[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07540572":3,"trial-entities:NCT07540572":296,"trial-summary:NCT07540572":307},{"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":23,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":46,"secondary_outcomes":71,"sex":126,"minimum_age":127,"maximum_age":128,"healthy_volunteers":129,"eligibility_criteria":130,"std_ages":152,"locations":155,"central_contacts":288,"overall_officials":293,"references":294,"see_also_links":295},"NCT07540572","IDE574-001","A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors","An Open Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of IDE574 as Monotherapy in Locally Advanced or Metastatic Solid Tumors and as Combination Therapy With Fulvestrant in Locally Advanced or Metastatic ER+, HER2- Breast Cancer","RECRUITING","2030-06-30","2026-05","2026-06-16","2026-03-17","IDEAYA Biosciences","INDUSTRY",true,"IDE574 is a synthetically manufactured small molecule inhibitor that co-targets the lysine acetyltransferase enzymes KAT6 and KAT7.\n\nThe purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of IDE574 as monotherapy in participants with locally advanced or metastatic solid tumors and as combination therapy with fulvestrant in participants with advanced or metastatic ER+, HER2- breast cancer.","Part 1 - Monotherapy Dose Escalation and Expansion:\n\nPart 1A - Monotherapy Dose Escalation Part 1A will evaluate increasing doses of IDE574 to assess safety, tolerability and to determine dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) or the recommended dose for expansion (RDE) in subjects with advanced or metastatic ER+, HER2- breast cancer, non-small cell lung cancer, castration-resistant prostate cancer and microsatellite-stable colorectal cancer.\n\nPart 1B - Monotherapy Dose Expansion Part 1B will evaluate in ER+ HER2- advanced or metastatic breast cancer at the potential dose level(s) determined to be safe and tolerable during monotherapy dose escalation Part 1A. In parallel, a basket cohort may be enrolled at or below the highest safe dose level(s) determined to be safe and tolerable in Part 1A.\n\nPart 2 - Combination Dose Escalation and Expansion\n\nPart 2A - IDE574 Combination Therapy with Fulvestrant Dose Escalation Part 2A will evaluate participants with ER+ HER2- advanced or metastatic breast cancer with escalating doses of IDE574 in combination with fulvestrant to assess safety, tolerability and to determine DLTs, MTD or RDE.\n\nPart 2B - IDE574 Combination Therapy with Fulvestrant Dose Expansion Part 2B will be evaluated in ER+ HER2- advanced or metastatic breast cancer at the potential dose level(s) determined to be safe and tolerable during combination dose escalation Part 2A.",[19,20,21,22],"ER+, HER 2- Breast Cancer","Non-small Cell Lung Cancer (NSCLC)","Castration-resistant Prostate Cancer (CRPC)","Microsatellite Stable (MSS) Colorectal Carcinoma",[19,20,21,22,24,25],"KAT6A\u002FB","KAT7","INTERVENTIONAL","TREATMENT",[29],"PHASE1",{"count":31,"type":32},160,"ESTIMATED",[34,42],{"type":35,"name":36,"description":36,"armGroupLabels":37},"DRUG","IDE574",[38,39,40,41],"Combination Dose Escalation (Part 2A) IDE574 + Fulvestrant","Combination Dose Expansion (Part 2B)","Monotherapy Dose Escalation (Part 1A)","Monotherapy Dose Expansion (Part 1B)",{"type":35,"name":43,"description":44,"armGroupLabels":45},"Fulvestrant injection","Fulvestrant Injection",[38,39],[47,51,55,58,61,64,66,69],{"measure":48,"description":49,"timeFrame":50},"Safety and Tolerability of IDE574 in Part 1 A Monotherapy Dose escalation","incidence of DLT; incidence and severity of AEs\u002Fserious adverse events (SAEs) graded based on CTCAE V6.0","21 days following the first dose of IDE574",{"measure":52,"description":53,"timeFrame":54},"Safety and Tolerability of IDE574 in Part 1B Monotherapy