[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07318805":3,"trial-entities:NCT07318805":279,"trial-summary:NCT07318805":285},{"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":24,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":90,"secondary_outcomes":106,"sex":153,"minimum_age":154,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":155,"std_ages":174,"locations":177,"central_contacts":265,"overall_officials":271,"references":274,"see_also_links":275},"NCT07318805","C6321001","A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors","A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-08032562 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS","RECRUITING","2030-04-14","2026-07","2026-07-22","2025-12-23","Pfizer","INDUSTRY",false,"The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer. This study also aims to find the best amount of study medication.\n\nThis study is seeking participants that have advanced or metastatic breast cancer (BC), or advanced or metastatic colorectal cancer (CRC).\n\nAll participants in this study will take the study medication (PF-08032562) as pill by mouth. This will be repeated for 28-day cycles.\n\nDepending on which part of the study participants are enrolled into, they will receive the study medication PF-08032562 alone or in combination with other anti-cancer medications. The study medication (PF-08032562) will be taken by mouth (PO) in combination with other anti-cancer medications given in the study clinic by intramuscular (IM) injection into the muscle or intravenous (IV) infusion that is directly injected into the veins at different times (depending on the treatment) during the 28-day cycle. The study may also test different schedules.",null,[19,20,21,22,23],"Advanced Breast Cancer","Metastatic Breast Cancer (HR+\u002F HER2-)","Colorectal Cancer","Metastatic Colorectal Adenocarcinoma","Triple Negative Breast Cancer",[25,26,27,23,28],"Carcinoma, Breast","Estrogen Receptor Positive Breast Cancer","HER2- Breast Cancer","Colon Cancer","INTERVENTIONAL","TREATMENT",[32],"PHASE1",{"count":34,"type":35},260,"ESTIMATED",[37,49,55,62,69,75,83],{"type":38,"name":39,"description":40,"armGroupLabels":41},"DRUG","PF-08032562","Taken by mouth (PO)",[42,43,44,45,46,47,48],"Part 1 Dose Escalation Cohort 1A","Part 1 Dose Escalation Cohort 1B","Part 1 Dose Escalation Cohort 1C","Part 1 Dose Escalation Cohort 1D","Part 2 Dose Expansion Cohort 2A","Part 2 Dose Expansion Cohort 2B","Part 2 Dose Expansion Cohort 2C",{"type":38,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Fulvestrant","Selective Estrogen Receptor Degrader (SERD)",[43,46],[54],"Faslodex",{"type":38,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Cetuximab","Monoclonal antibody (EGFR inhibitor)",[44,47],[60,61],"Erbitux","Enlituo",{"type":38,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"Fluorouracil","Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)",[45,48],[67,68],"5-FU","5-Fluorouracil",{"type":38,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"Oxaliplatin","Part of FOLFOX chemotherapy regimen platinum based compound (alkylating agent)",[45,48],[74],"Eloxatin",{"type":38,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"Leucovorin","Part of FOLFOX chemotherapy regimen (folic acid analog)",[45,48],[80,81,82],"Folinic Acid","Wellcovorin","Calcium Folinate",{"type":38,"name":84,"description":85,"armGroupLabels":86,"otherNames":87},"Bevacizumab","Monoclonal antibody (VEG-F inhibitor)",[45,48],[88,89],"Zirabev","Avastin",[91,95,99,102],{"measure":92,"description":93,"timeFrame":94},"Part 1 (Dose Escalation): Number of participants with Dose-Limiting Toxicities (DLT)","Any adverse events that are attributable to one, the other, or both study treatments, occurring in the DLT observation period are considered DLTs, excluding toxicities clearly due to underlying disease or extraneous causes.","Baseline up to 28 days",{"measure":96,"description":97,"timeFrame":98},"Part 1 (Dose Escalation): Number