[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05735080":3,"trial-entities:NCT05735080":355,"trial-summary:NCT05735080":364},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":28,"study_type":33,"primary_purpose":34,"phases":35,"enrollment_info":38,"interventions":41,"primary_outcomes":63,"secondary_outcomes":81,"sex":107,"minimum_age":108,"maximum_age":109,"healthy_volunteers":15,"eligibility_criteria":110,"std_ages":114,"locations":117,"central_contacts":347,"overall_officials":352,"references":353,"see_also_links":354},"NCT05735080","INX-315-01","Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer","A Phase 1\u002F2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced Cancer","RECRUITING","2027-09","2026-03","2026-04-01","2023-03-28","Incyclix Bio","INDUSTRY",false,"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\u002Fmetastatic cancer, including hormone receptor positive (HR+)\u002FHuman Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer who progressed on a prior cyclin-dependent kinase 4\u002F6 inhibitor (CDK4\u002F6i) 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\u002F6i\\] and fulvestrant \\[a SERD\\] in advanced\u002Fmetastatic breast cancer; dose escalation and expansion).","Study INX-315-01 is a first-in-human, Phase 1\u002F2, open-label, dose escalation and dose-expansion study to evaluate the safety, PK, and preliminary antitumor activity of INX-315 in patients with advanced\u002Fmetastatic cancers. The study will be conducted in 3 parts: Part A (dose escalation and combination therapy) and Part B (ovarian cancer dose expansion) and Part C (breast cancer dose escalation lead-in and expansion).\n\nPart A is the dose-escalation portion of the study to evaluate the safety, tolerability, and PK of INX-315 monotherapy. Dosing decisions will be guided using a Bayesian optimal interval (BOIN) design. Up to 60 patients with recurrent advanced\u002Fmetastatic cancer, including patients with HR+\u002FHER2- breast cancer who progressed on a prior CDK4\u002F6i regimen, and solid tumors, including ovarian cancer with known amplification of CCNE1 are planned to be enrolled in Part A.\n\nDose-limiting toxicities (DLTs) will be assessed during the first treatment cycle, i.e., the first 28 days of treatment (the DLT period). Patients who are evaluable for DLT assessment are those patients who are enrolled, received \\>=80% of the planned study drug doses during the DLT assessment period, and complete the 28-day DLT period.\n\nAdditionally, Part A will have two cohorts that will include INX-315 plus fulvestrant in HR+\u002FHER2- patients who have have had prior treatment with CDK4\u002F6i.\n\nPart B will expand at least two dose levels determined by the SMC. Part B will enroll patients with platinum-refractory or platinum-resistant advanced\u002F metastatic ovarian cancer patients with CCNE1 amplifications. Part B will open for enrollment once the SMC has selected the dose levels to be evaluated from the Part A portion of the study. Part A patients cannot re-join or continue the study in Part B. Approximately 30 patients will be equally randomized to receive one of the dose levels of INX-315.\n\nPart C will be a dose escalation and expansion cohort, patients with HR+\u002FHER2- breast cancer will be enrolled in this cohort. Patients will receive INX-315 along with abemaciclib and fulvestrant. Approximately 50 patients will be enrolled in Part C.",[19,20,21,22,23,24,25,26,27],"Breast Cancer","Breast Cancer Metastatic","Hormone Receptor Positive Tumor","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","Ovarian Cancer","CCNE1 Amplification","Solid Tumor","Advanced Cancer","Metastatic Cancer",[29,30,31,32],"CDK2","CDK4\u002F6i","cyclin dependent kinase 2","CCNE1","INTERVENTIONAL","TREATMENT",[36,37],"PHASE1","PHASE2",{"count":39,"type":40},150,"ESTIMATED",[42,51,57],{"type":43,"name":44,"description":45,"armGroupLabels":46},"DRUG","INX-315","Oral administration",[47,48,49,50],"Part A INX-315 + Fulvestrant","Part A: Dose Escalation","Part B: Ovarian Dose Expansion","Part C: HR+\u002FHER2- BC Dose Expansion",{"type":43,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Fulvestrant","Fulvestrant will be combined with INX-315",[47,50],[56],"Faslodex",{"type":43,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"Abemaciclib","Abemaciclib will be combined with