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Looking for participantsPhase1

A Study of NX-1607 in Adults With Advanced Malignancies

Sponsor: Nurix Therapeutics, Inc.

NCT ID: NCT05107674

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
NX-1607 (drug), Paclitaxel (drug)
How long the study runs
Study runs about 77 months (dates as stated)
About the drug or intervention
NX-1607 — drug: Oral NX-1607 · Paclitaxel — drug: Paclitaxel IV
Patient visit burden
Not specified by the sponsor

In plain English

This study tests a new medicine called NX-1607 in adults with several types of advanced cancer, including ovarian, stomach, lung, skin, breast, prostate and others, that has spread or cannot be removed by surgery. NX-1607 is taken as a capsule. The study is run by Nurix Therapeutics, Inc.

Who can take part

  • Age 18 or over
  • Cancer has spread or cannot be removed by surgery, and standard treatment has been tried, is not suitable, or is not available
  • Cancer can be measured on scans or tests
  • Fairly well and able to carry out light activity (performance status 0 or 1)
  • A gap since your last cancer treatment (for example, at least 3 weeks since most cancer medicines and at least 2 weeks since radiotherapy)
  • Healthy enough organs and bone marrow, shown by blood tests
  • Use contraception to avoid pregnancy during the study, if this applies to you
  • A confirmed diagnosis by tissue testing of one of the cancers listed in the study
  • Willing and able to follow the study rules and sign a consent form
  • For part of the study (Phase 1b), have a tumour or lymph node that can be biopsied

Who may not be able to

  • Untreated cancer spread to the brain that is active
  • Uncontrolled other illness, such as poorly controlled high blood pressure, diabetes, or an infection needing treatment
  • Ovarian cancer that did not respond to the first platinum treatment or came back within 6 months of it
  • Mental health illness that would make it hard to follow the study
  • Recent cancer treatment before the first dose (times vary by treatment type)
  • CAR-T cell therapy in the past 30 days
  • Side effects from earlier cancer treatment that have not got better, apart from some exceptions like mild hair loss or nerve tingling
  • Serious immune side effects (Grade 3 or higher) from earlier immunotherapy
  • Uveitis (eye inflammation) or an autoimmune disease needing treatment in the past 2 years, though replacement hormones such as thyroxine are allowed
  • Cannot swallow capsules, or gut problems that would affect how the medicine is absorbed
  • Allergy to any part of NX-1607
  • Pregnant, breastfeeding, or planning pregnancy during the study or for 6 months after the last dose
  • Men planning to father a child during the study or for 3 months after the last dose
  • Major surgery in the past 4 weeks, not fully recovered from surgery, or surgery planned during the study
  • A live vaccine in the past 28 days or a COVID-19 vaccine in the past 14 days (the yearly flu injection is fine)
  • Another active cancer, with some exceptions such as treated skin cancer or cancers cleared for 2 years or more
  • HIV, unless very well controlled; or active hepatitis, though some treated cases are allowed
  • High-dose steroid tablets or other immune-suppressing drugs recently
  • Taking more than 30 micrograms a day of biotin (Vitamin B7), unless you stop at least a day before screening
  • Recent serious heart problems, blood clots, or stroke in the past 6 months
  • Any other issue that the study doctor thinks would make taking part unsafe or unclear

What taking part involves

  • • Taking NX-1607, a medicine given as capsules by mouth
  • • For part of the study (Phase 1b), having a biopsy of your tumour or lymph node
  • • Blood tests to check organ and bone marrow function

Time commitment: Not stated — ask the trial team how often visits happen, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
345
Started
2021-09-29
Last checked
2025-09

Plain English Summary

What is this study?

  • • Testing a new treatment for ovarian cancer, epithelial
  • • Phase1 - 345 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with ovarian cancer, epithelial

Where?

