A Study of NX-1607 for Advanced Cancers
This study is testing a new oral drug called NX-1607, alone or with paclitaxel (a chemotherapy drug), for adults with advanced cancers like ovarian, gastric, head and neck, or melanoma that has spread or cannot be removed. The study aims to see how safe NX-1607 is and if it can shrink tumors. Researchers will look at side effects, including serious ones and those related to the immune system, over about 16 months to 2 years. They will also measure how many people respond to the treatment over up to 3 years. You might be able to join if you are 18 or older, have measurable cancer that has spread or can't be removed, and have already tried standard treatments or can't receive them.
- Study design
- This is a Phase 1a/1b study, meaning it's an early-stage study to test safety and initial effectiveness. It is open-label, so both you and your doctors will know which treatment you are receiving. The study plans to enroll about 345 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will track side effects for up to 2 years and measure how well the treatment works for up to 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05107674
A Study of NX-1607 in Adults With Advanced Malignancies
Recruiting
PHASE1Ages 18+InterventionalTreatmentNurix Therapeutics, Inc.
~345 participants
Updated 2025-09-09 on ClinicalTrials.gov
What's tested:NX-1607Paclitaxel
At a glance
Recruiting sites
15 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over 16 months
+2 more outcomes measured
Conditions
Where it's being run
17 sites across 10 statesUnited Kingdom6
California3
Colorado1
Illinois1
North Carolina1
Oklahoma1
Texas1
Virginia1
Study leadership
- Linda Neuman, MD · STUDY_DIRECTOR · Nurix Therapeutics, Inc.
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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).
Exclusion
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.
What this trial measures
- 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 TEAEs16 months
Phase 1a
- Incidence of immune-related AEs (irAEs), all deaths, and dose-limiting toxicities (DLTs)Up to 2 Years
Phase 1a
- Objective Response Rate (ORR) per disease-specific response criteria as assessed by the InvestigatorUp to 3 Years
Phase 1b