INX-315",[50],[62],"Verzenio",[64,67,70,72,75,77,79],{"measure":65,"timeFrame":66},"Part A and B: Evaluate the incidents of treatment emergent adverse events and laboratory abnormalities in INX-315 monotherapy and in combination with fulvestrant","Up to 12 months",{"measure":68,"timeFrame":69},"Part A: Evaluate the occurrence of dose-limiting toxicities (DLTs) during Cycle 1","28 days",{"measure":71,"timeFrame":66},"Part A: Recommend at least two doses of INX-315 to be evaluated in the expansion phase",{"measure":73,"timeFrame":74},"Part B: Overall response rate (ORR)","Up to 36 months",{"measure":76,"timeFrame":74},"Part B: Selection of Recommended Phase 2 Dose (RP2D)",{"measure":78,"timeFrame":66},"Part C Evaluate the incidents of treatment emergent adverse events and laboratory abnormalities for patients in combination treatment (INX_315+abemaciclib+fulvestrant)",{"measure":80,"timeFrame":66},"Part C - Evaluate the antitumor activity of INX-315 in combination with abemaciclib and fulvestrant",[82,85,87,89,91,93,95,97,99,101,103,105],{"measure":83,"timeFrame":84},"Characterize the maximum plasma concentration (Cmax)","Cycle 1 Day 1 and Day 15",{"measure":86,"timeFrame":84},"Characterize the time to maximum plasma concentration (Tmax)",{"measure":88,"timeFrame":84},"Characterize the Area under the plasma concentration versus time curve from time 0 to the end of the dosing interval (AUC0-24h)",{"measure":90,"timeFrame":84},"Characterize the terminal half-life (t1\u002F2)",{"measure":92,"timeFrame":84},"Characterize the oral clearance (CL\u002FF)",{"measure":94,"timeFrame":74},"Part A: Overall response rate (ORR)",{"measure":96,"timeFrame":74},"Disease control rate (DCR)",{"measure":98,"timeFrame":74},"Progression free survival (PFS)",{"measure":100,"timeFrame":74},"Duration of response (DOR)",{"measure":102,"timeFrame":74},"Time to progression (TTP)",{"measure":104,"timeFrame":74},"Overall survival (OS)",{"measure":106,"timeFrame":66},"Part C Determine recommended dose of INX-315 in combination treatment for further study","ALL","18 Years",null,{"inclusion":111,"exclusion":112,"raw_text":113},[],[],"Inclusion Criteria:\n\n1. Advanced unresectable or metastatic HR+\u002FHER2- BC that has progressed following treatment with a CDK4\u002F6 inhibitor in the adjuvant or advanced\u002Fmetastatic setting.\n2. Advanced\u002F 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\n3. 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\n4. At least one measurable lesion as defined by RECIST v1.1 that has not previously been irradiated\n5. ECOG performance status score of 0 or 1.\n6. Adequate organ function as demonstrated by the following laboratory values:\n\n   1. Hemoglobin ≥ 9.0 g\u002FdL\n   2. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL\n   3. Platelet count ≥ 100 × 10\\^9\u002FL\n   4. Estimated glomerular filtration rate (eGFR) of ≥60 mL\u002Fmin\n   5. Part A and B: 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\n7. Negative pregnancy test\n\nExclusion Criteria:\n\n1. Have received previous therapy with a CDK2\u002F4\u002F6 inhibitor or CDK2 inhibitor.\n2. 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.\n3. Have known intracranial hemorrhage and\u002For bleeding diatheses.\n4. Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.\n5. 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.\n6. Resting QTcF \\> 470 msec, a history of prolonged QT syndrome or Torsades de pointes, or a familial history of prolonged QT syndrome.\n7. Uncontrolled, cardiovascular disease (including hypertension) with or without medication\n8. 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.\n9. Known HIV infection, including AIDS-related illness, or have active, uncontrolled infection (viral, bacterial, or fungal), including tuberculosis, hepatitis B virus, hepatitis C virus, or COVID-19 infection (symptoms and a positive test result).\n10. Requires treatment with a prohibited medication or herbal remedy that cannot be discontinued at least 2 weeks before the start of study drug administration.\n11. Have planned or anticipation of the need for major surgical procedure within 28 days of the first dose of study drug (procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures).\n12. Unwilling or unable to comply with scheduled visits, study drug administration plan, laboratory tests, or other study procedures and study restrictions.