
OSU Wexner Medical Center
COMPLETED
Columbus
Tennessee
Tennessee Oncology
RECRUITING
Nashville
Texas
Baylor University Medical Center
COMPLETED
Dallas
MD Anderson Cancer Center
RECRUITING
Houston
Utah
Huntsman Cancer Institute, University of Utah
RECRUITING
Salt Lake City
Washington
Swedish Cancer Institute
COMPLETED
Seattle
Contact Information
Primary
Patient Outreach
nx2127001@nurixtx.com
(415)-230-7806
Time Frame
Start Date: 2021-05-05
Estimated Completion Date: 2026-12
Participants
Target number of participants: 248
Treatments
Experimental: Phase 1a Dose Escalation
Multiple dose levels of NX-2127 to be evaluated; determination of MTD/Phase 1b recommended dose
Experimental: Phase 1b Dose Optimization Stage 1 in CLL or SLL (Dose A)
CLL/SLL patients whose disease has failed treatment with a BTK inhibitor
Experimental: Phase 1b Dose Optimization Stage 1 in MCL (Dose A)
MCL patients whose disease has failed treatment with a BTK inhibitor and an anti-CD20 monoclonal antibody (mAb) based regimen
Experimental: Phase 1b Dose Optimization Stage 1 in FL, MZL or WM (Dose A)
FL or MZL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen; or WM whose disease has failed treatment with a BTK inhibitor
Experimental: Phase 1b Dose Optimization Stage 1 in DLBCL (Dose A)
DLBCL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen and either: an anthracycline-based regimen; or an anti-CD19-based regimen; or another/palliative regimen
Experimental: Phase 1b Dose Optimization Stage 1 in PCNSL (Dose A)
PCNSL patients whose disease has failed at least 1 prior line of treatment
Experimental: Phase 1b Dose Optimization Stage 2 in CLL or SLL (Randomized to Dose A or Dose B)
CLL/SLL patients whose disease has failed treatment with a BTK inhibitor
Experimental: Phase 1b Dose Optimization Stage 2 in MCL (Randomized to Dose A or Dose B)
MCL patients whose disease has failed treatment with a BTK inhibitor and an anti-CD20 monoclonal antibody (mAb) based regimen
Experimental: Phase 1b Dose Optimization Stage 2 in FL, MZL or WM (Randomized to Dose A or Dose B)
FL or MZL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen; or WM whose disease has failed treatment with a BTK inhibitor
Experimental: Phase 1b Dose Optimization Stage 2 in DLBCL (Randomized to Dose A or Dose B)
DLBCL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen and either: an anthracycline-based regimen; or an anti-CD19-based regimen; or another/palliative regimen
Experimental: Phase 1b Dose Optimization Stage 2 in PCNSL (Randomized to Dose A or Dose B)
PCNSL patients whose disease has failed at least 1 prior line of treatment
Sponsors
Leads: Nurix Therapeutics, Inc.

This content was sourced from clinicaltrials.gov