Actively Recruiting
Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer
Led by Incyclix Bio · Updated on 2026-04-01
150
Participants Needed
18
Research Sites
231 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Advanced unresectable or metastatic HR+/HER2- breast cancer that progressed after CDK4/6 inhibitor treatment
- Advanced or metastatic platinum-resistant or platinum-refractory high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with CCNE1 amplification after standard therapy
- Advanced or metastatic solid tumor with CCNE1 amplification that progressed after standard therapy or is intolerant/ineligible for standard therapy
- At least one measurable lesion not previously irradiated as defined by RECIST v1.1
- ECOG performance status of 0 or 1
- Adequate organ function with hemoglobin ≥ 9.0 g/dL, ANC ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L, eGFR ≥ 60 mL/min
- Total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 2.5 x ULN (≤ 5 x ULN with liver metastases) for Parts A and B; for Part C, total bilirubin ≤ 2.0 x ULN with normal direct bilirubin in patients with Gilbert's syndrome
- Negative pregnancy test
You will not qualify if you...
- Previous therapy with any CDK2/4/6 inhibitor or CDK2 inhibitor
- Presence of CNS metastases or spinal cord compression with worsening neurological symptoms or requiring corticosteroids within 4 weeks
- Known intracranial hemorrhage or bleeding disorders
- Visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
- Active interstitial lung disease or radiation pneumonitis within 28 days prior to treatment
- Resting QTcF > 470 msec, history of prolonged QT syndrome or Torsades de pointes, or family history of prolonged QT syndrome
- Uncontrolled cardiovascular disease, including hypertension
- History of other malignancies except certain treated skin, cervical, prostate, bladder, or other solid tumors without disease for ≥ 3 years
- Known HIV infection or active uncontrolled infections including tuberculosis, hepatitis B or C, or COVID-19
- Use of prohibited medications or herbal remedies that cannot be stopped 2 weeks before treatment
- Planned major surgery within 28 days of first dose
- Inability or unwillingness to comply with study visits, drug administration, or procedures
- Recent radical or palliative radiotherapy or systemic anti-cancer therapy within specified timeframes
- Prior irradiation to > 25% of bone marrow
- Previous high-dose chemotherapy requiring stem cell transplant
- Participation in another investigational drug study within 4 weeks
- Known hypersensitivity to INX-315, fulvestrant, or abemaciclib
- Difficulty swallowing or absorbing oral medications or active gastrointestinal conditions that impair absorption
- Serious uncontrolled pre-existing medical conditions that preclude study participation as judged by investigator or sponsor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Florida Cancer Specialists
Orlando, Florida, United States, 32827
Actively Recruiting
2
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
4
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46804
Actively Recruiting
5
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
7
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
8
Levine Cancer Institute (LCI)- Atrium Health
Charlotte, North Carolina, United States, 28204
Actively Recruiting
9
Duke Cancer Center/ DUMC
Durham, North Carolina, United States, 27705
Actively Recruiting
10
Gabrail Cancer Research Center
Canton, Ohio, United States, 44718
Actively Recruiting
11
Next Oncology
Dallas, Texas, United States, 75039
Actively Recruiting
12
UTSW Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
13
Oncology Consultants
Houston, Texas, United States, 77030
Not Yet Recruiting
14
Next Oncology
Houston, Texas, United States, 77054
Actively Recruiting
15
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States, 98405
Actively Recruiting
16
Peninsula and South Eastern Haematology & Oncology Group
Frankston, Victoria, Australia, 3199
Actively Recruiting
17
Peter MacCallum Cancer Center
Parkville, Victoria, Australia, 3052
Actively Recruiting
18
Mater Hospital
South Brisbane, Australia, 4101
Actively Recruiting
Research Team
C
Clinical Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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