OncoMatch/Clinical Trials/NCT05735080
Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer
Is NCT05735080 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including INX-315 and Fulvestrant for breast cancer.
Treatment: INX-315 · Fulvestrant · Abemaciclib — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Ovarian Cancer
Tumor Agnostic
Biomarker criteria
Required: CCNE1 amplification
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: CDK4/6 inhibitor
progressed following treatment with a CDK4/6 inhibitor
Must have received: standard systemic therapy
progressed after standard systemic therapy
Cannot have received: CDK2/4/6 inhibitor
Have received previous therapy with a CDK2/4/6 inhibitor or CDK2 inhibitor.
Cannot have received: CDK2 inhibitor
Have received previous therapy with a CDK2/4/6 inhibitor or CDK2 inhibitor.
Cannot have received: systemic anti-cancer therapy
Exception: within 28 days or at least 5 half-lives, whichever is less, prior to the first dose of the study drug
Systemic anti-cancer therapy within 28 days or at least 5 half-lives, whichever is less, prior to the first dose of the study drug
Cannot have received: high-dose chemotherapy requiring prior stem cell transplant
Previous high-dose chemotherapy requiring prior stem cell transplant
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L
Kidney function
Estimated glomerular filtration rate (eGFR) of ≥60 mL/min
Liver function
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
Cardiac function
Resting QTcF > 470 msec, a history of prolonged QT syndrome or Torsades de pointes, or a familial history of prolonged QT syndrome [excluded]; Uncontrolled, cardiovascular disease (including hypertension) with or without medication [excluded]
Adequate organ function as demonstrated by the following laboratory values: Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; eGFR ≥60 mL/min; 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. Resting QTcF > 470 msec, a history of prolonged QT syndrome or Torsades de pointes, or a familial history of prolonged QT syndrome [excluded]; Uncontrolled, cardiovascular disease (including hypertension) with or without medication [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Florida Cancer Specialists · Lake Mary, Florida
- Emory Winship Cancer Institute · Atlanta, Georgia
- Georgia Cancer Center at Augusta University · Augusta, Georgia
- Fort Wayne Medical Oncology and Hematology · Fort Wayne, Indiana
- Dana-Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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