NCT05735080 · Incyclix Bio
Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer
(INX-315-01)
What this study is about
Incyclix Bio (Incyclix) is developing INX-315 as an taken by mouth, small molecule inhibitor of cyclin dependent kinase 2 (CDK2) for the treatment of human cancers.
View original scientific description
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.
Interventions
DRUG
INX-315
Oral administration
DRUG
Fulvestrant
Fulvestrant will be combined with INX-315
DRUG
Abemaciclib
Abemaciclib will be combined with INX-315
Primary outcome measures
Part A and B: Evaluate the incidents of treatment emergent adverse events and laboratory abnormalities in INX-315 monotherapy and in combination with fulvestrant
Time frame: Up to 12 months
Part A: Evaluate the occurrence of dose-limiting toxicities (DLTs) during Cycle 1
Time frame: 28 days
Part A: Recommend at least two doses of INX-315 to be evaluated in the expansion phase
Time frame: Up to 12 months
Part B: Overall response rate (ORR)
Time frame: Up to 36 months
Part B: Selection of Recommended Phase 2 Dose (RP2D)
Time frame: Up to 36 months
Part C Evaluate the incidents of treatment emergent adverse events and laboratory abnormalities for patients in combination treatment (INX_315+abemaciclib+fulvestrant)
Time frame: Up to 12 months
Part C - Evaluate the antitumor activity of INX-315 in combination with abemaciclib and fulvestrant
Time frame: Up to 12 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Advanced unresectable or metastatic ER+/HER2- BC that has progressed following treatment with a CDK4/6 inhibitor 2. Advanced/ metastatic platinum-resistant or platinum-refractory epithelial ovarian cancer (including fallopian tube cancer/primary peritoneal cancer) CCNE-1 amplified tumors 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 × 109/L 3. Platelet count ≥ 100 × 109/L 4. Estimated glomerular filtration rate (eGFR) of ≥60 mL/min 5. Part A and B: Total bilirubin ≤ 1.5 × ULN; AST and ALT ≤
Where
- Orlando, Florida
- Atlanta, Georgia
- Augusta, Georgia
- Fort Wayne, Indiana
- Boston, Massachusetts
- Detroit, Michigan
- Buffalo, New York
- Charlotte, North Carolina
- Durham, North Carolina
- Canton, Ohio
- Dallas, Texas
- Houston, Texas
And 1 more location — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 1, 2026 · Source of record for eligibility and locations