\n13. Radical radiotherapy within 28 days prior to study entry or palliative radiotherapy within 2 weeks prior to study entry.\n14. Systemic anti-cancer therapy within 21 days or at least 5 half-lives, whichever is less, prior to the first dose of the study drug\n15. Prior irradiation to \\> 25% of the bone marrow\n16. Previous high-dose chemotherapy requiring prior stem cell transplant\n17. Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry.\n18. Known or suspected hypersensitivity to active ingredient\u002Fexcipients in INX-315 or fulvestrant or abemaciclib.\n19. Known difficulty in swallowing or tolerating oral medications, or conditions which would impair absorption of oral medications such as active inflammatory gastrointestinal disease, uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction\u002Fmotility disorder\u002Factive inflammation, malabsorption syndrome, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.\n20. Has a serious and\u002For uncontrolled pre-existing medical condition(s) that, in the judgment of the Investigator or the Sponsor, would preclude participation in this study (for example but not limited to, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea)",[115,116],"ADULT","OLDER_ADULT",[118,135,146,157,171,185,198,213,224,234,248,262,272,287,294,309,324,337],{"facility":119,"status":8,"city":120,"state":121,"zip":122,"country":123,"contacts":124,"geoPoint":132},"Florida Cancer Specialists","Orlando","Florida","32827","United States",[125,129],{"name":126,"role":127,"email":128},"Julia Rivera Otero","CONTACT","Julia.RiveraOtero@Scri.com",{"name":130,"role":131},"Cesar Perez, MD","PRINCIPAL_INVESTIGATOR",{"lat":133,"lon":134},28.53834,-81.37924,{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":123,"contacts":140,"geoPoint":143},"Emory Winship Cancer Institute","Atlanta","Georgia","30322",[141],{"name":142,"role":131},"Kevin M Kalinsky, MD",{"lat":144,"lon":145},33.749,-84.38798,{"facility":147,"status":8,"city":148,"state":138,"zip":149,"country":123,"contacts":150,"geoPoint":154},"Georgia Cancer Center at Augusta University","Augusta","30912",[151],{"name":152,"role":127,"email":153},"Donna Wheatley","dwheatley@augusta.edu",{"lat":155,"lon":156},33.47097,-81.97484,{"facility":158,"status":8,"city":159,"state":160,"zip":161,"country":123,"contacts":162,"geoPoint":168},"Fort Wayne Medical Oncology and Hematology","Fort Wayne","Indiana","46804",[163,166],{"name":164,"role":127,"email":165},"Andrea Vasquez","andrea.vasquez@aoncology.com",{"name":167,"role":131},"Sunil Babu, MD",{"lat":169,"lon":170},41.1306,-85.12886,{"facility":172,"status":8,"city":173,"state":174,"zip":175,"country":123,"contacts":176,"geoPoint":182},"Dana-Farber Cancer Institute","Boston","Massachusetts","02215",[177,180],{"name":178,"role":127,"email":179},"Meghan Levesque","meghan_levesque@dfci.harvard.edu",{"name":181,"role":131},"Antonio Giordano, MD",{"lat":183,"lon":184},42.35843,-71.05977,{"facility":186,"status":8,"city":187,"state":188,"zip":189,"country":123,"contacts":190,"geoPoint":195},"Karmanos Cancer Institute","Detroit","Michigan","48201",[191],{"name":192,"role":127,"phone":193,"email":194},"Madeline McGinnis","313-576-9380","mcginnism@karmanos.org",{"lat":196,"lon":197},42.33143,-83.04575,{"facility":199,"status":8,"city":200,"state":201,"zip":202,"country":123,"contacts":203,"geoPoint":210},"Roswell Park Cancer Institute","Buffalo","New York","14263",[204,208],{"name":205,"role":127,"phone":206,"email":207},"Ask Roswell","800-767-9355","AskRoswell@RoswellPark.org",{"name":209,"role":131},"Sheheryar Kabraji, MD",{"lat":211,"lon":212},42.88645,-78.87837,{"facility":214,"status":8,"city":215,"state":216,"zip":217,"country":123,"contacts":218,"geoPoint":221},"Levine Cancer Institute (LCI)- Atrium Health","Charlotte","North Carolina","28204",[219],{"name":220,"role":131},"Antoinette Tan, MD",{"lat":222,"lon":223},35.22709,-80.84313,{"facility":225,"status":8,"city":226,"state":216,"zip":227,"country":123,"contacts":228,"geoPoint":231},"Duke Cancer Center\u002F DUMC","Durham","27705",[229],{"name":230,"role":131},"Carey Anders, MD",{"lat":232,"lon":233},35.99403,-78.89862,{"facility":235,"status":8,"city":236,"state":237,"zip":238,"country":123,"contacts":239,"geoPoint":245},"Gabrail Cancer Research Center","Canton","Ohio","44718",[240,243],{"name":241,"role":127,"email":242},"Carrie Smith, RN","csmith@gabrailcancercenter.com",{"name":244,"role":131},"Nashat