[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589613":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":33,"responsibleParty":113,"collaborators":20,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":20,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":20,"enrollmentInfo":124,"targetDuration":20,"studyType":127,"phases":128,"briefSummary":131,"conditions":132,"keywords":20,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Hummingbird Bioscience","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HMBD-501","EXPERIMENTAL","HMBD-501 intravenous injection once every 3 weeks; successive cohorts will receive escalating doses of HMBD-501 until the RP2D is reached",[13],"Biological: ENV-501",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","ENV-501","ENV-501 is a HER3-targeted antibody-drug conjugate (ADC) with a humanized monoclonal antibody (mAb) conjugated with a chemotherapeutic payload via a linker.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Kevin Heller","STUDY_DIRECTOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Kevin Heller, Dr","CONTACT","+65 6978 9377","HMBD Patients \u003Cpatients@hummingbirdbio.com>",{"name":32,"role":28,"phone":20,"phoneExt":20,"email":30},"Hummingbird Bioscience Team",[34,50,61,72,83,93,105],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Research Site","RECRUITING","La Jolla","California","92093","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-117.2742,32.84727,{"lat":46,"lon":45},[49],{"name":20,"role":28,"phone":20,"phoneExt":20,"email":30},{"facility":35,"status":36,"city":51,"state":52,"zip":53,"country":40,"countryCode":41,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Indianapolis","Indiana","46250",{"type":43,"coordinates":55},[56,57],-86.15804,39.76838,{"lat":57,"lon":56},[60],{"name":20,"role":28,"phone":20,"phoneExt":20,"email":30},{"facility":35,"status":36,"city":62,"state":63,"zip":64,"country":40,"countryCode":41,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Farmington Hills","Michigan","48334",{"type":43,"coordinates":66},[67,68],-83.37716,42.48531,{"lat":68,"lon":67},[71],{"name":20,"role":28,"phone":20,"phoneExt":20,"email":30},{"facility":35,"status":36,"city":73,"state":74,"zip":75,"country":40,"countryCode":41,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Dallas","Texas","75230",{"type":43,"coordinates":77},[78,79],-96.80667,32.78306,{"lat":79,"lon":78},[82],{"name":20,"role":28,"phone":20,"phoneExt":20,"email":30},{"facility":35,"status":36,"city":84,"state":74,"zip":85,"country":40,"countryCode":41,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"San Antonio","78229",{"type":43,"coordinates":87},[88,89],-98.49363,29.42412,{"lat":89,"lon":88},[92],{"name":20,"role":28,"phone":20,"phoneExt":20,"email":30},{"facility":35,"status":94,"city":95,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":104,"contacts":20},"WITHDRAWN","Campbelltown","New South Wales","2560","Australia","AU",{"type":43,"coordinates":101},[102,103],150.81667,-34.06667,{"lat":103,"lon":102},{"facility":35,"status":94,"city":106,"state":96,"zip":107,"country":98,"countryCode":99,"cosmosGeoPoint":108,"geoPoint":112,"contacts":20},"Miranda","2228",{"type":43,"coordinates":109},[110,111],151.10005,-34.03857,{"lat":111,"lon":110},{"type":114,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100589613","phase-1-a-phase-12-clinical-trial-to-assess-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-hmbd-501-in-patients-with-her3-expressing-solid-tumors-100589613",false,"NCT06956690","A Phase 1\u002F2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMBD-501 in Patients With HER3-Expressing Solid Tumors","A First-in-Human, Open-label, Phase 1\u002F2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMBD-501 in Patients With Advanced-Stage, Relapsed\u002FRefractory HER3-Expressing Solid Tumors","Inclusion Criteria:\n\n* Body weight ≥ 40 kg.\n* Willing and able to provide signed written informed consent before any study-related screening procedures are performed.\n* Patients with histologically or cytologically confirmed diagnosis of advanced-stage or metastatic HER3+ solid tumors that are relapsed or refractory to or ineligible for standard therapy, or for whom no standard therapy is available; or the patient has documented their refusal of standard of care therapies. These include the following:\n\n  1. Unresectable or metastatic cutaneous melanoma (HER3+)\n  2. Locally advanced or metastatic mutated EGFR (mEGFR) NSCLC (HER3+)\n  3. Unresectable, locally advanced or metastatic breast cancer\n  4. Relapsed or refractory solid tumors, with documented HER3+ expression such as Pancreatic Ductal Adenocarcinoma (PDAC) and gastric cancers, may be allowed in the protocol following sponsor approval on a case-by -case basis.