  • • Sutton - Royal Marsden Hospital NHS Foundation Trust
  • • Cambridge - Addenbrookes Cambridge University Hospital
  • • Glasgow - Beatson West of Scotland Cancer Centre
  • • London - Sarah Cannon Research Institute
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

Phase 1a will consist of 2 study arms: Monotherapy and Paclitaxel combo. Phase 1a dose escalation will evaluate the safety and tolerability of NX-1607 in adult patients with advanced solid tumors for which standard therapy with proven clinical benefit does not exist, is no longer effective, or is not appropriate. Indications for monotherapy include platinum resistant epithelial ovarian cancer (EOC), gastric/gastroesophageal junction (GEJ) cancer, squamous cell carcinoma of the head and neck (HNSCC), recurrent and either metastatic or unresectable melanoma, non-small cell lung cancer (NSCLC), metastatic castration-resistant prostate cancer (mCRPC), malignant pleural mesothelioma (MPM), triple-negative breast cancer (TNBC), locally advanced or metastatic urothelial cancer, cervical cancer, and microsatellite stable colorectal cancer (MSS CRC), and diffuse large cell B-cell lymphoma (DLBCL) including patients with Richter transformation (DLBCL-RT). Indications for paclitaxel combo may include, but are not limited to, platinum-resistant EOC, gastric/GEJ cancer, HNSCC, NSCLC, TNBC, locally advanced or metastatic urothelial cancer, and cervical cancer at the Sponsor's discretion. Phase 1b will investigate the efficacy of NX-1607 as monotherapy or in combination with paclitaxel at the dose(s) selected in Phase 1a in select advanced malignancies for which standard therapy, including immunotherapy, with proven clinical benefit does not exist, is no longer effective, or is not appropriate. Indications include platinum-resistant EOC, including primary peritoneal and fallopian tube carcinoma, advanced gastric/GEJ cancer, HNSCC, recurrent and either metastatic or unresectable melanoma, advanced NSCLC, mCRPC, MSS CRC, mixed solid tumor cohort indications consisting of patients with MPM, TNBC, locally advanced or metastatic urothelial cancer, cervical cancer, and DLBCL including patients with DLBCL-RT. In Arm 1 (NX-1607 monotherapy), more than 1 dose level of NX-1607 may be tested in individual indications, each of which will constitute a separate cohort in Phase 1b.

Ovarian Cancer, EpithelialGastric CancerGastroEsophageal Junction (GEJ) CancerHead and Neck Squamous Cell CarcinomaMetastatic or Unresectable MelanomaNon-small Cell Lung Cancer (NSCLC)Metastatic Castration-resistant Prostate Cancer (mCRPC)Malignant Pleural Mesothelioma (MPM)Triple Negative Breast Cancer (TNBC)Metastatic Urothelial CarcinomaCervical CancerDiffuse Large B Cell Lymphoma (DLBCL)Richter TransformationMicrosatellite Stable Colorectal Carcinoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

PD-L1PSACD4antigen positiveantibody positivePCR is negative

What the study is looking for

  • ✓Age ≥ 18 years.
  • ✓cancer that can be measured on scans per disease-specific response criteria.
  • ✓activity scale (ECOG) performance status of 0 or 1.
  • ✓Adequate organ and bone marrow function, in the absence of growth factors (with limited exception for DLBCL), as...
  • ✓Patients of child-bearing potential must use adequate contraceptive measures to avoid pregnancy for the duration of...

Who cannot take part

  • ✗Active untreated brain metastases.
  • ✗Patient has any of the following:
  • ✗Uncontrolled intercurrent illness including, but not limited to, poorly controlled hypertension or diabetes, or...
  • ✗Psychiatric illness that would limit compliance with study requirements.
  • ✗History of CAR-T therapy within 30 days prior to the first dose of NX-1607.
See the full 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 Is This Study? (7 UK sites)

Royal Marsden Hospital NHS Foundation Trust

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Addenbrookes Cambridge University Hospital

Cambridge CB2 0QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Beatson West of Scotland Cancer Centre

Glasgow G12 0YN, United Kingdom

Recruiting
Site contact (verified)

Sarah Cannon Research Institute

London W1G 6AD, United Kingdom

Recruiting
Site contact (verified)

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting

Northern Centre for Cancer Care

Newcastle NE7 7DN, United Kingdom

Recruiting

Churchill Hospital

Oxford OX3 7LE, United Kingdom

COMPLETED

How to Get in Touch

Nurix Therapeutics Patient Outreach

Sponsor contact

CONTACT

4152307815 nx1607101@nurixtx.com
Data sourced from ClinicalTrials.gov · Last verified: 2025-09