[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hr-her2--advanced-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hr-her2--advanced-breast-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100592820","phase-1-orion-1-study-of-avzo-023-as-a-single-agent-and-in-combination-with-avzo-021-andor-endocrine-therapy-in-advanced-solid-tumors-100592820",false,"NCT06998407","ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and\u002For Endocrine Therapy in Advanced Solid Tumors","A Phase 1\u002F2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-023 as a Single Agent, and in Combination With AVZO-021 and\u002For Endocrine Therapy in Patients With Advanced Solid Tumors","AVZO-023-1001","Key Inclusion Criteria:\n\n* Male or female aged ≥ 18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1 and life expectancy \\> 3 months\n* Patients with histologically or cytologically proven advanced malignancies of preferred indications\n* Measurable disease (as assessed by investigator using RECIST v1.1) is preferred in Phase 1 dose escalation, unless otherwise specified in the protocol, and in all patients in Phase 2. Bone only disease is allowed in dose escalation.\n* Agree to provide molecular test report results to confirm eligibility and archival tumor samples and\u002For fresh biopsy, as applicable\n* Adequate renal, liver, and bone marrow function\n\nKey Exclusion Criteria:\n\n* Patients should not have received any prior selective investigational CDK (CDK2, CDK4, CDK2\u002F4, CDK2\u002F4\u002F6) inhibitors\n* Has known active brain metastasis (have either previously untreated intracranial CNS metastasis or previously treated intracranial central nervous system (CNS) metastasis with radiologically documented new or progressing CNS lesions) or leptomeningeal disease\n* Other concurrent invasive malignancy or a prior invasive malignancy for which treatment was completed within 3 years before the first dose on study except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or colorectal adenomatous polyps\n* Last anticancer treatment within 2 weeks (4 weeks for biologic, immunotherapy or ADC) or 5 half-lives of the drug, whichever is shorter, prior to first dose on study\n* Major surgery within 4 weeks prior to first dose on study\n* Have received radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of study treatment, except for patients receiving whole brain radiotherapy, which must be completed at least 4 weeks prior to the first dose of study treatment. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have active radiation pneumonitis\n* Strong or moderate CYP3A4 inhibitors or inducers within 2 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose on study\n* History of serious cardiovascular conditions within 6 months prior to first dose on study\n* Unresolved toxicities from prior therapy greater than Grade 1 (per CTCAE version 5.0) (with exceptions of alopecia, vitiligo, and ≤ Grade 2 peripheral neuropathy) prior to the first dose on study\n* History of drug-induced pneumonitis\u002Finterstitial lung disease\n* Confirmed loss of function mutation or deletion of Rb1 gene","ALL","18 Years",{"count":20,"type":21},380,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study, the first clinical trial of AVZO-023, aims to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-023 in patients with advanced solid tumors. AVZO-023 is an oral medication that inhibits cyclin-dependent kinase 4 (CDK4).",[28,29],"HR+\u002FHER2- Breast Cancer","HR+, HER2-, Advanced Breast Cancer","RECRUITING","2026-04-28",{"date":33,"type":34},"2026-05-04","ACTUAL",{"date":36,"type":34},"2025-08-20",{"date":38,"type":21},"2030-08",{"name":40,"class":41},"Avenzo Therapeutics, Inc.","INDUSTRY",14,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":62,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100505889","phase-1-study-of-avzo-021-in-patients-with-advanced-solid-tumors-100505889","NCT05867251","Study of AVZO-021 in Patients With Advanced Solid Tumors","A Phase 1\u002F2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-021 as a Single Agent and in Combination Therapy in Patients With Advanced Solid Tumors","Key Inclusion Criteria:\n\n1. Male or female aged ≥18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1.\n2. Disease-related inclusion criteria by study phase and part:\n\n   i) Phase 1a Monotherapy Dose Escalation: Patients with locally advanced or metastatic HR+\u002FHER2- breast cancer, CCNE1-amplified tumors that are either epithelial ovarian cancer, primary peritoneal cancer, fallopian tube cancer, endometrial cancer or TNBC, with no other oncogenic driver mutations that are treatable and standard therapies are no longer effective, appropriate, or safe in the opinion of the investigator and medical monitor. Patients with any additional tumor type with CCNE1 amplification can be enrolled only if clinical data is supportive and approved by medical monitor (Cohort 1A).\n\n   ii) Phase 1b Combination Dose Escalation: histologically or cytologically confirmed diagnosis of locally advanced or metastatic HR+ HER2- (HER2-low may be allowed if failed standard of care therapy) breast cancer, who have been previously treated with inhibitor of CDK4\u002F6 and endocrine therapy(Cohorts 1B1, 1B2, 1B3, 1B4, and 1B5); or histologically or cytologically confirmed diagnosis of CCNE1- amplified, locally advanced or metastatic, platinum-refractory or platinum-resistant EOC, primary peritoneal, or fallopian tube cancer (Cohort 1C).\n\n   iii) Phase 2a Monotherapy dose expansion: Histologically or cytologically confirmed diagnosis of locally advanced or metastatic CCNE1 amplified epithelial ovarian cancer, primary peritoneal cancer, fallopian tube cancer, endometrial cancer or TNBC, with no other oncogenic driver mutations that are treatable and standard therapies are no longer effective, appropriate, or safe in the opinion of the investigator and medical monitor (Cohort 2A).