[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07529808":3,"trial-entities:NCT07529808":158,"trial-summary:NCT07529808":166},{"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":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":32,"study_type":36,"primary_purpose":37,"phases":38,"enrollment_info":41,"interventions":44,"primary_outcomes":53,"secondary_outcomes":65,"sex":106,"minimum_age":107,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":108,"std_ages":132,"locations":135,"central_contacts":154,"overall_officials":155,"references":156,"see_also_links":157},"NCT07529808","BHB810-001","Phase 1\u002F2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma","Phase 1\u002F2, Open-Label, Multicenter, Dose Escalation and Expansion Study of BHB810 in Participants With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma","RECRUITING","2028-12","2026-07","2026-07-08","BigHat Biosciences, Inc.","INDUSTRY",false,"This study is looking at how safe BHB810 is in adults with gastric and gastroesophageal adenocarcinoma (GEJ). The purpose of this study is also to look at: how well the study drug works, how the study drug moves into, through, and out of the body, and how your body reacts to the study drug. Participants will get an IV infusion of BHB810 every 2 weeks while on study treatment.",null,[18,19,20,21,22,23,24,25,26,27,28,29,30,31],"Gastric Cancer","Gastric Adenocarcinoma","Gastric (Stomach) Cancer","Gastroesophageal Adenocarcinoma","Gastroesophageal Cancer (GC)","Gastroesophageal Junction (GEJ) Adenocarcinoma","Gastroesophageal Junction (GEJ) Cancer","Gastrointestinal Cancer Metastatic","Gastrointestinal Adenocarcinoma","Gastrointestinal Cancers","Colorectal (Colon or Rectal) Cancer","Pancreatic Cancer","CDH17-positive Advanced Solid Tumors","Advanced Gastric Cancer",[33,34,35],"Antibody Drug Conjugate (ADC)","Monomethyl Auristatin E (MMAE)","CDH17 protein","INTERVENTIONAL","TREATMENT",[39,40],"PHASE1","PHASE2",{"count":42,"type":43},164,"ESTIMATED",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49},"DRUG","BHB810","Every 2 weeks IV administration",[50,51,52],"Dose Escalation and Backfill Cohorts","Recommended Phase 2 Dose Level 1 (RP2D1)","Recommended Phase 2 Dose Level 2 (RP2D2)",[54,58,61],{"measure":55,"description":56,"timeFrame":57},"Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs) per Common Terminology Criteria for Adverse Events v6.0 (CTCAE v6.0)","Investigate the safety and tolerability of BHB810 by evaluation of AEs, SAEs, DLTs, and clinically significant changes safety assessments, like lab tests, vital signs, and other safety assessments\n\nPhase 1 (Dose Escalation \\& Backfill Cohorts) and Phase 2 (Dose Optimization)\n\nDLTs apply to Phase 1 Dose Escalation Cohorts only.","Cycle 1 Day 1 through 30 days after the last dose, an average of 6 months",{"measure":59,"description":60,"timeFrame":57},"Incidence of participants who have a dose modification of BHB810 due to toxicity","Investigate the safety and tolerability of BHB810 by assessment of dose modifications due to toxicity\n\nPhase 1 (Dose Escalation \\& Backfill Cohorts)",{"measure":62,"description":63,"timeFrame":64},"Overall Response Rate (ORR)","Identify the recommended Phase 2 dose (RP2D) by comparing 2 doses of BHB810 by evaluating the ORR of participants according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n\nPhase 2 (Dose Optimization)","Screening through End of Treatment, an average of 6 months",[66,69,73,76,80,84,87,90,92,94,96,98,100,103],{"measure":67,"description":68,"timeFrame":64},"Clinical Benefit Rate (CBR)","Investigate preliminary antitumor activity of BHB810 as assessed by radiological response per RECIST v1.1\n\nNumber of participants who achieve stable disease (SD) for at least 6 months, or PR or CR for any duration\n\nPhase 1 (Dose Escalation \\& Backfill Cohorts)",{"measure":70,"description":71,"timeFrame":72},"Duration of Response (DOR)","Investigate preliminary antitumor activity of BHB810 as assessed by radiological response per RECIST v1.1\n\nTime from PR or CR to disease progression\n\nPhase 1 (Dose Escalation \\& Backfill Cohorts) Phase 2 (Dose Optimization)","Screening through End of Treatment or last scan, an average of 6 months",{"measure":74,"description":75,"timeFrame":64},"Progression Free Survival (PFS)","Investigate preliminary antitumor activity of BHB810 as assessed by radiological response per RECIST v1.1\n\nTime from first dose to first documented date of progression