Dose expansion based on incidence and severity of AEs\u002FSAEs","Incidence and severity of AEs\u002FSAEs graded based on CTCAE V6.0","Approximately 24 months total study duration",{"measure":56,"description":57,"timeFrame":54},"To evaluate anti-tumor activity of IDE574 of IDE574 in Part 1B Monotherapy Dose expansion based on the ORR per RECIST version 1.1","Objective Response Rate (ORR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response",{"measure":59,"description":60,"timeFrame":54},"To evaluate anti-tumor activity of IDE574 of IDE574 in Part 1B Monotherapy Dose expansion based on DOR per RECIST version 1.1.","Duration of response (DOR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response",{"measure":62,"description":63,"timeFrame":54},"Safety and tolerability of IDE574 in combination with Fulvestrant in Part 2A Combination Dose Escalation based on incidence of DLT","Incidence of DLT; incidence and severity of AEs\u002FSAEs graded based on CTCAE V6.0",{"measure":65,"description":53,"timeFrame":54},"Safety and tolerability of IDE574 in combination with Fulvestrant in Part 2B Combination Dose Expansion based on the incidence and severity of AEs\u002FSAEs",{"measure":67,"description":57,"timeFrame":68},"Anti-tumor activity of IDE574 in combination with Fulvestrant in Part 2B Combination Dose Expansion based on the ORR per RECIST version 1.1","Time Frame: Approximately 24 months total study duration",{"measure":70,"description":60,"timeFrame":68},"Anti-tumor activity of IDE574 in combination with Fulvestrant in Part 2B Combination Dose Expansion based on DOR per RECIST version 1.1.",[72,74,76,79,82,85,87,89,91,93,95,96,97,98,99,102,104,106,109,111,113,114,115,117,118,120,122,123,124,125],{"measure":73,"description":57,"timeFrame":54},"Evaluate the preliminary antitumor activity of IDE574 in Part 1A Monotherapy Dose Escalation based on the ORR per RECIST version 1.1",{"measure":75,"description":60,"timeFrame":54},"Evaluate the preliminary antitumor activity of IDE574 in Part 1A Monotherapy Dose Escalation based on DOR per RECIST version 1.1.",{"measure":77,"description":78,"timeFrame":54},"Evaluate the preliminary antitumor activity of IDE574 in Part 1A Monotherapy Dose Escalation based on Clinical Benefit Rate (CBR)","CBR will be assessed based on the proportion of participants with a Best Overall Response (BOR) of CR, PR or SD lasting for 24 weeks per RECIST version 1.1 from the first dose.",{"measure":80,"description":81,"timeFrame":54},"Evaluate the preliminary antitumor activity of IDE574 in Part 1A Monotherapy Dose Escalation based on Disease control rate","Disease Control Rate (DCR) is the proportion of participants with a BOR of CR, PR, and SD lasting for at least 6 weeks (± 7 days) from the first dose per RECIST version 1.1",{"measure":83,"description":84,"timeFrame":54},"Evaluate the pharmacokinetics (PK) of IDE574 in Part 1A Monotherapy Dose Escalation","Area under concentration time curve from time 0 to the last quantifiable concentration (AUClast)",{"measure":83,"description":86,"timeFrame":54},"Area under concentration time curve from time 0 to the end of dosing interval (AUCtau)",{"measure":83,"description":88,"timeFrame":54},"Maximum observed concentration (Cmax)",{"measure":83,"description":90,"timeFrame":54},"Time to maximum observed concentration (Tmax)",{"measure":83,"description":92,"timeFrame":54},"Concentration observed immediately prior to the next dose (Ctrough)",{"measure":94,"description":84,"timeFrame":54},"Evaluate the PK of IDE574 in Part 1B Monotherapy Dose Expansion",{"measure":94,"description":86,"timeFrame":54},{"measure":94,"description":88,"timeFrame":54},{"measure":94,"description":90,"timeFrame":54},{"measure":94,"description":92,"timeFrame":54},{"measure":100,"description":101,"timeFrame":54},"Evaluate antitumor activity