of participants with laboratory abnormalities","Number of participants with laboratory test abnormalities.","From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first",{"measure":100,"description":101,"timeFrame":98},"Part 1 (Dose Escalation): Incidence of Adverse Events (AEs)","An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.",{"measure":103,"description":104,"timeFrame":105},"Part 2 (Dose Expansion): Objective Response Rate (ORR)","ORR defined as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).","Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years)",[107,111,113,115,118,121,124,127,129,131,134,137,140,143,146,149],{"measure":108,"description":109,"timeFrame":110},"Part 1 & Part 2: Maximum Observed Serum Concentration (Cmax)","Evaluate the single and multiple dose PK of PF-08032562 as monotherapy, or in combination with other anti-tumor agents.","Baseline through end of Cycle 1 (each cycle is 28 days)",{"measure":112,"description":109,"timeFrame":110},"Part 1 & Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax)",{"measure":114,"description":109,"timeFrame":110},"Part 1: Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration (AUClast)",{"measure":116,"description":117,"timeFrame":110},"Part 1: Effect of Food on Cmax","Evaluate the effect of food on Cmax of PF-08032562 as monotherapy",{"measure":119,"description":120,"timeFrame":110},"Part 1: Effect of Food on Tmax","Evaluate the effect of food on Tmax of PF-08032562 as monotherapy",{"measure":122,"description":123,"timeFrame":110},"Part 1: Effect of Food on AUClast","Evaluate the effect of food on AUClast of PF-08032562 as monotherapy",{"measure":125,"description":126,"timeFrame":110},"Part 1: Percent change of immune cells within tumors based on immunohistochemistry assessment","Evaluate the single and multiple dose pharmacodynamics of PF-08032562 as monotherapy, or in combination with other anti-tumor agents. This measure will assess change in the concentration of immune cell-related cytokines and chemokines as potential pharmacodynamic effects of PF-08032562 using Immunohistochemistry (IHC) assays.",{"measure":128,"description":97,"timeFrame":98},"Part 2 (Dose Expansion): Number of participants with laboratory abnormalities",{"measure":130,"description":101,"timeFrame":98},"Part 2 (Dose Expansion): Incidence of Adverse Events (AEs)",{"measure":132,"description":133,"timeFrame":105},"Part 1 & Part 2: Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)","ORR is defined as the percentage of participants in the analysis population having a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1.",{"measure":135,"description":136,"timeFrame":105},"Part 1 & Part 2: Disease Control Rate (DCR) as per RECIST v1.1","DCR is defined as the proportion of participants with CR or PR with confirmation, or Stable Disease (SD) per RECIST version 1.1.",{"measure":138,"description":139,"timeFrame":105},"Part 1 & Part 2: Clinical Benefit Rate (CBR) as per RECIST v1.1","CBR is defined as the percentage of participants with a best overall response of CR or PR at any time before Progressive Disease (PD), or non-CR\u002Fnon-PD or SD for at least 24 weeks from start date of treatment and prior to PD, relative to the appropriate analysis set.",{"measure":141,"description":142,"timeFrame":105},"Part 1 & Part 2: Duration of Response (DOR) as per RECIST v1.1","DOR is defined as the time from first documentation of CR or PR to date of first documentation of PD or death due to any cause.",{"measure":144,"description":145,"timeFrame":105},"Part 1 & Part 2: Progression-Free Survival (PFS) as per RECIST v1.1","PFS is defined as time from start date of treatment to the date of first documentation of PD or death due to any cause.",{"measure":147,"description":148,"timeFrame":105},"Part 1 & Part 2: Time to Response (TTR) as per RECIST v1.1","TTR is defined as the time from start date of treatment to first documentation of CR or PR.",{"measure":150,"description":151,"timeFrame":152},"Part 2: Overall Survival (OS)","OS is defined as time from from start date of treatment to the date of death due to any cause","Up to approximately 2 years","ALL","18 Years",{"inclusion":156,"exclusion":161,"raw_text":173},[157,158,159,160],"18 years of age or older","Advanced or metastatic cancer of the breast or colon Part 1A: metastatic or advanced breast cancer or colorectal cancer for which no standard therapy is available Part 1B: metastatic or advanced breast cancer with disease progression after at least 1 line of treatment with an endocrine therapy and CDK4\u002F6 inhibitor in the advanced or metastatic setting Part 1C: metastatic or advanced colorectal cancer with at least having received chemotherapy and\u002For targeted therapy if appropriate Part 1D: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease Part 2A: metastatic or advanced breast cancer with disease progression after at least 1 prior line of CDK4\u002F6 inhibitor and at least 1 prior line of endocrine therapy Part 2B: metastatic or advanced colorectal cancer with at least having received chemotherapy and\u002For targeted therapy if appropriate Part 2C: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease","Measurable disease","ECOG performance status 0 or 1",[162,163,164,165,166,167,168,169,170,171,172],"Active malignancy within 3 years prior to enrollment","Known symptomatic brain metastases requiring steroids","Advanced\u002Fmetastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term","Prior irradiation to \\>25% of the bone marrow","Hypertension that cannot be controlled by optimal medical therapy","Renal impairment","Hepatic dysfunction","Cardiac abnormalities","Active bleeding disorder","Active or history of clinically significant GI disease","Other unacceptable abnormalities as defined by protocol","Inclusion Criteria:\n\n* 18 years of age or older\n* Advanced or metastatic cancer of the breast or colon Part 1A: metastatic or advanced breast cancer or colorectal cancer for which no standard therapy is available Part 1B: metastatic or advanced breast cancer with disease progression after at least 1 line of treatment with an endocrine therapy and CDK4\u002F6 inhibitor in the advanced or metastatic setting Part 1C: metastatic or advanced colorectal cancer with at least having received chemotherapy and\u002For targeted therapy if appropriate Part 1D: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease Part 2A: metastatic or advanced breast cancer with disease progression after at least 1 prior line of CDK4\u002F6 inhibitor and at least 1 prior line of endocrine therapy Part 2B: metastatic or advanced colorectal cancer with at least having received chemotherapy and\u002For targeted therapy if appropriate Part 2C: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease\n* Measurable disease\n* ECOG performance status 0 or 1\n\nExclusion Criteria:\n\n* Active malignancy within 3 years prior to enrollment\n* Known symptomatic brain metastases requiring steroids\n* Advanced\u002Fmetastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term\n* Prior irradiation to \\>25% of the bone marrow\n* Hypertension that cannot be controlled by optimal medical therapy\n* Renal impairment\n* Hepatic dysfunction\n* Cardiac abnormalities\n* Active bleeding disorder\n* Active or history of clinically significant GI disease\n* Other unacceptable abnormalities as defined by protocol",[175,176],"ADULT","OLDER_ADULT",[178,187,195,203,209,213,217,225,232,236,243,250,257],{"facility":179,"status":8,"city":180,"state":181,"zip":182,"country":183,"geoPoint":184},"City of Hope (City of Hope National Medical Center, City of Hope Medical Center)","Duarte","California","91010","United States",{"lat":185,"lon":186},34.13945,-117.97729,{"facility":188,"status":8,"city":189,"state":190,"zip":191,"country":183,"geoPoint":192},"START Midwest, LLC","Grand Rapids","Michigan","49546",{"lat":193,"lon":194},42.96336,-85.66809,{"facility":196,"status":8,"city":197,"state":198,"zip":199,"country":183,"geoPoint":200},"Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy","Long