[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612367":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":27,"locations":26,"responsibleParty":35,"collaborators":26,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":26,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":26,"enrollmentInfo":46,"targetDuration":26,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":63,"overallStatus":72,"whyStopped":26,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":26},{"fullName":5,"class":6},"AccSalus Biosciences, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants receive ACC-1898 tablets orally once daily (QD) in 21-day cycles","EXPERIMENTAL","Dose-Escalation (Part 1): Determine the maximum tolerated dose (MTD) and\u002For optimal biologic dose (OBD) using an Accelerated Titration → Bayesian Optimal Interval (ATD-BOIN) design.\n\nTreatment continues until disease progression, unacceptable toxicity, withdrawal, or study completion",[13],"Drug: ACC-1898",{"label":15,"type":10,"description":16,"interventionNames":17},"ACC-1898 Dose Expansion Cohorts","Participants will receive ACC-1898 tablets orally once daily (QD) in repeating 21-day cycles at dose levels determined from Part 1 (dose escalation).\n\nThis Phase 1b dose-expansion phase will enroll patients with selected advanced or metastatic solid tumors to further characterize the safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of ACC-1898 at the recommended Part 2 dose(s).\n\nUp to three tumor-specific expansion cohorts may be opened. Within each indication, participants may be randomized between two ACC-1898 dose levels that demonstrated acceptable safety and evidence of activity in Part 1.\n\nTreatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or study completion.\n\nPaired tumor biopsies and optional blood samples will be collected to explore biomarker and PK\u002FPD correlations.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","ACC-1898","ACC-1898 is an oral small-molecule tyrosine kinase inhibitor (TKI).\n\nAdministered once daily by mouth in continuous 21-day cycles.\n\nStarting doses range from 80 mg to 300 mg QD, with possible intra-patient dose modifications.\n\nArm(s)\u002FGroup(s):\n\n* Arm 1 - ACC-1898 Monotherapy\n* Arm 2 - ACC-1898 Monotherapy\n\nRoute of Administration:\n\nOral (tablet)\n\nDose Form:\n\nFilm-coated tablet (20 mg and 40 mg strengths)\n\nTreatment Duration:\n\nUp to 2 years or until disease progression or unacceptable toxicity.",[15,9],[25],"ST-1898",null,[28,33],{"name":29,"role":30,"phone":31,"phoneExt":26,"email":32},"Jaymes Holland","CONTACT","6502732627","jaymes.holland@accsalus.com",{"name":29,"role":30,"phone":31,"phoneExt":26,"email":34},"jaymes.s.holland@gmail.com",{"type":36,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100612367","phase-1-study-of-acc-1898-in-adult-participants-with-advanced-solid-tumors-100612367",false,"NCT07252661","Study of ACC-1898 in Adult Participants With Advanced Solid Tumors","An Open-Label, Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of ACC-1898 (Tyrosine Kinase Inhibitor) in Adult Participants With Advanced Solid Tumors.","Inclusion Criteria (highlights):\n\nAdults (≥ 18 years) with histologically confirmed advanced or metastatic solid tumors that have progressed after standard therapy or for which no effective standard option exists.\n\nAt least one measurable lesion per RECIST v1.1.\n\nECOG (Eastern Cooperative Oncology Group) Performance Status 0-1 (2 may be allowed with Medical Monitor approval).\n\nResolved acute effects from prior therapy to ≤ Grade 1 per CTCAE v5.0.\n\nAdequate organ function (hematologic, hepatic, renal).\n\nAble to swallow oral medication and comply with study requirements.\n\nSigned informed consent.\n\nWomen of childbearing potential must have a negative pregnancy test and use highly effective contraception during and for 180 days after treatment; men must use condoms and avoid sperm donation for 120 days post-treatment.\n\nExclusion Criteria (highlights):\n\nKnown primary CNS (central nervous system) malignancy or symptomatic brain metastases requiring supraphysiologic steroids (unless stable ≥ 3 months after therapy).\n\nActive or uncontrolled infection (including HBV, HCV, HIV) not meeting protocol control criteria.\n\nHBV: Hepatitis B Virus HCV: Hepatitis C Virus HIV: Human Immunodeficiency Virus\n\nSignificant GI disease that could impair oral drug absorption (e.g., unresolved Grade \\> 1 nausea\u002Fdiarrhea).\n\nActive liver or biliary disease (except stable metastases or Gilbert's syndrome).\n\nBaseline QTcF (QT Interval Corrected Using Fridericia Formula) \\> 450 msec (men) or \\> 470 msec (women), clinically significant ECG abnormalities, or heart rate \\\u003C 45 bpm unless approved by cardiology review.\n\nPregnant or breastfeeding women.\n\nAny other medical condition that, in the investigator's judgment, would interfere with study participation or pose unacceptable risk.","ALL","18 Years",{"count":47,"type":48},40,"ESTIMATED","INTERVENTIONAL",[51],"PHASE1","This is a research study of an experimental drug called ACC-1898. ACC-1898 is an oral tyrosine kinase inhibitor (TKI) that blocks several proteins kinases which may help cancer cells grow and spread.\n\nThe purpose of this Phase 1 clinical trial is to find a safe dose of ACC-1898 and to understand how the body absorbs, distributes, and eliminates the drug (pharmacokinetics \u002F PK). The study will also look for early signs that ACC-1898 may slow or shrink tumors and explore possible biological markers related to drug activity.\n\nAdults with advanced or metastatic solid tumors who have no remaining standard treatment options may take part.\n\nAll participants will receive ACC-1898 tablets by mouth once daily in repeating 21-day cycles. Treatment may continue for up to two years if the cancer does not worsen and side effects are manageable.\n\nSafety information, laboratory results and imaging scans (CT or MRI) will be collected regularly.\n\nThe study will first test different dose levels (dose-escalation phase) and may later expand enrollment in selected tumor types once a recommended dose is found.",[54,55,56,57,58,59,60,61,62],"Hepatocellular Carcinoma","Renal Cell Carcinoma","Thyroid Carcinoma, Medullary","Thyroid Carcinoma Primary Differentiated","Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","Melanoma","Gall Bladder Cancer","Advanced Solid Tumor",[64,65,66,67,68,69,70,71,21],"Advanced Solid Tumors","Metastatic Cancer","Tyrosine Kinase Inhibitor","VEGFR","MET","RET","AXL","Multi-target TKI","NOT_YET_RECRUITING","2025-11-25",{"date":75,"type":76},"2025-11-28","ACTUAL",{"date":78,"type":48},"2026-01",{"date":80,"type":48},"2027-12",{"name":5,"class":6}]