[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Regor Pharmaceuticals Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100633256","phase-1-study-of-rgt-490-in-patients-with-pik3ca-mutated-advanced-solid-tumors-100633256",false,"NCT07524322","Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors","A Phase 1\u002F1b Open-Label, Multicenter, First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of RGT-490 as a Single Agent in Adult Subjects With Locally Advanced or Metastatic PIK3CA-Mutated Solid Tumors Including HR+\u002FHER2- Breast Cancers","Inclusion Criteria:\n\n* Adults with metastatic or locally advanced, unresectable solid tumors that have progressed on or after at least one available therapy.\n* Presence of one or more documented activating PIK3CA mutation in tumor tissue and\u002For blood.\n* At least 1 measurable lesion or evaluable disease per RECIST v1.1.\n* An ECOG performance status of 0 or 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Diabetes mellitus requiring anti-hyperglycemic medication.\n* Prior treatment with PI3Kα inhibitors\n* Symptomatic, untreated, or uncontrolled central nervous system metastases.\n* Receipt of any local or systemic anticancer therapy or investigational anticancer agent within a protocol-defined washout period prior to study treatment.\n* Unresolved clinically significant toxicities from prior anticancer therapy\n* History of a another malignancy within 2 years prior to screening (exception adequately treated cancers).","ALL","18 Years",{"count":19,"type":20},63,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a phase 1\u002F1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational oral therapy, in adults with locally advanced or metastatic solid tumors including breast cancer.\n\nParticipants enrolled in the study have advanced disease that is not amendable to curative treatment and whose tumors harbor alterations in the PI3KCA gene.",[26,27,28,29,30,31,32,33,34],"Breast Cancer","Ovarian Cancer","Endometrial Cancer","PIK3CA Mutation","HER2- Negative Breast Cancer","Advanced Breast Cancer","Unresectable Solid Tumor","Hormone Receptor Positive Tumor","Cervical Cancer","RECRUITING","2026-06-30",{"date":38,"type":39},"2026-07-02","ACTUAL",{"date":41,"type":20},"2026-06",{"date":43,"type":20},"2028-10",{"name":45,"class":46},"Regor Pharmaceuticals Inc.","INDUSTRY",5,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100462691","phase-1-fih-study-of-rgt-419b-alone-and-with-endocrine-therapy-in-hr-positive-her2-negative-advancedmetastatic-breast-cancer-100462691","NCT05304962","FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced\u002FMetastatic Breast Cancer","First-in-Human, Escalating Oral Dose Study of RGT-419B Given Alone and With Endocrine Therapy in Subjects With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced\u002FMetastatic Breast Cancer","Inclusion Criteria:\n\n1. Male or female \\>\u002F= 18 years old\n2. ECOG Performance Status 0 to 1\n3. Subjects must have histologically or cytologically confirmed diagnosis of ER+, HER2- ABC consistent with ASCO CAP guidelines that is locally advanced and unresectable (Stage III) or metastatic (Stage IV) BC.\n4. Measurable AND evaluable lesions at baseline per RECIST v1.1.\n5. Eligible subjects must meet all of the following criteria:\n\n   * Progression after receiving 1 line of prior cyclin-dependent kinase 4 and 6 inhibitor (CDK4\u002F6i) therapy combined with HT in the MBC setting (up to 1 additional line of CDK4\u002F6i is permitted in the post-surgical adjuvant setting);\n\n     * Subjects must have received therapy for ≥3 months in the MBC setting, or for ≥6 months in the adjuvant setting, prior to progression\n   * Progression after ≤3 lines of prior HT therapy (regardless of whether it is HT alone or in combination with other therapies)\n\n     * Prior HT combination agents, including SERD, SERM or AI, must have received formal approval by regulatory agency.\n   * ≤ 1 prior line of chemotherapy in the metastatic setting\n6. Adequate organ function\n7. Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n1. Presence of visceral metastases with severe organ dysfunction as evidence by signs and symptoms, laboratory studies, lymphangitic spread and\u002For rapid progression of disease\n2. Pregnant or planning to become pregnant\n3. Prior irradiation to \\>25% of the bone marrow and\u002For inadequate bone marrow function or evidence of clinically significant end-organ damage\n4. Major surgery, chemotherapy, targeted therapy, experimental agents, or radiation within 14-28 days prior to Cycle 1, Day 1\n5. Active, serious medical condition that is not well controlled with locally approved medications allowed by the protocol\n6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in the study",{"count":56,"type":20},64,[23],"This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of RGT-419B administered orally as monotherapy OR in combination with Hormonal Therapy in subjects with HR+, HER2- locally advanced and unresectable (Stage III) or metastatic (Stage IV) breast cancer whose disease has progressed during prior therapy with an approved CDK4\u002F6i plus hormonal therapy.",[26],[26],"2026-03-27",{"date":63,"type":39},"2026-04-02",{"date":65,"type":39},"2022-03-04",{"date":67,"type":20},"2026-12-30",{"name":45,"class":46},8,""]