[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07241039":3,"trial-entities:NCT07241039":224,"trial-summary:NCT07241039":229},{"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":20,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":49,"secondary_outcomes":57,"sex":85,"minimum_age":86,"maximum_age":17,"healthy_volunteers":87,"eligibility_criteria":88,"std_ages":109,"locations":112,"central_contacts":212,"overall_officials":218,"references":222,"see_also_links":223},"NCT07241039","M25-632","A Study to Assess the Adverse Events, Change in Disease Activity, and How Oral ABBV-711 Tablets Move Through the Body as a Monotherapy and in Combination With Intravenously Infused Budigalimab (ABBV-181), in Adults With Advanced Squamous Tumors","A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-711 as a Monotherapy or in Combination With Budigalimab (ABBV-181) in Adult Subjects With Advanced Squamous Tumors","RECRUITING","2030-10","2026-08","2026-08-19","2025-11-20","AbbVie","INDUSTRY",true,"Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-711 as a monotherapy and in combination with budigalimab (ABBV-181) in adults with advanced squamous tumors.\n\nABBV-711 is an investigational drug being developed for the treatment of solid tumors. There are multiple treatment arms in this study. Participants will either receive ABBV-711 as a single agent or in combination with budigalimab (another investigational drug) at different doses. Approximately 220 adult participants will be enrolled in the study across 40 sites worldwide.\n\nIn part 1, oral ABBV-711 tablets will be given in escalating doses alone to participants with squamous (sq) tumors. In part 2 oral ABBV-711 tablets will be given at a selected dose from part 1 to participants with squamous non-small cell lung cancer (sqNSCLC), or head and neck squamous cell carcinoma (HNSCC). In part 3, oral ABBV-711 tablets will be given in escalating doses in combination with intravenously (IV) infused budigalimab to participants with sq tumors. In part 4 oral ABBV-711 tablets will be given at a selected dose from part 3 in combination with IV infused budigalimab to participants with sqNSCLC, or HNSCC. The estimated duration of the study is up to approximately 5 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent questionnaire, medical assessments, blood tests, and scans.",null,[19],"Advanced Squamous Tumors",[19,21,22,23,24,25,26,27],"ABBV-711","ABBV-181","Budigalimab","Head and Neck Squamous Cell Carcinoma","Squamous Non-Small Cell Lung Cancer","sqNSCLC","HNSCC","INTERVENTIONAL","TREATMENT",[31],"PHASE1",{"count":33,"type":34},220,"ESTIMATED",[36,46],{"type":37,"name":21,"description":38,"armGroupLabels":39},"DRUG","Oral Tablet",[40,41,42,43,44,45],"Part 1: ABBV-711 Monotherapy Dose Escalation","Part 2a: ABBV-711 Monotherapy Dose Expansion","Part 2b: ABBV-711 Monotherapy Dose Expansion","Part 3: ABBV-711 + BudigalimabDose Escalation","Part 4a: ABBV-711 Budigalimab Dose Expansion","Part 4b: ABBV-711 Budigalimab Dose Expansion",{"type":37,"name":23,"description":47,"armGroupLabels":48},"Intravenous Infusion",[43,44,45],[50,54],{"measure":51,"description":52,"timeFrame":53},"Number of Participants with Adverse Events (AE)s","An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.","Up to Approximately 5 Years",{"measure":55,"description":56,"timeFrame":53},"Best overall Response (BOR)","BOR is defined as partial response (PR) or better per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.",[58,61,64,67,70,73,76,79,82],{"measure":59,"description":60,"timeFrame":53},"Duration of BOR Response","Duration of response for participants with confirmed PR or better.",{"measure":62,"description":63,"timeFrame":53},"Clinical Benefit Rate (CBR)","CBR is defined as the percentage of participants with BOR of stable disease (SD) or BOR of PR or better per investigator review according to RECIST version 1.1 criteria.",{"measure":65,"description":66,"timeFrame":53},"Progression-free survival (PFS)","PFS is defined as time from first ABBV-711 