A Study of NX-1607 in Adults With Advanced Malignancies

Part of paid clinical trials in Duarte, California.

Sponsor
Nurix Therapeutics, Inc.
Study ID
NCT05107674
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cervical Cancer
  • Diffuse Large B Cell Lymphoma (DLBCL)
  • Gastric Cancer
  • GastroEsophageal Junction (GEJ) Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Malignant Pleural Mesothelioma (MPM)
  • Metastatic Castration-resistant Prostate Cancer (mCRPC)
  • Metastatic Urothelial Carcinoma
  • Metastatic or Unresectable Melanoma
  • Microsatellite Stable Colorectal Carcinoma
  • Non-small Cell Lung Cancer (NSCLC)
  • Ovarian Cancer, Epithelial
  • Richter Transformation
  • Triple Negative Breast Cancer (TNBC)

Eligibility Criteria

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

Interventions

  • NX-1607 — DRUG
    Oral NX-1607
  • Paclitaxel — DRUG
    Paclitaxel IV

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-1607 in patients with advanced malignancies.

Key Dates

Start date
Sep 29, 2021
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Feb 28, 2028

Study Design

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

Arms

  • Experimental: Phase 1a Dose Escalation of NX-1607 (monotherapy)
    Multiple dose levels and dosing regimen of NX-1607 to be evaluated; determination of MTD/Phase 1b recommended dose.
  • Experimental: Phase 1a Food Effect
    Impact of food on NX-1607 bioavailability and tolerability to be evaluated
  • Experimental: Phase 1b Dose Expansion in platinum-resistant EOC
    Patients with platinum-resistant EOC, including primary peritoneal and fallopian tube carcinoma
  • Experimental: Phase 1b Dose Expansion in advanced gastric/GEJ cancer
    Patients with recurrent, locally advanced, or metastatic gastric or GEJ adenocarcinoma
  • Experimental: Phase 1b Dose Expansion in HNSCC
    Patients with recurrent, locally advanced, or metastatic HNSCC
  • Experimental: Phase 1b Dose Expansion in recurrent melanoma
    Patients with recurrent and either metastatic or unresectable Melanoma
  • Experimental: Phase 1b Dose Expansion in advanced NSCLC
    Patients with Stage IV NSCLC
  • Experimental: Phase 1b Dose Expansion in mCRPC
    Patients with mCRPC who received a minimum of 2 prior lines of therapy in the advanced setting including androgen receptor-directed therapy and a taxane-based chemotherapy and has PSA or radiographic progression
  • Experimental: Phase 1b Dose Expansion in mixed solid tumor cohort
    Cohort of mixed solid tumor indications consisting of patients with MPM, TNBC, locally advanced or metastatic urothelial cancer, cervical cancer, or DLBCL/DLBCL-RT
  • Experimental: Phase 1a Dose Escalation of NX-1607 in combination with Paclitaxel
    Indications may include but are not limited to, platinum resistant EOC, gastric/GEJ cancer. HSNCC, NSCLC, TNBC, locally advanced or metastatic urothelial cancer and cervical cancer.
  • Experimental: Phase 1b Dose Expansion of NX-1607 in combination with Paclitaxel
    Indications may include but are not limited to, platinum resistant EOC, gastric/GEJ cancer, HSNCC, NSCLC, TNBC, and locally advanced or metastatic urothelial cancer and cervical cancer
  • Experimental: Phase 1b Dose Expansion in MSS CRC
    Patients with histologically confirmed MSS CRC, known KRAS WT, and must have been previously treated with \> = 2 lines of systemic therapy including a fluoropyrimidine, irinotecan, and/or oxaliplatin (and EGFR inhibitor if known Ras wild type)

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs), including Grade ≥ 3 TEAEs, treatment-emergent serious adverse events (SAEs), TEAEs leading to study drug discontinuation, and deaths due to TEAEs [ Time Frame: 16 months ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
University of Southern CaliforniaLos AngelesCalifornia90007
Xiomara Menendez
[email protected]
Lorraine Martinez
[email protected]
University of California, San FranciscoSan FranciscoCalifornia94158
Early Phase Clinical Trials
[email protected]
University of Colorado School of MedicineAuroraColorado80045
Brandi Asheim
[email protected]
Wells Messersmith, MD (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Clinical Trials Office
[email protected]
University of North CarolinaChapel HillNorth Carolina27599
Clinical Trials Office
[email protected]
919-966-4432
University of OklahomaOklahoma CityOklahoma73104
Christina Caldwell
[email protected]
MD Anderson Cancer CenterHoustonTexas77030
University of VirginiaCharlottesvilleVirginia22908
Chrystal Axford
[email protected]
Fred Hutchinson Cancer CenterSeattleWashington98109
Phase 1 Research Program
[email protected]

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City of Hope· Duarte, CAUniversity of Southern California· Los Angeles, CAUniversity of California, San Francisco· San Francisco, CAUniversity of Colorado School of Medicine· Aurora, COUniversity of Chicago· Chicago, ILUniversity of North Carolina· Chapel Hill, NC

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