per RECIST v1.1\n\nPhase 1 (Dose Escalation \\& Backfill Cohorts) Phase 2 (Dose Optimization)",{"measure":77,"description":78,"timeFrame":79},"Overall Survival (OS)","Investigate preliminary antitumor activity of BHB810\n\nTime from first dose to death from any cause\n\nPhase 1 (Dose Escalation \\& Backfill Cohorts) Phase 2 (Dose Optimization)","Screening through End of Study, an average of 10 months",{"measure":81,"description":82,"timeFrame":83},"Pharmacokinetics: Area under the concentration-time curve (AUC)","To characterize the PK profile of BHB810 in blood samples\n\nPhase 1 (Dose Escalation \\& Backfill Cohorts)","At protocol defined intervals starting at Cycle 1 Day 1 through End of Treatment, an average of 6 months",{"measure":85,"description":86,"timeFrame":83},"Pharmacokinetics: Area under the concentration-time curve from zero to the end of a dosing interval at steady-state (AUC0-tau)","To characterize the PK profile of BHB810 in blood samples\n\nPhase 1 (Dose Escalation \\& Backfill Cohorts) Phase 2 (Dose Optimization)",{"measure":88,"description":89,"timeFrame":83},"Pharmacokinetics: Maximum concentration of BHB810 (Cmax) Phase 1 (Dose Escalation & Backfill Cohorts) Phase 2 (Dose Optimization)","To characterize the PK profile of BHB810 in blood samples",{"measure":91,"description":86,"timeFrame":83},"Pharmacokinetics: Time to reach maximum drug concentration of BHB810 (Tmax)",{"measure":93,"description":86,"timeFrame":83},"Pharmacokinetics: Area under the concentration-time curve from zero to infinity (AUC0-inf)",{"measure":95,"description":86,"timeFrame":83},"Pharmacokinetics: Terminal elimination half-life (t1\u002F2)",{"measure":97,"description":82,"timeFrame":83},"Pharmacokinetics: Volume of drug distribution during terminal phase (Vz)",{"measure":99,"description":86,"timeFrame":83},"Pharmacokinetics: Total body clearance of the drug (CL)",{"measure":101,"description":102,"timeFrame":83},"Pharmacokinetics: Area under the concentration-time curve from zero to last measurable concentration sample time (AUC0-last)","To characterize the PK profile of BHB810 in blood samples\n\nPhase 2 (Dose Optimization)",{"measure":104,"description":105,"timeFrame":83},"Incidence of antidrug antibodies (ADAs) in blood before and after BHB810 administration","To characterize the ADAs and PK profile of BHB810 in blood samples\n\nPhase 1 (Dose Escalation \\& Backfill Cohorts) Phase 2 (Dose Optimization)","ALL","18 Years",{"inclusion":109,"exclusion":117,"raw_text":131},[110,111,112,113,114,115,116],"Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.","Histologically confirmed advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on, was nonresponsive to, or for which no standard or available curative therapy exists.","Participants in Phase 1 Backfill Cohorts \\& Phase 2 must be CDH17-positive by central testing.","Other gastrointestinal (GI) tumor types may be enrolled in Backfill Cohorts and Phase 2.","At least 1 measurable target lesion at baseline per RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)","Provision of FFPE archival tumor tissue. Additional fresh biopsies at screening are required in Phase 1 Backfill Cohorts and Phase 2.","Adequate organ and marrow function as defined in the protocol",[118,119,120,121,122,123,124,125,126,127,128,129,130],"Prior cancer treatment as follows, relative to the first planned dose of trial intervention:","Chemotherapy or targeted therapy withing 4 weeks or 5-halflives (whichever is shorter)","Monoclonal antibody-based therapy (including ADCs) within 4 weeks","Immune checkpoint inhibitors within 4 weeks","Wide-field radiation therapy (\\>30% marrow-bearing bones) within 4 weeks or \\\u003C 2 weeks of focal palliative radiation to nontarget lesions","Prior treatment with a CDH17-directed therapy or an ADC with an auristatin (MMAE or MMAF)","Known hypersensitivity or allergic reaction to BHB810 or it's excipients","Left ventricular ejection fraction \\\u003C50% or history of congestive heart failure Class III\u002FIV","QTc interval \\> 470 msec, history of risk factors for Torsade de Pointes, or taking a medication known to prolong QT\u002FQTc","Pregnant or breastfeeding females, or if you or your partner are planning to become pregnant","Known or suspected brain metastases, leptomeningeal disease, or spinal cord compression. Participants with stable, treated brain metastases may be enrolled.","Current treatment with a strong CYP3A4 inhibitor or inducer, Pgp inhibitor, or CYP3A4 sensitive substrate within 2 weeks of first dose of trial intervention","Any condition that may compromise participant safety, compliance, or interfere with the evaluation of the study drug.","Inclusion Criteria:\n\n* Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.