RecruitingPhase 1 / Phase 2

Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests INX-315, a pill for advanced cancer, alone or with other cancer drugs. It checks safety, how the body handles the drug, and whether it may help fight cancer. It is for people with certain breast cancers or tumors with extra copies of a gene called CCNE1.

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. The study will be conducted in 3 parts: Part A (INX-315 monotherapy dose escalation and combination therapy with fulvestrant), Part B (ovarian cancer INX-315 monotherapy dose expansion), and Part C (INX-315 combination therapy with abemaciclib \[a CDK4/6i\] and fulvestrant \[a SERD\] in advanced/metastatic breast cancer; dose escalation and expansion).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have one of the cancer types listed below, with the required past treatment.
  • Breast cancer that uses hormones to grow and is HER2-negative. It cannot be removed by surgery or has spread, and it got worse after a CDK4/6-blocking drug.
  • Advanced or spreading high-grade serous cancer of the ovary, fallopian tube, or belly lining, with extra CCNE1 gene copies. Platinum drugs no longer work or did not work, and the cancer got worse after standard drug treatment.
  • An advanced or spreading solid tumor with extra CCNE1 gene copies. Standard treatment did not work, caused side effects you could not tolerate, or is not an option.
  • Have at least one tumor that can be measured and has not been treated with radiation.
  • Be fully active or able to do light work despite some limits on hard physical activity.
  • Have blood counts, kidney tests, and liver tests that meet the study's limits.
  • Have a negative pregnancy test.

Who can't join

  • Past treatment with a CDK2-blocking drug or a drug that blocks CDK2, CDK4, and CDK6.
  • Cancer in the brain or spinal cord pressure that causes worsening nerve symptoms or needs recent steroid treatment; bleeding in the skull; or a bleeding disorder.
  • Cancer causing a severe organ crisis, spread through lung lymph channels, or spread to the lining around the brain and spinal cord.
  • Active lung scarring or inflammation, certain heart rhythm problems, uncontrolled heart or blood vessel disease, or another serious uncontrolled illness.
  • HIV or an active, uncontrolled infection. Other past cancers may also exclude you, though some treated cancers are allowed.
  • Recent cancer treatment, radiation, or experimental drugs; past radiation to over one-quarter of the bone marrow; or past high-dose chemotherapy that required a stem cell transplant.
  • Expected major surgery within 28 days of the first dose, a banned drug or herbal remedy that cannot be stopped in time, or inability or unwillingness to follow study visits and rules.
  • Known or suspected allergy to the study drugs, trouble swallowing or tolerating pills, or gut problems that may keep the body from taking in the drugs.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Advanced unresectable or metastatic HR+/HER2- BC that has progressed following treatment with a CDK4/6 inhibitor in the adjuvant or advanced/metastatic setting. 2. 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 standard systemic therapy 3. 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 4. At least one measurable lesion as defined by RECIST v1.1 that has not previously been irradiated 5. ECOG performance status score of 0 or 1. 6. Adequate organ function as demonstrated by the following laboratory values: 1. Hemoglobin ≥ 9.0 g/dL 2. Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L 3. Platelet count ≥ 100 × 10\^9/L 4. Estimated glomerular filtration rate (eGFR) of ≥60 mL/min 5. 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 normal limits 7. Negative pregnancy test Exclusion Criteria: 1. Have received previous therapy with a CDK2/4/6 inhibitor or CDK2 inhibitor. 2. 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. 3. Have known intracranial hemorrhage and/or bleeding diatheses. 4. Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis. 5. 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. 6. Resting QTcF \> 470 msec, a history of prolonged QT syndrome or Torsades de pointes, or a familial history of prolonged QT syndrome. 7. Uncontrolled, cardiovascular disease (including hypertension) with or without medication 8. 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) superficial bladder cancer; or (3) other curatively treated solid tumor with no evidence of disease for ≥ 3 years. 9. 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 and a positive test result). 10. Requires treatment with a prohibited medication or herbal remedy that cannot be discontinued at least 2 weeks before the start of study drug administration. 11. 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 are not considered major surgical procedures). 12. Unwilling or unable to comply with scheduled visits, study drug administration plan, laboratory tests, or other study procedures and study restrictions. 13. Radical radiotherapy within 28 days prior to study entry or palliative radiotherapy within 2 weeks prior to study entry. 14. 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 15. Prior irradiation to \> 25% of the bone marrow 16. Previous high-dose chemotherapy requiring prior stem cell transplant 17. Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry. 18. Known or suspected hypersensitivity to active ingredient/excipients in INX-315 or fulvestrant or abemaciclib. 19. 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., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction/motility disorder/active inflammation, malabsorption syndrome, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery. 20. 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 disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea)

Study sites (15)

FL

GA

IN

MA

MI

NC

  • Levine Cancer Institute (LCI)- Atrium Health · Charlotte, NC 28204Antoinette Tan, MD · Principal investigatorMore trials in Charlotte
  • Duke Cancer Center/ DUMC · Durham, NC 27705Carey Anders, MD · Principal investigatorMore trials in Durham

NY

OH

TX

WA