A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies

Part of paid clinical trials in Duarte, California.

Sponsor
Nurix Therapeutics, Inc.
Study ID
NCT04830137
Phase
PHASE1
Status
Recruiting
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Conditions

  • Chronic Lymphocytic Leukemia (CLL)
  • Diffuse Large B-cell Lymphoma (DLBCL)
  • Follicular Lymphoma (FL)
  • Mantle Cell Lymphoma (MCL)
  • Marginal Zone Lymphoma (MZL)
  • Primary Central Nervous System Lymphoma (PCNSL)
  • Small Lymphocytic Lymphoma (SLL)
  • Waldenstrom Macroglobulinemia (WM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NX-2127 — DRUG
    Oral NX-2127

Study Details

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.

Key Dates

First listed
Apr 2, 2021
Start date
May 5, 2021
Status verified
Mar 2026
Primary completion
May 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
248 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Number of Participants with Protocol Specified Dose-Limiting Toxicities [ Time Frame: Up to 24 months ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
University of California IrvineOrangeCalifornia92868-
University of California San Francisco Medical CenterSan FranciscoCalifornia94143-
Sarah Cannon Research Institute at Colorado Blood Cancer InstituteDenverColorado80218-
Mount Sinai Comprehensive Cancer CenterMiami BeachFlorida33140-
Sarah Cannon Research Institute at Florida Cancer SpecialistsSarasotaFlorida34203-
The University of Chicago Medical CenterChicagoIllinois60637-
National Institutes of Health Clinical CenterBethesdaMaryland20814-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of Cincinnati Medical CenterCincinnatiOhio45267-
OSU Wexner Medical CenterColumbusOhio43210-
Tennessee OncologyNashvilleTennessee37203-
Baylor University Medical CenterDallasTexas75246-
MD Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer Institute, University of UtahSalt Lake CityUtah84112-
Swedish Cancer InstituteSeattleWashington98104-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAUniversity of California Irvine· Orange, CAUniversity of California San Francisco Medical Center· San Francisco, CASarah Cannon Research Institute at Colorado Blood Cancer Institute· Denver, COMount Sinai Comprehensive Cancer Center· Miami Beach, FLSarah Cannon Research Institute at Florida Cancer Specialists· Sarasota, FL

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