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 (Sep 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
Treatments studied
Targeted therapy
Endocrine / hormonal
Other
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 — adjuvant or advanced/metastatic hr+/her2- breast cancer
Must have received: platinum-based chemotherapy — platinum-resistant or platinum-refractory high grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
Must have received: standard systemic therapy — advanced or metastatic solid tumor
Cannot have received: cdk2/4/6 inhibitor
Cannot have received: high-dose chemotherapy requiring prior stem cell transplant
Cannot have received: irradiation to > 25% of the bone marrow
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; gilbert's syndrome: total bilirubin ≤ 2.0 × uln and direct bilirubin within normal limits
Cardiac function
resting qtcf > 470 msec, history of prolonged qt syndrome or torsades de pointes, or 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 · Orlando, 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 →Frequently asked questions
Is NCT05735080 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cdk2/4/6 inhibitor, high-dose chemotherapy requiring prior stem cell transplant, irradiation to > 25% of the bone marrow disqualifies patients from enrollment.
Does this trial require CCNE1?
Yes, CCNE1 amplification is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages