[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07602842":3,"trial-entities:NCT07602842":226,"trial-summary:NCT07602842":236},{"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":31,"primary_purpose":32,"phases":33,"enrollment_info":36,"interventions":39,"primary_outcomes":47,"secondary_outcomes":58,"sex":80,"minimum_age":81,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":82,"std_ages":116,"locations":119,"central_contacts":218,"overall_officials":223,"references":224,"see_also_links":225},"NCT07602842","IDP-001-101","A Study of IDP-001 in Advanced or Metastatic Solid Tumors","A Phase 1\u002F2 Open-label Study of IDP-001 in Advanced or Metastatic Squamous Cell Lung Cancer and Other Solid Tumors","RECRUITING","2028-12","2026-07","2026-08-27","2026-07-08","InduPro, Inc.","INDUSTRY",false,"This clinical study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of IDP-001 in participants with advanced or metastatic squamous and non-squamous NSCLC and other squamous cell solid tumors (for example, head and neck, esophageal, cervical, cutaneous).",null,[19,20,21,22,23,24,25,26,27],"Advanced Solid Tumor","Metastatic Solid Tumor","Head and Neck Squamous Cell Carcinoma","Cutaneous Squamous Cell Carcinoma","Squamous Cell Carcinoma of the Cervix","Non Squamous Non Small Cell Lung Cancer","Squamous Cell Carcinoma of the Esophagus","Squamous Cell Carcinoma of the Anus","Squamous Cell Carcinoma",[29,30],"NSCLC","Squamous NSCLC","INTERVENTIONAL","TREATMENT",[34,35],"PHASE1","PHASE2",{"count":37,"type":38},132,"ESTIMATED",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44},"DRUG","IDP-001","IV infusion",[45,46],"Phase 1 Part 1 Dose Escalation","Phase 1 Part 2 Indication Selection",[48,51,54,56],{"measure":49,"timeFrame":50},"Phase 1 Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) during Cycle 1","3 weeks",{"measure":52,"timeFrame":53},"Phase 1 Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Dose Reduction, Dose Interruption, and Dose Discontinuation","Approximately 6 months",{"measure":55,"timeFrame":53},"Phase 1 Part 2: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator",{"measure":57,"timeFrame":53},"Phase 1 Part 2: Duration of Response (DOR) per RECIST Version 1.1 as Assessed by Investigator",[59,61,63,65,67,69,71,73,75,77],{"measure":60,"timeFrame":53},"Area Under the Concentration Time Curve (AUC) of IDP-001",{"measure":62,"timeFrame":53},"Maximum Observed Plasma Concentration (Cmax) of IDP-001",{"measure":64,"timeFrame":53},"Number of Participants with Anti-drug Antibodies (ADAs) in Blood",{"measure":66,"timeFrame":53},"Phase 1 Part 1: ORR per RECIST Version 1.1 as Assessed by Investigator",{"measure":68,"timeFrame":53},"Phase 1 Part 1: DOR per RECIST Version 1.1 as Assessed by Investigator",{"measure":70,"timeFrame":53},"Phase 1 Part 2: Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Dose Reduction, Dose Interruption, and Dose Discontinuation",{"measure":72,"timeFrame":53},"Phase 1 Part 2: Disease Control Rate (DCR) per RECIST Version 1.1 as Assessed by Investigator",{"measure":74,"timeFrame":53},"Phase 1 Part 2: Time to Response (TTR) per RECIST Version 1.1 as Assessed by Investigator",{"measure":76,"timeFrame":53},"Phase 1 Part 2: Progression Free Survival (PFS) per RECIST Version 1.1 as Assessed by Investigator",{"measure":78,"timeFrame":79},"Phase 1 Part 2: Overall Survival (OS)","Approximately 18 months","ALL","18 Years",{"inclusion":83,"exclusion":92,"raw_text":115},[84,85,86,87,88,89,90,91],"Eastern Cooperative Oncology Group (ECOG) performance status of 0-1","Histologically-confirmed advanced, metastatic, or recurrent solid tumors that is not amenable to surgical resection or other approved therapeutic options","Satisfy requirements for prior treatments per tumor type as outlined in the protocol","Measurable disease per RECIST v1.1","Participant willing to provide tumor biopsies","Adequate organ function","Agree