Gabrail, MD",{"lat":246,"lon":247},40.79895,-81.37845,{"facility":249,"status":8,"city":250,"state":251,"zip":252,"country":123,"contacts":253,"geoPoint":259},"Next Oncology","Dallas","Texas","75039",[254,257],{"name":255,"role":127,"email":256},"Fope Akinwale","fakinwale@nextoncology.com",{"name":258,"role":131},"Michael Song, MD",{"lat":260,"lon":261},32.78306,-96.80667,{"facility":263,"status":8,"city":250,"state":251,"zip":264,"country":123,"contacts":265,"geoPoint":271},"UTSW Medical Center","75390",[266,269],{"name":267,"role":127,"email":268},"Isabel Valenciana","isabel.villobos@utsouthwestern.edu",{"name":270,"role":131},"David Miller, MD",{"lat":260,"lon":261},{"facility":273,"status":274,"city":275,"state":251,"zip":276,"country":123,"contacts":277,"geoPoint":284},"Oncology Consultants","NOT_YET_RECRUITING","Houston","77030",[278,282],{"name":279,"role":127,"phone":280,"email":281},"Site PI","713-600-0913","jpeguero@OncologyConsultants.com",{"name":283,"role":131},"Julio Peguero, MD",{"lat":285,"lon":286},29.76328,-95.36327,{"facility":249,"status":8,"city":275,"state":251,"zip":288,"country":123,"contacts":289,"geoPoint":293},"77054",[290,291],{"name":255,"role":127,"email":256},{"name":292,"role":131},"Jennifer Segar, MD",{"lat":285,"lon":286},{"facility":295,"status":8,"city":296,"state":297,"zip":298,"country":123,"contacts":299,"geoPoint":306},"Northwest Medical Specialties, PLLC","Tacoma","Washington","98405",[300,304],{"name":301,"role":127,"phone":302,"email":303},"Sue Quinsey","253-428-8700","squinsey@nwmsonline.com",{"name":305,"role":131},"Jorge Chaves, MD",{"lat":307,"lon":308},47.25288,-122.44429,{"facility":310,"status":8,"city":311,"state":312,"zip":313,"country":314,"contacts":315,"geoPoint":321},"Peninsula and South Eastern Haematology & Oncology Group","Frankston","Victoria","3199","Australia",[316,319],{"name":317,"role":127,"email":318},"Albert Goikhman","ag@paso.com.au",{"name":320,"role":131},"Vinod Ganju, MD",{"lat":322,"lon":323},-38.14458,145.12291,{"facility":325,"status":8,"city":326,"state":312,"zip":327,"country":314,"contacts":328,"geoPoint":334},"Peter MacCallum Cancer Center","Parkville","3052",[329,332],{"name":330,"role":127,"email":331},"Kim Nayeon","Nayeon.Kim@petermac.org",{"name":333,"role":131},"George Au-Yeung, MD",{"lat":335,"lon":336},-37.78333,144.95,{"facility":338,"status":8,"city":339,"zip":340,"country":314,"contacts":341,"geoPoint":344},"Mater Hospital","South Brisbane","4101",[342],{"name":343,"role":131},"Catherine Shannon, MD",{"lat":345,"lon":346},-27.48034,153.02049,[348],{"name":349,"role":127,"phone":350,"email":351},"Clinical Director","1-919-328-0003","clinicalinfo@incyclixbio.com",[],[],[],{"nct_id":4,"conditions":356,"biomarkers":362},[357,358,359,360,361],"Breast Carcinoma","Fallopian Tube Carcinoma","Malignant Ovarian Neoplasm","Primary Peritoneal Cancer","Solid Neoplasm",[363],"G1\u002FS-Specific Cyclin-E1",{"nct_id":4,"found":365,"summary":366,"prompt_version":376},true,{"design":367,"status":368,"heading":369,"summary":370,"follow_up":371,"word_count":372,"commitments":373,"compensation":374,"drugs_mentioned":375},"This is a Phase 1\u002F2, open-label study, meaning you and your doctors will know what treatment you are receiving. It plans to enroll up to 150 participants.","completed","Study of INX-315 for Advanced Breast and Ovarian Cancers","This study is testing a new oral medication called INX-315 for people with advanced breast cancer (specifically, hormone receptor positive and HER2 negative types that have worsened after prior treatment with a CDK4\u002F6 inhibitor) or advanced ovarian cancer (platinum-resistant or refractory, with a specific genetic change called CCNE-1 amplification). Researchers want to understand how safe INX-315 is, how well your body handles it, and if it can help shrink tumors. INX-315 will be given alone or in combination with other drugs like fulvestrant or abemaciclib. The study will look at side effects and how well the treatment works over time, up to 12 months.","The study will evaluate side effects and laboratory changes for up to 12 months.",104,"Participants will receive INX-315, either alone or with other medications. Dose-limiting toxicities (side effects that are severe enough to limit the dose) will be assessed during the first 28 days of treatment.","Not stated in the trial record.",[44,52,58],"v2"]