Island City","New York","11101",{"lat":201,"lon":202},40.74482,-73.94875,{"facility":204,"status":8,"city":198,"state":198,"zip":205,"country":183,"geoPoint":206},"Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).","10021",{"lat":207,"lon":208},40.71427,-74.00597,{"facility":210,"status":8,"city":198,"state":198,"zip":211,"country":183,"geoPoint":212},"Memorial Sloan Kettering Cancer Center 53rd street.","10022",{"lat":207,"lon":208},{"facility":214,"status":8,"city":198,"state":198,"zip":215,"country":183,"geoPoint":216},"Memorial Sloan Kettering Cancer Center - Main Campus","10065",{"lat":207,"lon":208},{"facility":218,"status":8,"city":219,"state":220,"zip":221,"country":183,"geoPoint":222},"The University of Texas MD Anderson Cancer Center - Conroe","Conroe","Texas","77384",{"lat":223,"lon":224},30.31188,-95.45605,{"facility":226,"status":8,"city":227,"state":220,"zip":228,"country":183,"geoPoint":229},"The University of Texas - M.D. Anderson Cancer Center","Houston","77030",{"lat":230,"lon":231},29.76328,-95.36327,{"facility":233,"status":8,"city":227,"state":220,"zip":234,"country":183,"geoPoint":235},"The University of Texas, MD Anderson Cancer Center - West Houston","77079",{"lat":230,"lon":231},{"facility":237,"status":8,"city":238,"state":220,"zip":239,"country":183,"geoPoint":240},"The University of Texas, MD Anderson Cancer Center - League City","League City","77573",{"lat":241,"lon":242},29.50745,-95.09493,{"facility":244,"status":8,"city":245,"state":220,"zip":246,"country":183,"geoPoint":247},"START San Antonio","San Antonio","78229",{"lat":248,"lon":249},29.42412,-98.49363,{"facility":251,"status":8,"city":252,"state":220,"zip":253,"country":183,"geoPoint":254},"The University of Texas, MD Anderson Cancer Center - Sugar Land","Sugar Land","77478",{"lat":255,"lon":256},29.61968,-95.63495,{"facility":258,"status":8,"city":259,"state":260,"zip":261,"country":183,"geoPoint":262},"START Mountain Region","West Valley City","Utah","84119",{"lat":263,"lon":264},40.69161,-112.00105,[266],{"name":267,"role":268,"phone":269,"email":270},"Pfizer CT.gov Call Center","CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[272],{"name":267,"affiliation":13,"role":273},"STUDY_DIRECTOR",[],[276],{"label":277,"url":278},"To obtain contact information for a study center near you, click here.","https:\u002F\u002Fpmiform.com\u002Fclinical-trial-info-request?StudyID=C6321001",{"nct_id":4,"conditions":280,"biomarkers":284},[281,282,283],"Breast Carcinoma","Colorectal Carcinoma","Solid Neoplasm",[],{"nct_id":4,"found":286,"summary":287,"prompt_version":17},true,{"design":288,"status":289,"heading":290,"summary":291,"follow_up":292,"word_count":293,"commitments":294,"compensation":295,"drugs_mentioned":296},"This interventional study plans to enroll 260 participants. It is designed to learn about the safety and effects of PF-08032562 alone or with other anti-cancer therapies.","completed","A Study of PF-08032562 for Advanced or Metastatic Solid Tumors","This study is looking into a medicine called PF-08032562 for people with advanced or metastatic (spread to other parts of the body) breast cancer or colorectal cancer. The goal is to learn how safe PF-08032562 is and how well it works, both on its own and when given with other cancer treatments like Fulvestrant, Cetuximab, or a combination of Fluorouracil and Oxaliplatin (FOLFOX). Researchers also want to find the best dose of PF-08032562. You would take PF-08032562 by mouth in 28-day cycles. The study is currently enrolling participants aged 18 and older.","Safety will be monitored for up to 30 days after your last dose of study treatment or until a new anti-cancer therapy begins, whichever comes first.",92,"You would take the study medication PF-08032562 by mouth in 28-day cycles. Depending on the study part, you may also receive other anti-cancer medications.","Not stated in the trial record.",[39,50,56,63,70]]