A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies
NCT ID: NCT04830137
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
248 participants
INTERVENTIONAL
2021-05-05
2026-12-31
Brief Summary
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Detailed Description
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Phase 1b (Dose Optimization) will use a 2-stage design to further investigate the safety, tolerability, and preliminary efficacy of NX-2127 in R/R B-cell malignancies based on the dosage(s) selected in Phase 1a.
Stage 1 will enroll approximately 10 participants per group based on B-cell lymphoma/leukemia indication at a specific dose selected from the first part of the study. The Sponsor may decide to open Stage 2 for any given group after review of safety and anti-tumor activity data from Stage 1.
In Stage 2, an additional 10 participants will be enrolled at the dose from Stage 1 as well as 20 additional participants at a second alternative dose. Participants will be randomly assigned to one of the 2 dose levels in Stage 2.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a Dose Escalation
Multiple dose levels of NX-2127 to be evaluated; determination of MTD/Phase 1b recommended dose
NX-2127
Oral NX-2127
Phase 1b Dose Optimization Stage 1 in CLL or SLL (Dose A)
CLL/SLL patients whose disease has failed treatment with a BTK inhibitor
NX-2127
Oral NX-2127
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
NX-2127
Oral NX-2127
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
NX-2127
Oral NX-2127
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
NX-2127
Oral NX-2127
Phase 1b Dose Optimization Stage 1 in PCNSL (Dose A)
PCNSL patients whose disease has failed at least 1 prior line of treatment
NX-2127
Oral NX-2127
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
NX-2127
Oral NX-2127
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
NX-2127
Oral NX-2127
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
NX-2127
Oral NX-2127
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
NX-2127
Oral NX-2127
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
NX-2127
Oral NX-2127
Interventions
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NX-2127
Oral NX-2127
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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)
* Active known second malignancy. Exception: patients with non-metastatic, non-melanoma skin cancer are eligible
* Patient has had major surgery (e.g. requiring general anesthesia) within 4 weeks before the planned first dose of study drug
* Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: patients with well-controlled HIV (e.g., CD4 \> 350/mm3 and undetectable viral load) are eligible.
* Current active liver disease from any cause
* Active viral reactivation (e.g., CMV or EBV)
* Use of systemic corticosteroids exceeding 20 mg/day prednisone (or equivalent) for non-PCNSL indications within 15 days prior to the planned start of study drug. PCNSL patients may not exceed corticosteroid doses of 40 mg/day prednisone (or equivalent) and should be on a stable or decreasing dose for 7 days prior to planned study start.
* Use of non-steroidal immunosuppressive drugs within 30 days prior to start of the study
* Clinically significant, uncontrolled cardiac, cardiovascular disease, or history of myocardial infarction within 6 months of planned start of study drug
* Administration of any strong cytochrome P450 3A (CYP3A) inducers or inhibitors for 14 days prior to the first dose of study drug, and any P-glycoprotein inhibitors (for 2 days) or moderate inducers of CYP3A for 7 days
Exclusion Criteria
* 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
* Active, uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia
* History of known/suspected other autoimmune disease (exception(s): patients with alopecia, vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed.)
* Unable to swallow capsules or have a condition that may interfere in the delivery, absorption, or metabolism of the study drug
* Bleeding diathesis, or other known risk for acute blood loss
* Patients requiring ongoing treatment with warfarin or an equivalent vitamin K antagonist and within 7 days prior to the first dose of study drug
* Prior radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation)
18 Years
ALL
No
Sponsors
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Nurix Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paula O'Connor, MD
Role: STUDY_DIRECTOR
Nurix Therapeutics, Inc.
Locations
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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
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
Countries
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Central Contacts
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References
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Zhang D, Harris HM, Chen J, Judy J, James G, Kelly A, McIntosh J, Tenn-McClellan A, Ambing E, Tan YS, Lu H, Gajewski S, Clifton MC, Yung S, Robbins DW, Pirooznia M, Skanland SS, Gaglione E, Mhibik M, Underbayev C, Ahn IE, Sun C, Herman SEM, Noviski M, Wiestner A. NRX-0492 degrades wild-type and C481 mutant BTK and demonstrates in vivo activity in CLL patient-derived xenografts. Blood. 2023 Mar 30;141(13):1584-1596. doi: 10.1182/blood.2022016934.
Other Identifiers
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NX-2127-001
Identifier Type: -
Identifier Source: org_study_id
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