to contraception requirements as outlined in the protocol","Life expectancy greater than 12 weeks",[93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114],"Any clinically significant cardiac disease","Any clinically significant corneal disorder","Known, active, and uncontrolled hepatitis B virus (HBV), hepatitis virus (HCV) or human immunodeficiency virus (HIV), or uncontrolled chronic or ongoing infectious requiring intravenous treatment.","Active significant neurologic disorders","Requires home oxygen","Active autoimmune disease","History or active skin disease requiring frequent treatment","History of major immunologic reaction to prior immunoglobulin G-containing agent","Clinically significant ascites or liver disease","Uncontrolled diabetes or diabetic neuropathy","Active bleeding disorders","Participation in a concurrent clinical study in the treatment period","Pregnant or lactating or planning to become pregnant","Known hypersensitivity to IDP-001 or any of its ingredients","Unresolved toxicities from previous anticancer therapy","Has had a seizure prior to Screening","Prior solid organ transplant or allogeneic stem cell transplant","Current endocrinopathy","History of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis","History or interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids","Stroke or transient ischemic attack prior to Screening","Participant has any other condition or illness that, in the opinion of the Investigator, may compromise participant safety, compliance, or interfere with the conduct and evaluation of the current study.","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Histologically-confirmed advanced, metastatic, or recurrent solid tumors that is not amenable to surgical resection or other approved therapeutic options\n* Satisfy requirements for prior treatments per tumor type as outlined in the protocol\n* Measurable disease per RECIST v1.1\n* Participant willing to provide tumor biopsies\n* Adequate organ function\n* Agree to contraception requirements as outlined in the protocol\n* Life expectancy greater than 12 weeks\n\nExclusion Criteria:\n\n* Any clinically significant cardiac disease\n* Any clinically significant corneal disorder\n* Known, active, and uncontrolled hepatitis B virus (HBV), hepatitis virus (HCV) or human immunodeficiency virus (HIV), or uncontrolled chronic or ongoing infectious requiring intravenous treatment.\n* Active significant neurologic disorders\n* Requires home oxygen\n* Active autoimmune disease\n* History or active skin disease requiring frequent treatment\n* History of major immunologic reaction to prior immunoglobulin G-containing agent\n* Clinically significant ascites or liver disease\n* Uncontrolled diabetes or diabetic neuropathy\n* Active bleeding disorders\n* Participation in a concurrent clinical study in the treatment period\n* Pregnant or lactating or planning to become pregnant\n* Known hypersensitivity to IDP-001 or any of its ingredients\n* Unresolved toxicities from previous anticancer therapy\n* Has had a seizure prior to Screening\n* Prior solid organ transplant or allogeneic stem cell transplant\n* Current endocrinopathy\n* History of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis\n* History or interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids\n* Stroke or transient ischemic attack prior to Screening\n* Participant has any other condition or illness that, in the opinion of the Investigator, may compromise participant safety, compliance, or interfere with the conduct and evaluation of the current study.\n\nNote: Other inclusion and exclusion criteria may apply.",[117,118],"ADULT","OLDER_ADULT",[120,136,150,165,181,195,206],{"facility":121,"status":8,"city":122,"state":123,"zip":124,"country":125,"contacts":126,"geoPoint":133},"START Los Angeles","Los Angeles","California","90025","United States",[127,130],{"role":128,"email":129},"CONTACT","hopeteam@startresearch.com",{"name":131,"role":132},"Navid Hafez, M.D.","PRINCIPAL_INVESTIGATOR",{"lat":134,"lon":135},34.05223,-118.24368,{"facility":137,"status":8,"city":138,"state":139,"zip":140,"country":125,"contacts":141,"geoPoint":147},"Florida Cancer Specialists","Sarasota","Florida","34232",[142,145],{"role":128,"phone":143,"email":144},"941-377-9993","clinicaltrials@flcancer.com",{"name":146,"role":132},"Manish Patel, M.D.",{"lat":148,"lon":149},27.33643,-82.53065,{"facility":151,"status":8,"city":152,"state":153,"zip":154,"country":125,"contacts":155,"geoPoint":162},"Community Cancer Center North","Indianapolis","Indiana","46250",[156,160],{"name":157,"role":128,"phone":158,"email":159},"Adam Norris","317-621-3858","anorris@ecommunity.com",{"name":161,"role":132},"Nikhil Shukla, M.D.",{"lat":163,"lon":164},39.76838,-86.15804,{"facility":166,"status":167,"city":168,"state":169,"zip":170,"country":125,"contacts":171,"geoPoint":178},"Hackensack Meridian - John Theurer Cancer Center","NOT_YET_RECRUITING","Edison","New Jersey","08837",[172,176],{"name":173,"role":128,"phone":174,"email":175},"Oncology Clinical Research Referral Office","551-996-1777","OncologyResearchReferral@hmhn.org",{"name":177,"role":132},"Miguel Gonzalez-Velez, M.D.",{"lat":179,"lon":180},40.51872,-74.4121,{"facility":182,"status":8,"city":183,"state":184,"zip":185,"country":125,"contacts":186,"geoPoint":192},"Roswell Park Cancer Institute","Buffalo","New York","14263",[187,190],{"role":128,"phone":188,"email":189},"1-800-767-9355","AskRoswell@RoswellPark.org",{"name":191,"role":132},"Prantesh Jain, M.D.",{"lat":193,"lon":194},42.88645,-78.87837,{"facility":196,"status":8,"city":197,"state":184,"zip":198,"country":125,"contacts":199,"geoPoint":203},"START New York Long Island","Lake Success","11042",[200,201],{"role":128,"email":129},{"name":202,"role":132},"Geraldine O'Sullivan-Coyne, M.D.",{"lat":204,"lon":205},40.77066,-73.71763,{"facility":207,"status":8,"city":208,"state":209,"zip":210,"country":125,"contacts":211,"geoPoint":215},"START Dallas Forth Worth","Fort Worth","Texas","76104",[212,213],{"role":128,"email":129},{"name":214,"role":132},"Salwan Al-Mutar, M.D.",{"lat":216,"lon":217},32.72541,-97.32085,[219],{"name":220,"role":128,"phone":221,"email":222},"InduPro Inc.","617-798-1770","clinicaltrials@induprotx.com",[],[],[],{"nct_id":4,"conditions":227,"biomarkers":235},[228,229,230,21,231,232,233,234,27],"Anal Squamous Cell Carcinoma","Cervical Squamous Cell Carcinoma","Esophageal Squamous Cell Carcinoma","Lung Non-Small Cell Carcinoma","Lung Non-Small Cell Squamous Carcinoma","Skin Squamous Cell Carcinoma","Solid Neoplasm",[],{"nct_id":4,"found":237,"summary":238,"prompt_version":248},true,{"design":239,"status":240,"heading":241,"summary":242,"follow_up":243,"word_count":244,"commitments":245,"compensation":246,"drugs_mentioned":247},"This is an interventional study, meaning participants will receive IDP-001. It plans to enroll about 132 participants.","completed","A Study of IDP-001 for Advanced or Metastatic Solid Tumors","This study is testing a new medicine called IDP-001, given as an IV infusion, for people with advanced or metastatic (spread to other parts of the body) solid tumors. This includes specific types like head and neck, cutaneous (skin), and cervical squamous cell carcinoma. The main goals are to see how safe IDP-001 is, how well your body handles it, and if it can shrink tumors. You might be able to join if you have certain advanced solid tumors that haven't responded to other treatments, are at least 18 years old, and have a good general health status. The study plans to enroll about 132 people, but its current status is unclear.","Safety will be measured for approximately 6 months, and tumor response will also be assessed for approximately 6 months.",112,"Not specified in the trial record.","Not stated in the trial record.",[42],"v2"]