to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.",{"measure":68,"description":69,"timeFrame":53},"Duration of response (DOR)","DOR is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to RECIST 1.1 or other criteria to disease progression or death of any cause, whichever occurs earlier.",{"measure":71,"description":72,"timeFrame":53},"Overall survival (OS)","OS is defined as time from first ABBV-711 to death due to any cause.",{"measure":74,"description":75,"timeFrame":53},"Area Under the Concentration-Time Curve (AUC) of ABBV-711","Area under the concentration-time curve of ABBV-711.",{"measure":77,"description":78,"timeFrame":53},"Maximum Observed Concentration (Cmax) of ABBV-711","Maximum observed concentration of ABBV-711.",{"measure":80,"description":81,"timeFrame":53},"Time to Cmax (Tmax) of ABBV-711","Time to Cmax of ABBV-711.",{"measure":83,"description":84,"timeFrame":53},"Half-Life (t1\u002F2) of ABBV-711","Half-life of ABBV-711.","ALL","18 Years",false,{"inclusion":89,"exclusion":95,"raw_text":108},[90,91,92,93,94],"Must have progressed on or after standard of care therapy and have no curative therapy available (participants who have refused, are considered ineligible for or are intolerant to standard of care therapy are eligible).","Received programmed cell death protein 1 (PD-1)\u002Fprogrammed cell death ligand 1 (PD-L1) targeted agents are eligible.","Confirmation of available archival tumor tissue (formalin-fixed paraffin-embedded \\[FFPE\\] block or freshly cut slides) or provision of fresh tissue biopsy is required for enrollment in this study for gene expression assessment. If archival tissue requirements cannot be met then the AbbVie therapeutic area Medical Director or designee should be contacted to determine subject eligibility.","For head and neck squamous cell carcinoma (HNSCC) participants enrolled in backfill (Part 1 and 3), subjects must provide consent to paired biopsies which are pretreatment and on treatment fresh tumor biopsies from the same tumor lesion, unless deemed not feasible by the investigator where upon consultation with the Sponsor is required. Paired biopsies are encouraged (when safe and feasible) but not required for subjects with squamous non-small cell lung cancer (sqNSCLC) enrolled in the backfill (Part 1 and 3).","Evaluable and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.",[96,97,98,99,100,101,102,103,104,105,106,107],"Active autoimmune diseases besides vitiligo, type 1 diabetes, hypothyroidism, hypopituitarism and psoriasis (not requiring systemic treatment); history of primary immunodeficiency, bone marrow transplantation, or solid organ transplantation. Active inflammatory bowel disease unfit for trial in the opinion of the investigator, including subjects requiring systemic therapy with biologics or immunosuppressive therapy within the past 2 years.","Treatment with any of the following:","Anti-cancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-711. Palliative radiation therapy for bone, skin or symptomatic metastases with 10 fractions or less is not subject to a washout period.","Radiation therapy for central nervous system metastases within 14 days prior to first dose.","Subject has systemically used known moderate\u002Fstrong inhibitors of cytochrome P450 3A (CYP)3A enzyme isoform subfamily within 14 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of study treatment.","Has systemically used known moderate\u002Fstrong inducers of CYP3A within 14 days prior to the first dose of study treatment.","Requires treatment with known moderate or strong inhibitors or inducers of CYP3A from the first dose of study treatment and for the duration of the study.","Administration or consumption of any of the following within 3 days prior to first dose of study treatment and while on study treatment: grapefruit or grapefruit products, Seville oranges (including marmaladecontaining Seville oranges), and star fruit.","Current or prior use of immunosuppressive medication within 14 days prior to the first dose of the study treatment. The following are exceptions to this criterion:","Intranasal, inhaled, topical steroids or local steroid injections (e.g., intra-articular injection);","Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication);","Systemic corticosteroids at doses not to exceed 10 mg\u002Fday of prednisone or equivalent.","Inclusion Criteria:\n\n* Must have progressed on or after standard of care therapy and have no curative therapy available (participants who have refused, are considered ineligible for or are intolerant to standard of care therapy are eligible).