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New treatment option for Ovarian Cancer, Epithelial
Official title A Study of NX-1607 in Adults With Advanced Malignancies
ClinicalTrials.gov ID: NCT05107674
What this study is testing
What is NX-1607?
NX-1607 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ovarian cancer, epithelial.
Also referred to as Cbl-b Inhibitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Patients with primary refractory EOC defined as patients who do not respond to their first platinum-containing regimen or who relapse less than 6...
- 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)...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- Accessible tumor (for all cohorts) or lymph node (DLBCL only) for biopsy (Phase 1b only). Key
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Chicago, Illinois, United States
- Chapel Hill, North Carolina, United States
- Oklahoma City, Oklahoma, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
- Seattle, Washington, United States
- Sutton, Surrey, United Kingdom
- Cambridge, United Kingdom
- Glasgow, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Newcastle, United Kingdom
- Oxford, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; Chicago, Illinois, United States; Chapel Hill, North Carolina, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.