Recruiting
Phase 1

NX-1607

Sponsor:

Nurix Therapeutics, Inc.

Code:

NCT05107674

Conditions

Ovarian Cancer, Epithelial

Gastric Cancer

GastroEsophageal Junction (GEJ) Cancer

Head and Neck Squamous Cell Carcinoma

Metastatic or Unresectable Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NX-1607

Paclitaxel

Study Details

Brief 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-1607 in patients with advanced malignancies.

Conditions

Ovarian Cancer, Epithelial

Gastric Cancer

GastroEsophageal Junction (GEJ) Cancer

Head and Neck Squamous Cell Carcinoma

Metastatic or Unresectable Melanoma

Study ID

NCT05107674

Start date

Sep 29, 2021

Status verified date

Sep, 2025

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Age ≥ 18 years.
  • Measurable disease per disease-specific response criteria.
  • Patients must have disease that is metastatic or unresectable and have received standard treatment options, are not candidates for standard treatment options, or will otherwise be prevented from receiving any standard treatment options.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Minimum of 3 weeks or 5 half-lives (whichever is shorter) since last dose of systemic cancer therapy (unless otherwise specified) or minimum of 2 weeks since last radiotherapy, or minimum of 6 weeks since last systemic therapy with nitrosoureas, antibody-drug conjugate, or radio immuno-conjugate therapy.
  • Adequate organ and bone marrow function, in the absence of growth factors (with limited exception for DLBCL), as defined by laboratory parameters.
  • Patients of child-bearing potential must use adequate contraceptive measures to avoid pregnancy for the duration of the study as defined in the protocol.
  • Patient must be willing and able to adhere to the prohibitions and restrictions specified in the protocol.
  • Each patient must sign an informed consent form (ICF).
  • Histological or cytological diagnosis of platinum-resistant EOC, including primary peritoneal and fallopian tube carcinoma; gastric/GEJ cancer; HNSCC; recurrent and either metastatic or unresectable melanoma; NSCLC; mCRPC; MPM; TNBC; locally advanced or metastatic urothelial cancer; cervical cancer; MSS CRC; or DLBCL (including DLBCL-RT)
  • Accessible tumor (for all cohorts) or lymph node (DLBCL only) for biopsy (Phase 1b only).

Key Exclusion Criteria:

  • Active untreated brain metastases.
  • Patient has any of the following:
  • Uncontrolled intercurrent illness including, but not limited to, poorly controlled hypertension or diabetes, or ongoing active infection requiring systemic therapy.
  • Patients with primary refractory EOC defined as patients who do not respond to their first platinum-containing regimen or who relapse less than 6 months after completion of that first platinum-containing regimen
  • Psychiatric illness that would limit compliance with study requirements.
  • Treatment with any of the following prior to the first dose of NX-1607: CPI (anti-PD-1, PD-L1, cytotoxic T-lymphocyte-associated protein 4, etc) within 3 weeks; autologous or allogeneic stem cell transplant within 100 days; prior systemic cancer therapy within 3 weeks or 5 half-lives (whichever is shorter) (unless otherwise specified) (including hormonal therapy except for hormonal prophylaxis for a prior malignancy); prior radiotherapy within 2 weeks; prior systemic therapy with nitrosoureas, antibody-drug conjugate, or radio-immuno-conjugate therapy within 6 weeks; use of strong or moderate CYP3A4 inducers or inhibitors within 14 days or 7 days, respectively, or 5 half-lives (whichever is longer)
  • History of CAR-T therapy within 30 days prior to the first dose of NX-1607.
  • Toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to Grade 1 or less except for Grade 2 alopecia and Grade 2 peripheral neuropathy or patients receiving endocrine replacement therapy
  • Patients who experienced Grade 3 or higher irAEs with prior immunotherapy.
  • History of uveitis, or an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • Unable to swallow capsules or has malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction likely to interfere with the delivery, absorption, or metabolism of NX-1607.
  • Known allergies, hypersensitivity, or intolerance to components of NX-1607.
  • Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of NX-1607.
  • Patient is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of NX-1607 and, as applicable, within 6 months after the last dose of paclitaxel.
  • Patient has had major surgery (e.g., requiring general anesthesia) within 4 weeks before the planned first dose of NX-1607, or will not have fully recovered from surgery, or has surgery planned during the time the patient is expected to participate in the study or within 4 weeks after the last dose of NX-1607. Note: Patients with minor planned surgical procedures to be conducted under local anesthesia may participate.
  • Vaccinated with a live vaccine within 28 days (with the exception of the annual inactivated influenza vaccine) or COVID-19 vaccination within 14 days prior to the first dose of NX-1607.
  • Active known second malignancy with the exception of any of the following:

  • Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer.
  • Adequately treated Stage I cancer from which the patient is currently in remission and has been in remission for ≥ 2 years.
  • Low-risk prostate cancer with Gleason score < 7 and PSA < 10 ng/mL.
  • Any other cancer from which the patient has been disease-free for ≥ 2 years.
  • 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 hepatitis, including hepatitis A (hepatitis A virus immunoglobulin M \[IgM\] positive), hepatitis B (hepatitis B virus \[HBV\] surface antigen positive), or hepatitis C (hepatitis C virus \[HCV\] antibody positive, confirmed by HCV RNA). Patients with HCV with undetectable virus after treatment are eligible. Patients with prior exposure to HBV may be entered if quantitative PCR is negative.
  • Use of systemic corticosteroids (> 20 mg prednisone or equivalent) within 15 days (except for prophylaxis for radio diagnostic contrast reactions and/or prophylaxis for patients receiving paclitaxel), or other immunosuppressive drugs within 30 days, prior to the first dose of NX-1607.
  • Use of biotin (i.e., Vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 µg \[NIH 2020\] (Note: Patients who switch from a high dose to a dose of 30 µg/day or less at least 1 day prior to Screening assessments are eligible for study entry).
  • Receipt of an IP or has been treated with an investigational device within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of NX-1607.
  • Any of the following within 6 months prior to the first dose of NX-1607 or ongoing:

  • Myocardial infarction
  • Unstable angina
  • Unstable symptomatic ischemic heart disease
  • New York Heart Association Class III or IV heart failure
  • Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events)
  • Any other significant cardiac condition (e.g., pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, or severe congenital heart disease)
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator in consultation with the Medical Monitor.

Study Design

Enrollment

345 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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)

Interventions

NX-1607

Oral NX-1607

Paclitaxel

Paclitaxel IV

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 ]
  • Incidence of immune-related AEs (irAEs), all deaths, and dose-limiting toxicities (DLTs) [ Time Frame: Up to 2 Years ]
  • Objective Response Rate (ORR) per disease-specific response criteria as assessed by the Investigator [ Time Frame: Up to 3 Years ]

Central Contacts and Locations

Central contacts

Nurix Therapeutics Patient Outreach

4152307815nx1607101@nurixtx.com

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90007

Contacts

Xiomara Menendez

Xiomara.Menendez@med.usc.edu

Lorraine Martinez

Lorraine.Martinez@med.usc.edu

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Early Phase Clinical Trials

earlyphaseclinicaltrials@ucsf.edu

University of Colorado School of Medicine

Recruiting

Aurora, Colorado, United States, 80045

Contacts

BRANDI.ASHEIM@CUANSCHUTZ.EDU

Principal Investigator:

Wells Messersmith, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Clinical Trials Office

cancerclinicaltrials@bsd.uchicago.edu

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Clinical Trials Office

919-966-4432cancerclinicaltrials@med.unc.edu

University of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Christina-Caldwell@ouhsc.edu

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Rabia Khan

rkhan@mdanderson.org

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Chrystal Axford

CGP9E@uvahealth.org

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Phase 1 Research Program

phase1clinicaltrial@fredhutch.org

More Information

Sponsor

Nurix Therapeutics, Inc.

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • Ubiquitin Ligase Inhibitor
  • Advanced Malignancies
  • T-cell Activation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Nurix Therapeutics, Inc. on 2025-09-09.