\n* Received programmed cell death protein 1 (PD-1)\u002Fprogrammed cell death ligand 1 (PD-L1) targeted agents are eligible.\n* Confirmation of available archival tumor tissue (formalin-fixed paraffin-embedded \\[FFPE\\] block or freshly cut slides) or provision of fresh tissue biopsy is required for enrollment in this study for gene expression assessment. If archival tissue requirements cannot be met then the AbbVie therapeutic area Medical Director or designee should be contacted to determine subject eligibility.\n* For head and neck squamous cell carcinoma (HNSCC) participants enrolled in backfill (Part 1 and 3), subjects must provide consent to paired biopsies which are pretreatment and on treatment fresh tumor biopsies from the same tumor lesion, unless deemed not feasible by the investigator where upon consultation with the Sponsor is required. Paired biopsies are encouraged (when safe and feasible) but not required for subjects with squamous non-small cell lung cancer (sqNSCLC) enrolled in the backfill (Part 1 and 3).\n* Evaluable and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.\n\nExclusion Criteria:\n\n* Active autoimmune diseases besides vitiligo, type 1 diabetes, hypothyroidism, hypopituitarism and psoriasis (not requiring systemic treatment); history of primary immunodeficiency, bone marrow transplantation, or solid organ transplantation. Active inflammatory bowel disease unfit for trial in the opinion of the investigator, including subjects requiring systemic therapy with biologics or immunosuppressive therapy within the past 2 years.\n* Treatment with any of the following:\n\n  * Anti-cancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-711. Palliative radiation therapy for bone, skin or symptomatic metastases with 10 fractions or less is not subject to a washout period.\n  * Radiation therapy for central nervous system metastases within 14 days prior to first dose.\n* Subject has systemically used known moderate\u002Fstrong inhibitors of cytochrome P450 3A (CYP)3A enzyme isoform subfamily within 14 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of study treatment.\n* Has systemically used known moderate\u002Fstrong inducers of CYP3A within 14 days prior to the first dose of study treatment.\n* Requires treatment with known moderate or strong inhibitors or inducers of CYP3A from the first dose of study treatment and for the duration of the study.\n* Administration or consumption of any of the following within 3 days prior to first dose of study treatment and while on study treatment: grapefruit or grapefruit products, Seville oranges (including marmaladecontaining Seville oranges), and star fruit.\n* Current or prior use of immunosuppressive medication within 14 days prior to the first dose of the study treatment. The following are exceptions to this criterion:\n\n  * Intranasal, inhaled, topical steroids or local steroid injections (e.g., intra-articular injection);\n  * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication);\n  * Systemic corticosteroids at doses not to exceed 10 mg\u002Fday of prednisone or equivalent.",[110,111],"ADULT","OLDER_ADULT",[113,122,129,137,145,153,161,170,178,187,194,201,207],{"facility":114,"status":8,"city":115,"state":116,"zip":117,"country":118,"geoPoint":119},"City Of Hope Comprehensive Cancer Center \u002FID# 276550","Duarte","California","91030","United States",{"lat":120,"lon":121},34.13945,-117.97729,{"facility":123,"status":8,"city":124,"state":116,"zip":125,"country":118,"geoPoint":126},"City of Hope - Orange County Lennar Foundation