\n* Histologically confirmed advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on, was nonresponsive to, or for which no standard or available curative therapy exists.\n\n  * Participants in Phase 1 Backfill Cohorts \\& Phase 2 must be CDH17-positive by central testing.\n  * Other gastrointestinal (GI) tumor types may be enrolled in Backfill Cohorts and Phase 2.\n* At least 1 measurable target lesion at baseline per RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)\n* Provision of FFPE archival tumor tissue. Additional fresh biopsies at screening are required in Phase 1 Backfill Cohorts and Phase 2.\n* Adequate organ and marrow function as defined in the protocol\n\nExclusion Criteria:\n\n* Prior cancer treatment as follows, relative to the first planned dose of trial intervention:\n\n  * Chemotherapy or targeted therapy withing 4 weeks or 5-halflives (whichever is shorter)\n  * Monoclonal antibody-based therapy (including ADCs) within 4 weeks\n  * Immune checkpoint inhibitors within 4 weeks\n  * Wide-field radiation therapy (\\>30% marrow-bearing bones) within 4 weeks or \\\u003C 2 weeks of focal palliative radiation to nontarget lesions\n* Prior treatment with a CDH17-directed therapy or an ADC with an auristatin (MMAE or MMAF)\n* Known hypersensitivity or allergic reaction to BHB810 or it's excipients\n* Left ventricular ejection fraction \\\u003C50% or history of congestive heart failure Class III\u002FIV\n* QTc interval \\> 470 msec, history of risk factors for Torsade de Pointes, or taking a medication known to prolong QT\u002FQTc\n* Pregnant or breastfeeding females, or if you or your partner are planning to become pregnant\n* Known or suspected brain metastases, leptomeningeal disease, or spinal cord compression. Participants with stable, treated brain metastases may be enrolled.\n* Current treatment with a strong CYP3A4 inhibitor or inducer, Pgp inhibitor, or CYP3A4 sensitive substrate within 2 weeks of first dose of trial intervention\n* Any condition that may compromise participant safety, compliance, or interfere with the evaluation of the study drug.",[133,134],"ADULT","OLDER_ADULT",[136],{"facility":137,"status":8,"city":138,"state":139,"zip":140,"country":141,"contacts":142,"geoPoint":151},"NEXT Virginia","Fairfax","Virginia","22031","United States",[143,148],{"name":144,"role":145,"phone":146,"email":147},"Maybelle De La Rosa","CONTACT","703-783-4518","mdelarosa@nextoncology.com",{"name":149,"role":150},"Alexander Spira, MD","PRINCIPAL_INVESTIGATOR",{"lat":152,"lon":153},38.84622,-77.30637,[],[],[],[],{"nct_id":4,"conditions":159,"biomarkers":164},[160,19,161,162,163],"Colorectal Carcinoma","Gastroesophageal Junction Adenocarcinoma","Malignant Digestive System Neoplasm","Pancreatic Carcinoma",[165],"Cadherin-17",{"nct_id":4,"found":167,"summary":168,"prompt_version":178},true,{"design":169,"status":170,"heading":171,"summary":172,"follow_up":173,"word_count":174,"commitments":175,"compensation":176,"drugs_mentioned":177},"This is an interventional study, meaning participants will receive a specific treatment. It is designed to enroll 164 participants.","completed","BHB810 for Advanced Gastric and GEJ Adenocarcinoma","This study is testing a drug called BHB810 for adults with advanced gastric (stomach) cancer or gastroesophageal junction (GEJ) adenocarcinoma. These are cancers that have grown or spread, or for which standard treatments are no longer working or available. The main goals are to see how safe BHB810 is, how well your body tolerates it, and how effective it is in treating the cancer. Participants will receive BHB810 through an IV every two weeks. The study will also look at how the drug moves through your body and how your body reacts to it. The study aims to enroll 164 participants.","Safety will be monitored for 30 days after the last dose, which is an average of 6 months. Overall Response Rate will be measured from screening through the end of treatment, an average of 6 months.",101,"Participants will receive BHB810 through an IV infusion every two weeks while on study treatment. The study will monitor for side effects and how the drug affects your body.","Not stated in the trial record.",[47],"v2"]