A Study of NX-1607 in Adults With Advanced Malignancies

  • STATUS
    Recruiting
  • End date
    Feb 28, 2025
  • participants needed
    268
  • sponsor
    Nurix Therapeutics, Inc.
Updated on 10 April 2023
systemic therapy
measurable disease
carcinoma
fallopian tube
growth factors

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.

Description

Phase 1a is a dose escalation to 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 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).

Phase 1b will investigate the efficacy of NX-1607 at the dose selected in Phase 1a in up to 8 cohorts of patients with 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
  • Mixed solid tumor cohort indications consisting of patients with MPM, TNBC, locally advanced or metastatic urothelial cancer, cervical cancer, or MSS CRC
  • Diffuse large cell B-cell lymphoma (DLBCL), including patients with Richter transformation (DLBCL-RT)

Details
Condition Ovarian Cancer, Epithelial, Gastric Cancer, GastroEsophageal Junction (GEJ) Cancer, Head and Neck Squamous Cell Carcinoma, 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), Metastatic Urothelial Carcinoma, Cervical Cancer, Colorectal Cancer Metastatic, CLL Transformation, Diffuse Large B Cell Lymphoma (DLBCL), Richter Transformation
Treatment NX-1607
Clinical Study IdentifierNCT05107674
SponsorNurix Therapeutics, Inc.
Last Modified on10 April 2023

Eligibility

Yes No Not Sure

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, 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; metastatic or unresectable melanoma; NSCLC; mCRPC; MPM; TNBC; locally advanced or metastatic urothelial cancer; cervical cancer; MSS CRC; or DLBCL (including DLBCL-RT) (Phase 1b only)
Accessible tumor or lymph node (e.g., DLBCL) for biopsy (Phase 1b only)

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
Psychiatric illness or social situation that would limit compliance with study
requirements
Prior treatment with a CPI (anti-PD-1, PD-L1, CTLA-4, etc.) within 3 weeks prior to the first dose of NX-1607
History of CAR-T therapy within 100 days prior to the first dose of NX-1607. Must have evidence of B-cell recovery if prior CAR-T therapy
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
Patients who experienced Grade 3 or higher irAEs with prior immunotherapy
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
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
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
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) 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
Low-risk prostate cancer with Gleason score < 7 and PSA < 10 ng/mL
Adequately treated Stage I cancer from which the patient is currently in remission and has been in remission for ≥ 2 years
Any other cancer from which the patient has been disease-free for ≥ 2 years
Current active liver disease from any cause, 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
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
Use of systemic corticosteroids (> 20 mg prednisone or equivalent) within 15 days (except for prophylaxis for radio diagnostic contrast reactions), or other immunosuppressive drugs within 30 days, prior to the first dose of NX-1607
eligible
Receipt of an investigational product (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
Myocardial infarction
Any of the following within 6 months prior to the first dose of NX-1607
Unstable angina
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)
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
Use, within 14 days prior to the first dose of NX-1607, or the need for concomitant
treatment with, a potent or moderate inhibitor or inducer of CYP3A4 or a
sensitive substrate of CYP3A4
The need for concomitant treatment with a sensitive substrate of P-gp or BCRP
Clear my responses

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