Cancer Center \u002FID# 278432","Irvine","92618",{"lat":127,"lon":128},33.66946,-117.82311,{"facility":130,"status":8,"city":131,"state":132,"zip":133,"country":118,"geoPoint":134},"University of Chicago Medical Center \u002FID# 276638","Chicago","Illinois","60637",{"lat":135,"lon":136},41.85003,-87.65005,{"facility":138,"status":8,"city":139,"state":140,"zip":141,"country":118,"geoPoint":142},"START Midwest \u002FID# 272505","Grand Rapids","Michigan","49546",{"lat":143,"lon":144},42.96336,-85.66809,{"facility":146,"status":8,"city":147,"state":148,"zip":149,"country":118,"geoPoint":150},"Carolina BioOncology Institute \u002FID# 272380","Huntersville","North Carolina","28078",{"lat":151,"lon":152},35.41069,-80.84285,{"facility":154,"status":8,"city":155,"state":156,"zip":157,"country":118,"geoPoint":158},"Next Oncology Dallas \u002FID# 276659","Irving","Texas","75039",{"lat":159,"lon":160},32.81402,-96.94889,{"facility":162,"status":8,"city":163,"state":164,"zip":165,"country":166,"geoPoint":167},"Princess Margaret Cancer Centre \u002FID# 276852","Toronto","Ontario","M5G 2M9","Canada",{"lat":168,"lon":169},43.70643,-79.39864,{"facility":171,"status":8,"city":172,"state":173,"zip":174,"country":166,"geoPoint":175},"CHUM - Centre hospitalier de l Universite de Montreal \u002FID# 277586","Montreal","Quebec","H2X 0A9",{"lat":176,"lon":177},45.50884,-73.58781,{"facility":179,"status":8,"city":180,"state":181,"zip":182,"country":183,"geoPoint":184},"The Chaim Sheba Medical Center \u002FID# 276798","Ramat Gan","Tel Aviv","5265601","Israel",{"lat":185,"lon":186},32.08227,34.81065,{"facility":188,"status":8,"city":189,"zip":190,"country":183,"geoPoint":191},"Rambam Health Care Campus- Haifa \u002FID# 276799","Haifa","3109601",{"lat":192,"lon":193},32.81303,34.99928,{"facility":195,"status":8,"city":196,"zip":197,"country":183,"geoPoint":198},"Hadassah Medical Center-Hebrew University \u002FID# 276800","Jerusalem","91120",{"lat":199,"lon":200},31.76904,35.21633,{"facility":202,"status":8,"city":203,"state":204,"zip":205,"country":206},"National Cancer Center Hospital East \u002FID# 276585","Kashiwa-shi","Chiba","277-8577","Japan",{"facility":208,"status":8,"city":209,"state":210,"zip":211,"country":206},"Kansai Medical University Hospital \u002FID# 276586","Hirakata-shi","Osaka","573-1191",[213],{"name":214,"role":215,"phone":216,"email":217},"ABBVIE CALL CENTER","CONTACT","844-663-3742","abbvieclinicaltrials@abbvie.com",[219],{"name":220,"affiliation":13,"role":221},"ABBVIE INC.","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":225,"biomarkers":228},[24,226,227],"Lung Non-Small Cell Carcinoma","Squamous Cell Carcinoma",[],{"nct_id":4,"found":15,"summary":230,"prompt_version":240},{"design":231,"status":232,"heading":233,"summary":234,"follow_up":235,"word_count":236,"commitments":237,"compensation":238,"drugs_mentioned":239},"This is an interventional study involving approximately 220 adult participants. It will test ABBV-711 alone and in combination with budigalimab at different doses.","completed","Study of ABBV-711 and Budigalimab for Advanced Squamous Tumors","This study is looking at two investigational drugs, ABBV-711 and budigalimab (ABBV-181), for adults with advanced squamous tumors. These are cancers that have grown or spread. The study wants to see how safe these drugs are, how well your body handles them, and if they can help shrink tumors. You might receive ABBV-711 alone or in combination with budigalimab. You can join if your cancer has progressed after standard treatments, or if you can't have standard treatments. Even if you've had certain immunotherapy (treatments that use your body's immune system to fight cancer) before, you may still be eligible. The study will track side effects and how much your tumors respond to the treatment for up to five years. About 220 adults will participate worldwide.","Participants will be followed for up to approximately 5 years to measure side effects and tumor response.",125,"Not specified in the trial record.","Not stated in the trial record.",[21,23],"v2"]