of IDE574 in Part 1B Monotherapy Dose Expansion based on CBR for ER+, HER2- breast cancer","CBR will be assessed based on the proportion of participants with a Best Overall Response (BOR) of CR, PR or SD lasting for 24 weeks per RECIST version 1.1 from the first dose",{"measure":103,"description":81,"timeFrame":54},"Evaluate antitumor activity of IDE574 in Part 1B Monotherapy Dose Expansion based on DCR for other solid tumor types",{"measure":105,"description":57,"timeFrame":54},"Evaluate the preliminary antitumor activity of IDE574 in combination with Fulvestrant Part 2A Combination Dose Escalation based on ORR per RECIST version 1.1",{"measure":107,"description":108,"timeFrame":54},"Evaluate the preliminary antitumor activity of IDE574 in combination with Fulvestrant Part 2A Combination Dose Escalation based on DOR per RECIST version 1.1","uration of response (DOR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response",{"measure":110,"description":78,"timeFrame":54},"Evaluate the preliminary antitumor activity of IDE574 in combination with Fulvestrant Part 2A Combination Dose Escalation based on CBR per RECIST version 1.1",{"measure":112,"description":84,"timeFrame":54},"Evaluate the PK of IDE574 in Part 2A Combination Dose Escalation",{"measure":112,"description":86,"timeFrame":54},{"measure":112,"description":88,"timeFrame":54},{"measure":112,"description":116,"timeFrame":54},"Time to maximum observed concentration (Tmax",{"measure":112,"description":92,"timeFrame":54},{"measure":119,"description":78,"timeFrame":54},"Evaluate antitumor activity of IDE574 in combination with Fulvestrant in Part 2B Combination Dose Expansion based on CBR per RECIST version 1.1",{"measure":121,"description":84,"timeFrame":54},"Evaluate the PK of IDE574 in Part 2B Combination Dose Expansion",{"measure":121,"description":86,"timeFrame":54},{"measure":121,"description":88,"timeFrame":54},{"measure":121,"description":90,"timeFrame":54},{"measure":121,"description":92,"timeFrame":54},"ALL","18 Years","99 Years",false,{"inclusion":131,"exclusion":141,"raw_text":151},[132,133,134,135,136,137,138,139,140],"Part 1A - Participants with advanced or metastatic ER+, HER2- breast cancer, NSCLC, CRPC, and MSS colorectal adenocarcinoma who have progressed on\u002Fafter at least one line of standard of care therapy or are intolerant to additional effective therapies.","Parts 1B, 2A and 2B: Participants with ER+, HER2- breast cancer who have progressed after at least 1 prior line of treatment with an endocrine therapy and a CDK4\u002F6 inhibitor","Female participants with ER+, HER2- breast cancer considered to be of childbearing potential (or have tubal ligations only) must be willing to undergo medically induced menopause (Parts 2A and B only)","Female participants of nonchildbearing potential with ER+, HER2- breast cancer must meet at least 1 of the following criteria: Age ≥ 60 years or age \\\u003C60 years with absence of menstruation for at least 12 months, or had prior removal of both ovaries","Have Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤1.","Have adequate bone marrow, renal and liver function.","Life expectancy of \\>3 months","Able to safely administer and retain orally administered study treatment","Able to comply with contraceptive\u002Fbarrier requirements",[142,143,144,145,146,147,148,149,150],"Known symptomatic brain metastases or leptomeningeal metastasis","Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose with the exception of adequately treated localized tumor.","Have impairment of GI function or GI disease that may significantly alter the absorption of IDE574.","Have active liver or biliary disease.","Have active, uncontrolled bacterial, fungal, or viral infection","Have clinically significant cardiac abnormalities and\u002For blood clotting events within 6 