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Tests treatment safety and results for Breast Cancer
Official title Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer
ClinicalTrials.gov ID: NCT05735080
What this study is testing
What is INX-315?
INX-315 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for 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
- Incyclix Bio (Incyclix) is developing INX-315 as an oral, small molecule inhibitor of cyclin dependent kinase 2 (CDK2) for the treatment of human cancers. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity of INX-315 in patients with recurrent advanced/metastatic cancer, including hormone receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer who progressed on a prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) regimen, and CCNE1-amplified solid tumors who progressed on standard of care treatment.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Advanced unresectable or metastatic HR+/HER2- BC that has progressed following treatment with a CDK4/6 inhibitor in the adjuvant or...
- Advanced/ metastatic platinum-resistant or platinum-refractory high grade serous epithelial ovarian cancer, fallopian tube cancer, or primary...
- Advanced or metastatic solid tumor with known amplification of CCNE-1 that has progressed after standard therapy, been intolerant to or is ineligible...
- At least one measurable lesion as defined by RECIST v1.1 that has not previously been irradiated
- ECOG performance status score of 0 or 1.
You likely can't join if
- Have received previous therapy with a CDK2/4/6 inhibitor or CDK2 inhibitor.
- Have central nervous system (CNS) metastases or spinal cord compression that is associated with progressive neurological symptoms or requires...
- Have known intracranial hemorrhage and/or bleeding diatheses.
- Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.
- Have clinically active ongoing interstitial lung disease (ILD) of any etiology, including drug-induced ILD, and radiation pneumonitis within 28 days...
- Resting QTcF \> 470 msec, a history of prolonged QT syndrome or Torsades de pointes, or a familial history of prolonged QT syndrome.
See the full eligibility criteria
- Advanced unresectable or metastatic HR+/HER2- BC that has progressed following treatment with a CDK4/6 inhibitor in the adjuvant or advanced/metastatic setting.
- Advanced/ metastatic platinum-resistant or platinum-refractory high grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, with known amplification of CCNE-1 that progressed after...
- Advanced or metastatic solid tumor with known amplification of CCNE-1 that has progressed after standard therapy, been intolerant to or is ineligible for standard therapy
- At least one measurable lesion as defined by RECIST v1.1 that has not previously been irradiated
- ECOG performance status score of 0 or 1.
- Adequate organ function as demonstrated by the following laboratory values:
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L
- Platelet count ≥ 100 × 10\^9/L
- Estimated glomerular filtration rate (eGFR) of ≥60 mL/min
- Part A and B: Total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN; ≤ 5 × ULN in the presence of liver metastases Part C: Patients with Gilbert's syndrome with a total bilirubin ≤ 2.0 × ULN and direct bilirubin within...
- Negative pregnancy test
- Have received previous therapy with a CDK2/4/6 inhibitor or CDK2 inhibitor.
- Have central nervous system (CNS) metastases or spinal cord compression that is associated with progressive neurological symptoms or requires corticosteroids (within 4 weeks of enrollment) to control the CNS disease.
- Have known intracranial hemorrhage and/or bleeding diatheses.
- Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.
- Have clinically active ongoing interstitial lung disease (ILD) of any etiology, including drug-induced ILD, and radiation pneumonitis within 28 days prior to initiation of study treatment.
- Resting QTcF \> 470 msec, a history of prolonged QT syndrome or Torsades de pointes, or a familial history of prolonged QT syndrome.
- Uncontrolled, cardiovascular disease (including hypertension) with or without medication
- History of other malignancies, except for the following: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c)...
- Known HIV infection, including AIDS-related illness, or have active, uncontrolled infection (viral, bacterial, or fungal), including tuberculosis, hepatitis B virus, hepatitis C virus, or COVID-19 infection (symptoms...
- Requires treatment with a prohibited medication or herbal remedy that cannot be discontinued at least 2 weeks before the start of study drug administration.
- Have planned or anticipation of the need for major surgical procedure within 28 days of the first dose of study drug (procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement...
- Unwilling or unable to comply with scheduled visits, study drug administration plan, laboratory tests, or other study procedures and study restrictions.
- Radical radiotherapy within 28 days prior to study entry or palliative radiotherapy within 2 weeks prior to study entry.
- Systemic anti-cancer therapy within 21 days or at least 5 half-lives, whichever is less, prior to the first dose of the study drug
- Prior irradiation to \> 25% of the bone marrow
- Previous high-dose chemotherapy requiring prior stem cell transplant
- Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry.
- Known or suspected hypersensitivity to active ingredient/excipients in INX-315 or fulvestrant or abemaciclib.
- Known difficulty in swallowing or tolerating oral medications, or conditions which would impair absorption of oral medications such as active inflammatory gastrointestinal disease, uncontrolled nausea or vomiting (i.e...
- Has a serious and/or uncontrolled pre-existing medical condition(s) that, in the judgment of the Investigator or the Sponsor, would preclude participation in this study (for example but not limited to, interstitial lung...
The study team makes the final eligibility decision.
Where it's taking place
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Fort Wayne, Indiana, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Buffalo, New York, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Canton, Ohio, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Tacoma, Washington, United States
- Frankston, Victoria, Australia
- Parkville, Victoria, Australia
- South Brisbane, Australia
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 Orlando, Florida, United States; Atlanta, Georgia, United States; Augusta, Georgia, United States; Fort Wayne, Indiana, United States; Boston, Massachusetts, United States; Detroit, Michigan, United States and 10 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.