\n* If molecular pathology report to confirm HER3+ status is not available, willingness to undergo fresh tumor biopsy for retrospective assessment of HER3+ status following enrollment..\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.\n* Contraceptive requirements:\n\n  1. Women of childbearing potential (WOCBP) must use contraception from at least 28 days prior to study start, during the study, and for at least 6 months after the last dose of study drug.\n  2. Males who are sexually active with partner(s) who are WOCBP must agree to use a male condom with spermicide beginning at study start, during the study and for at least 6 months after the last dose of study drug.\n* Females must:\n\n  1. Agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 6 months after the last dose of study drug.\n  2. Agree to not breastfeed and do not plan to become pregnant during the study and for at least 6 months after the last dose of study drug.\n* Males must:\n\n  1. Agree to not donate sperm beginning at study start, during the study, and for at least 6 months after the last dose of study drug.\n  2. Agree to not plan to father a child beginning at study start, during the study, and for at least 6 months after last dose of study drug.\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* Any of the following treatment interventions within the specified time frame prior to study drug administration at study start:\n\n  1. Any anti-tumor-directed drug therapy within 21 days or 5 times the elimination half-life (whichever is shorter).\n  2. Treatment with investigational drugs within 21 days.\n  3. Major surgery within 21 days.\n  4. Radiation therapy ≤4 weeks or radiotherapy that included \\>30% of the bone marrow.\n  5. Autologous or allogeneic stem cell transplantation or allogeneic tissue\u002Forgan transplant within 3 months.\n  6. CYP3A4 strong inhibitor (including any prescription or non-prescription drugs or herbal supplements) ≤4 half-lives.\n  7. CYP3A4 strong inducer ≤4 half-lives.\n  8. OATP1B inhibitor (including any prescription or non-prescription drugs or herbal supplements) ≤4 half-lives.\n* Prior treatment with a HER3-targeted ADC or any exatecan- or exatecan-derivative-conjugated ADC inhibitor as last line of therapy.\n* Prior treatment with a topoisomerase I inhibitor as last line of therapy.\n* Primary immune deficiency (e.g. congenital syndromes).\n* Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment within 2 weeks prior to study start.\n* Known\u002Fsuspected hypersensitivity against ENV-501, human or humanized immunoglobulin Gs (IgGs), or their ingredients.\n* History of noninfectious or drug-induced pneumonitis or interstitial lung disease (ILD).\n* Known seropositivity (except after vaccination or confirmed cure for hepatitis) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).\n* Leptomeningeal disease, symptomatic or uncontrolled (active) brain metastasis (note: brain metastases not requiring steroids or anti-epileptic therapy are allowed if stable for ≥4 weeks prior to study start and patient is neurologically stable).\n* Pregnant or WOCBP who have a positive b-human chorionic gonadotropin (HCG) test result at Screening or within 7 days prior to study start.\n* Patients with second malignancies that are active (uncontrolled, metastatic) or requiring therapy.\n* Patient who is an immediate family member (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study site or the Sponsor.","ALL","18 Years",{"count":125,"type":126},180,"ESTIMATED","INTERVENTIONAL",[129,130],"PHASE1","PHASE2","This study is a Phase 1\u002F2, first-in-human, open-label, clinical trial to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of HMBD-501 in patients with advanced-stage, relapsed and\u002For refractory human epidermal growth factor receptor 3 (HER3)-expressing solid tumors. The study consists of 2 phases: a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2).\n\nThe primary objectives of Phase 1 are to characterize the overall safety and tolerability profile of increasing doses of HMBD-501 in patients with advanced-stage solid tumors and identify the recommended Phase 2 dose (RP2D) of ENV-501. During Phase 1, successive cohorts of patients will receive escalating doses of HMBD-501. The results of the dose escalation will determine the RP2D and dosing schedule of HMBD-501 to be administered in the Phase 2 part of the study. The primary objective of Phase 2 is to evaluate the preliminary clinical efficacy of HMBD-501 in dose expansion cohorts.",[133,134,135],"Melanoma (Skin)","Non Small Cell Lung Cancer","Breast Cancer","2026-02-26",{"date":138,"type":139},"2026-03-02","ACTUAL",{"date":141,"type":139},"2025-12-17",{"date":143,"type":126},"2027-07",{"name":5,"class":6},7]