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Evaluating NX-1607 for advanced cancers

A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage Lymphoma Proto-oncogene (CBL-B) Inhibitor, in Adults With Advanced Malignancies, With Phase 1b Expansion in Select Tumor Types

Phase 1 Interventional Nurix Therapeutics, Inc. · NCT05107674

This study is testing a new treatment called NX-1607 to see if it can help people with advanced cancers who have run out of other options.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment345 (estimated)
Ages18 Years and up
SexAll
SponsorNurix Therapeutics, Inc. Industry-sponsored
Drugs / interventionsCAR-T, immunotherapy, prednisone
Locations17 sites (Duarte, California and 16 other locations)
Trial IDNCT05107674 on ClinicalTrials.gov

What this trial studies

This Phase 1a/1b multicenter, open-label oncology study aims to assess the safety and anti-cancer activity of NX-1607 in adults with advanced malignancies. The study consists of two phases: Phase 1a focuses on dose escalation to evaluate safety and tolerability, while Phase 1b investigates efficacy as monotherapy or in combination with paclitaxel for specific advanced cancers. Eligible patients include those with metastatic or unresectable tumors who have exhausted standard treatment options. The study will provide insights into the potential of NX-1607 as a new therapeutic option for patients with limited treatment choices.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors that are metastatic or unresectable and have received or are not candidates for standard treatment options.

Not a fit: Patients with early-stage cancers or those who have not yet received standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new treatment option for patients with advanced malignancies that currently have no effective standard therapies.

How similar studies have performed: Other studies exploring similar approaches with novel therapies have shown promise, but the specific use of NX-1607 is a novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Duarte, California and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ovarian Cancer, EpithelialGastric CancerGastroEsophageal Junction CancerHead and Neck Squamous Cell CarcinomaMetastatic or Unresectable MelanomaNon-small Cell Lung CancerMetastatic Castration-resistant Prostate CancerMalignant Pleural Mesothelioma
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.