months before the first dose","If participants had adverse reactions to previous experimental antitumor treatment that have not recovered to Grade ≤ 1","Prior irradiation to \\>25% of the bone marrow.","Known or suspected hypersensitivity to IDE574\u002Fexcipients or components (Parts 1 \\& 2) or fulvestrant\u002Fexcipients or components (Part 2 only)","Inclusion Criteria:\n\nArchival Tissue sample for testing\n\n* Part 1A - Participants with advanced or metastatic ER+, HER2- breast cancer, NSCLC, CRPC, and MSS colorectal adenocarcinoma who have progressed on\u002Fafter at least one line of standard of care therapy or are intolerant to additional effective therapies.\n* Parts 1B, 2A and 2B: Participants with ER+, HER2- breast cancer who have progressed after at least 1 prior line of treatment with an endocrine therapy and a CDK4\u002F6 inhibitor\n* Female participants with ER+, HER2- breast cancer considered to be of childbearing potential (or have tubal ligations only) must be willing to undergo medically induced menopause (Parts 2A and B only)\n* Female participants of nonchildbearing potential with ER+, HER2- breast cancer must meet at least 1 of the following criteria: Age ≥ 60 years or age \\\u003C60 years with absence of menstruation for at least 12 months, or had prior removal of both ovaries\n* Have Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤1.\n* Have adequate bone marrow, renal and liver function.\n* Life expectancy of \\>3 months\n* Able to safely administer and retain orally administered study treatment\n* Able to comply with contraceptive\u002Fbarrier requirements\n\nKey Exclusion Criteria:\n\n* Known symptomatic brain metastases or leptomeningeal metastasis\n* Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose with the exception of adequately treated localized tumor.\n* Have impairment of GI function or GI disease that may significantly alter the absorption of IDE574.\n* Have active liver or biliary disease.\n* Have active, uncontrolled bacterial, fungal, or viral infection\n* Have clinically significant cardiac abnormalities and\u002For blood clotting events within 6 months before the first dose\n* If participants had adverse reactions to previous experimental antitumor treatment that have not recovered to Grade ≤ 1\n* Prior irradiation to \\>25% of the bone marrow.\n* Known or suspected hypersensitivity to IDE574\u002Fexcipients or components (Parts 1 \\& 2) or fulvestrant\u002Fexcipients or components (Part 2 only)",[153,154],"ADULT","OLDER_ADULT",[156,171,184,196,209,221,232,244,256,263,275],{"facility":157,"status":8,"city":158,"state":159,"zip":160,"country":161,"contacts":162,"geoPoint":168},"Florida Clinical Trials Group","Plantation","Florida","33322","United States",[163],{"name":164,"role":165,"phone":166,"email":167},"Harshad Amin","CONTACT","954-915-9991","harshamin@floridactg.com",{"lat":169,"lon":170},26.13421,-80.23184,{"facility":172,"status":8,"city":173,"state":174,"zip":175,"country":161,"contacts":176,"geoPoint":181},"START Astera, LLC","East Brunswick","New Jersey","08816",[177],{"name":178,"role":165,"phone":179,"email":180},"Bruno S Fang","732-426-4750","info@startresearch.com",{"lat":182,"lon":183},40.42788,-74.41598,{"facility":185,"status":8,"city":186,"state":187,"zip":188,"country":161,"contacts":189,"geoPoint":193},"START New York Long Island, LLC","Lake Success","New York","11042",[190],{"name":191,"role":165,"phone":192,"email":180},"Geralinde O'Sullivan Coyne","363-207-5160",{"lat":194,"lon":195},40.77066,-73.71763,{"facility":197,"status":8,"city":198,"state":199,"zip":200,"country":161,"contacts":201,"geoPoint":206},"NEXT Texas LLC - Austin","Austin","Texas","78758",[202],{"name":203,"role":165,"phone":204,"email":205},"Sheena