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New treatment option for HR+ Breast Cancer
Official title A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT07029399
What this study is testing
What is NKT5097 CDK2/CDK4 dual degrader?
NKT5097 CDK2/CDK4 dual degrader is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hr+ breast cancer.
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
- The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1 amplification). Main questions to answer include: What is the recommended dose for expansion and/or Phase 2, for both monotherapy and in combination with ET What medical issues/symptoms do participants experience when taking NKT5097 as monotherapy as well as in combination with ET
- 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
- Able to provide written informed consent
- Advanced unresectable or metastatic solid tumor (Part 1, 2 \& 3 only)
- Advanced unresectable or metastatic HR+/HER2- breast cancer (Part 4 \& 5 only)
- Refractory to or unable to tolerate existing therapies (Part 1, 2 \& 4 only)
- Measurable or evaluable disease (Part 1, 2, \& 4 only).
You likely can't join if
- Advanced solid tumor that is a candidate for curative treatment
- History of another malignancy except for the following: adequately treated local basal cell or squamous carcinoma of the skin, in situ cervical...
- Not recovered from the effects of prior anticancer therapy
- Clinically significant cardiovascular event, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6...
- Known active CNS metastases and/or carcinomatous meningitis
- Active interstitial lung disease requiring treatment
See the full eligibility criteria
- Able to provide written informed consent
- Advanced unresectable or metastatic solid tumor (Part 1, 2 \& 3 only)
- Advanced unresectable or metastatic HR+/HER2- breast cancer (Part 4 \& 5 only)
- Refractory to or unable to tolerate existing therapies (Part 1, 2 \& 4 only)
- Measurable or evaluable disease (Part 1, 2, \& 4 only).
- Measurable disease (Part 3 \& 5 only)
- Eighteen years of age or older
- ECOG status of 0 or 1
- Adequate organ function
- Patients with female reproductive organs must be surgically sterile, post- menopausal or willing to use effective contraception per protocol
- Patients who are capable of insemination must be willing to use highly effective contraception and to refrain from sperm donation during treatment and for 28 days after the last dose
- Able to swallow oral meds
- Willing to provide tumor tissue
- Advanced solid tumor that is a candidate for curative treatment
- History of another malignancy except for the following: adequately treated local basal cell or squamous carcinoma of the skin, in situ cervical cancer, adequately treated papillary noninvasive bladder cancer, other...
- Not recovered from the effects of prior anticancer therapy
- Clinically significant cardiovascular event, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months
- Known active CNS metastases and/or carcinomatous meningitis
- Active interstitial lung disease requiring treatment
- History of uveitis, retinopathy, or other clinically significant retinal disease
- Major surgery within 30 days of administration of first dose
- Active uncontrolled infectious disease
- Significant liver disease (Child Pugh class B or C)
- Should not have received any prior selective investigational inhibitors or degraders (Part 5 only)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- La Jolla, California, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Sarasota, Florida, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
- Cleveland, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
- Morgantown, West Virginia, United States
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; La Jolla, California, United States; Denver, Colorado, United States; New Haven, Connecticut, United States; Sarasota, Florida, United States; Iowa City, Iowa, United States and 12 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.