RecruitingBreast CancerBreast Cancer MetastaticHormone Receptor Positive Tumor

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

Eligible age

18+ yrs

Accepts

All genders

Locations

10 states

Healthy volunteers

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About this study

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).

Sponsor: Incyclix Bio

You may qualify if…

✓ 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

You may not qualify if…

✕ 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.