\n\n   iv) Phase 2b Combination dose expansion: Histologically or cytologically confirmed diagnosis of locally advanced or metastatic HR+\u002FHER2- (HER2-low may be allowed if failed standard of care therapy) breast cancer who have been previously treated with no more than 1 prior CDK4\u002F6 inhibitor and endocrine therapy (Cohorts 2B1, 2B2, 2B3, 2B4, and 2B5); or Histologically or cytologically confirmed diagnosis of locally advanced or metastatic, CCNE1-amplified, platinum-refractory or platinum-resistant EOC, primary peritoneal cancer, or fallopian tube cancer (Cohort 2C).\n3. No more than 2 prior cytotoxic chemotherapy regimens for locally advanced\u002Fmetastatic disease (excepting patients treated with an antibody-drug conjugate, with ovarian cancer if there disease is platinum resistant or refractory, having progressed beyond all SOC care; and patients who have received prior chemotherapy in the adjuvant or neoadjuvant setting \\>12 months prior to starting AVZO-021 treatment).\n4. Measurable disease as determined by RECIST version 1.1.\n5. Adequate bone marrow and organ function.\n6. Ability to swallow capsules or tablets.\n\nKey Exclusion Criteria:\n\n1. Received an investigational agent or anticancer therapy within 2 weeks, or 5 half-lives of the drug, whichever is shorter, prior to planned start of AVZO-021.\n2. Received any CDK2 inhibitor, protein kinase membrane associated tyrosine\u002Fthreonine 1 (PKMYT1) inhibitor, or WEE1 inhibitor anticancer therapy. For cohort B5, prior therapy with topoisomerase inhibitors is not permitted.\n3. Undergone major surgery within 4 weeks prior to planned start of AVZO-021.\n4. Received radiotherapy for palliation within 7 days of the first dose of study treatment, unless specified otherwise in the protocol.\n5. Active CNS metastases or confirmed leptomeningeal disease are not eligible.\n6. Unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade \\>1 at the time of starting study treatment.\n7. Clinically unstable cardiac function as described in the protocol.\n8. Any active or chronic infection\u002Fdisease that compromises the immune system.\n9. Current treatment with strong or moderate cytochrome P450 (CYP)3A4 inhibitors or inducers.\n10. Active second malignancy unless in remission with life expectancy \\> 2 years and with documented sponsor approval.\n11. Pregnancy, lactation, or plans to breastfeed during the study or within 6 months of the last dose of study intervention.",{"count":51,"type":21},430,[24,25],"This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors. AVZO-021 is an oral medication that inhibits cyclin-dependent kinase 2 (CDK 2).",[55,28,29,56,57,58,59,60,61],"Advanced Solid Tumor","CCNE1 Amplification","Epithelial Ovarian Cancer","Primary Peritoneal Cancer","Fallopian Tube Cancer","Endometrial Cancer","TNBC - Triple-Negative Breast Cancer",[63,28,64,65,56,57,58,59,60,66],"Advanced solid tumor","Breast Cancer","Advanced Breast Cancer","Triple Negative Breast Cancer","2025-11-17",{"date":69,"type":34},"2025-11-19",{"date":71,"type":34},"2023-08-30",{"date":73,"type":21},"2030-01-31",{"name":40,"class":41},13,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100579693","phase-1-a-study-of-invikafusp-alfa-star0602-a-selective-t-cell-receptor-tcr-targeting-bifunctional-antibody-fusion-molecule-in-combination-with-sacituzumab-govitecan-in-participants-with-advanced-solid-tumors-100579693","NCT06827613","A Study of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Advanced Solid Tumors","A Phase 1b\u002F2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Unresectable, Locally Advanced, or Metastatic Solid Tumors (START-002)","START-002","Inclusion Criteria:\n\n1. Have measurable disease as per RECIST v1.1 criteria and documented by CT and\u002For MRI. Cutaneous or subcutaneous lesions must be measurable by calipers.\n2. Tumor Type:\n\n   * mTNBC (Safety Run-in and Cohort A): Progression or recurrence of locally advanced or metastatic TNBC\n   * HR+\u002FHER2- mBC (Safety Run-in and Cohort B): Progression or recurrence of locally advanced or metastatic HR+\u002FHER2- breast cancer\n3. Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:\n\nNo concurrent treatment for CNS disease (eg, surgery, radiation, corticosteroids \\> 10 mg prednisone\u002Fday or equivalent); No concurrent leptomeningeal disease or cord compression.\n\nExclusion Criteria:\n\n1. History of known autoimmune disease with exceptions of:\n\n   * Vitiligo\n   * Psoriasis\n   * Atopic dermatitis or other autoimmune skin condition not requiring systemic treatment\n   * History of Graves' disease, now euthyroid for \\> 4 weeks\n   * Hypothyroidism managed by thyroid replacement\n   * Alopecia\n   * Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs\n   * Adrenal insufficiency well-controlled on replacement therapy\n2. Major surgery or traumatic injury within 8 weeks before first dose of study intervention\n3. Unhealed wounds from surgery or injury\n4. Clinically significant cardiovascular\u002Fvascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises\n5. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study intervention.\n6. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study intervention administration. Inactivated annual influenza vaccination is allowed.\n7. Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.\n8. Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas.\n9. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation)\n10. Treatment with \\>10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study intervention. Exceptions may be made for participants who have had allergic reactions to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed",{"count":85,"type":21},50,[24,25],"This is a Phase 1b\u002F2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab Govitecan in Participants with Unresectable, Locally Advanced, or Metastatic Solid Tumors.",[89,29],"Triple Negative Locally Advanced Non-resectable Breast Cancer","2025-09-19",{"date":92,"type":34},"2025-09-24",{"date":94,"type":34},"2025-03-24",{"date":96,"type":21},"2028-01",{"name":98,"class":41},"Marengo Therapeutics, Inc.",8]