Sahota","737-610-5200","ssahota@nextoncology.com",{"lat":207,"lon":208},30.26715,-97.74306,{"facility":210,"status":8,"city":211,"state":199,"zip":212,"country":161,"contacts":213,"geoPoint":218},"NEXT Texas LLC - Dallas","Dallas","75039",[214],{"name":215,"role":165,"phone":216,"email":217},"Farah Polani","972-893-8800","fpolani@nextoncology.com",{"lat":219,"lon":220},32.78306,-96.80667,{"facility":222,"status":8,"city":223,"state":199,"zip":224,"country":161,"contacts":225,"geoPoint":229},"START Dallas Fort Worth, LLC","Fort Worth","76104",[226],{"name":227,"role":165,"phone":228,"email":180},"Henry Xiong","682-350-3010",{"lat":230,"lon":231},32.72541,-97.32085,{"facility":233,"status":8,"city":234,"state":199,"zip":235,"country":161,"contacts":236,"geoPoint":241},"NEXT Texas LLC - Houston","Houston","77054",[237],{"name":238,"role":165,"phone":239,"email":240},"Jennifer Segar","832-384-7900","jsegar@nextoncology.com",{"lat":242,"lon":243},29.76328,-95.36327,{"facility":245,"status":8,"city":246,"state":199,"zip":247,"country":161,"contacts":248,"geoPoint":253},"NEXT Texas LLC - San Antonio","San Antonio","78229",[249],{"name":250,"role":165,"phone":251,"email":252},"David Sommerhalder","210-580-9500","dsommerhalder@nextoncology.com",{"lat":254,"lon":255},29.42412,-98.49363,{"facility":257,"status":8,"city":246,"state":199,"zip":247,"country":161,"contacts":258,"geoPoint":262},"Start San Antonio, LLC",[259],{"name":260,"role":165,"phone":261,"email":180},"Amita Patnaik","2105935250",{"lat":254,"lon":255},{"facility":264,"status":8,"city":265,"state":266,"zip":267,"country":161,"contacts":268,"geoPoint":272},"START Mountain Region, LLC","West Valley City","Utah","84119",[269],{"name":270,"role":165,"phone":271,"email":180},"William B McKean","1 (801) 907-4750",{"lat":273,"lon":274},40.69161,-112.00105,{"facility":276,"status":8,"city":277,"state":278,"zip":279,"country":161,"contacts":280,"geoPoint":285},"NEXT Virginia","Fairfax","Virginia","22031",[281],{"name":282,"role":165,"phone":283,"email":284},"Mohamad A Salkeni","703-783-4510","msalkeni@nextoncology.com",{"lat":286,"lon":287},38.84622,-77.30637,[289],{"name":290,"role":165,"phone":291,"email":292},"IDEAYA Clinical Trials","+1-855-433-224","IDEAYAClinicalTrials@ideayabio.com",[],[],[],{"nct_id":4,"conditions":297,"biomarkers":303},[298,299,300,301,302],"Breast Carcinoma","Colorectal Carcinoma","Lung Non-Small Cell Carcinoma","Prostate Carcinoma","Solid Neoplasm",[304,305,306],"KAT6A Gene","KAT6B Gene","KAT7 Gene",{"nct_id":4,"found":15,"summary":308,"prompt_version":318},{"design":309,"status":310,"heading":311,"summary":312,"follow_up":313,"word_count":314,"commitments":315,"compensation":316,"drugs_mentioned":317},"This is an interventional study planning to enroll 160 participants. It involves different parts, including testing IDE574 alone and in combination with fulvestrant.","completed","IDE574 for Advanced Solid Tumors","This study is testing a drug called IDE574 in adults aged 18 to 99 with advanced solid tumors, including certain types of breast cancer (ER+, HER2-), non-small cell lung cancer, castration-resistant prostate cancer, and microsatellite stable colorectal cancer. You would have already received at least one standard treatment or be unable to tolerate more. The study will look at how safe IDE574 is, how your body handles it (pharmacokinetics), and if it shows early signs of shrinking tumors (preliminary efficacy). For some breast cancer patients, IDE574 will also be tested in combination with fulvestrant injection. Success will be measured by how safe the treatment is and how many patients see their tumors shrink or stop growing. We don't know the current status of recruitment for this study.","Safety and anti-tumor activity will be measured for approximately 24 months total study duration.",127,"Not specified in the trial record.","Not stated in the trial record.",[36,43],"v2"]