[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Evergreen Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":104},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,67,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100618102","phase-1-pharmacokinetic-study-to-evaluate-safety-and-tolerability-of-eg-101-in-healthy-female-volunteers-as-a-safety-lead-in-for-dosing-in-pregnant-women-with-severe-pre-eclampsia-100618102",false,"NCT07327255","Pharmacokinetic Study to Evaluate Safety and Tolerability of EG-101 in Healthy Female Volunteers as a Safety Lead-In for Dosing in Pregnant Women With Severe Pre-eclampsia","A Phase I, Randomized, Cross-over, Single-Center, Single Dose Fasted Study of EG-101 IV Injection (EG-ZNMP-01) in Healthy Volunteers to Serve as a Safety Lead-In for Dosing in Pregnant Women With Severe Pre-eclampsia","Key Inclusion Criteria:\n\n1. Healthy adult female volunteers, 18 to 55 years of age, inclusive, at first Check-In Visit\n2. Body mass index (BMI) ≥18.5 to ≤32 kg\u002Fm2 at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg \u002F m2 where m2 is height in meters squared.)\n3. All female subjects must be nonpregnant, nonlactating and either postmenopausal, surgically sterile, or using contraceptive regimens more than 3 months. All females must have a negative serum pregnancy test at Screening and Check-in Visit. Effective methods of contraception include a dual method of contraception: condom with spermicide in conjunction with use of an intrauterine device (IUD), condom with spermicide in conjunction with use of a diaphragm, condom with birth control patch or vaginal ring, or condom with oral, injectable, or implanted contraceptive. Surgical sterility is documented through documented: hysterectomy, partial hysterectomy, bilateral oophorectomy, or bilateral tubal ligation at least 6 months prior to Screening. Postmenopausal sterility is documented by absence of menses for at least 12 months prior to Screening plus serum FSH ≥40 mIU\u002FmL and estradiol \\\u003C30 pg\u002FmL at screening\n4. Male subjects, are not enrolled into this study\n5. Medically healthy on the basis of medical history, and physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems), as determined by the Investigator at Screening and each Check-In Visit\n\nKey Exclusion Criteria:\n\n1. Females who are pregnant, lactating, or likely to become pregnant during the study\n2. History and\u002For recent evidence within 6 months prior to Screening of alcohol or drug\u002Fsubstance abuse disorder\n3. Subjects with a history of hypersensitivity to Zanamivir or any component of study medication\n4. History of clinically significant allergies including drug allergies or allergic bronchial asthma or related bronchospastic conditions\n5. Subjects who have history of unexplained syncope or fainting or a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia or dehydration",true,"FEMALE","18 Years","55 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Preeclampsia is one of the leading causes of maternal and fetal death. It is a syndrome of pregnant women and is usually characterized by new onset of hypertension and proteinuria after 20 weeks of gestation. This disease is a multisystem disorder affects most maternal organs, predominantly the vascular, renal, hepatic, cerebral and coagulation systems. While hypertension is almost always a symptom of this disease, preeclampsia is not the same as essential hypertension.\n\nThis is a single-center, randomized, open-label, 4 period, 3-way crossover, single dose fasted study to evaluate the safety, tolerability and pharmacokinetics of four ascending doses of the EG-101 IV injection in healthy volunteers.\n\nTwenty-four subjects in total, with eight subjects randomly assigned to one of three different sequences for variation of doses under fasted conditions. Dosing duration is approximately 4 weeks and followed by the follow-up for each subject.",[28],"Pre-eclampsia",[30],"Phase 1 Study","NOT_YET_RECRUITING","2026-01-08",{"date":34,"type":35},"2026-01-12","ACTUAL",{"date":37,"type":22},"2026-06",{"date":39,"type":22},"2027-03",{"name":41,"class":42},"Evergreen Therapeutics, Inc.","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100452326","phase-2-study-to-evaluate-safety-and-efficacy-of-eg-301-in-patients-with-nonfocal-geographic-atrophy-secondary-to-dry-amd-100452326","NCT05170048","Study to Evaluate Safety and Efficacy of EG-301 in Patients With Nonfocal Geographic Atrophy Secondary to Dry-AMD","A Phase 2, Parallel, Randomized, Open-label, Controlled Study of EG-301 150 mg Daily in Patients With Nonfocal Geographic Atrophy Secondary to Dry-AMD","Key Inclusion Criteria:\n\n1. Male or female patients, 50 to 75 years of age at screening visit\n2. Subject has signed the Informed Consent form\n3. Subjects with intermediate nonfocal geographic atrophy secondary to Non-Exudative (dry) AMD having ETDRS BCVA between 35 and 80 letters read (equivalent to 20\u002F25 - 20\u002F200 on Snellen Chart) with the level of vision caused by the non-exudative AMD and no other factor\u002Fs\n4. Subjects with symptomatic decrease in visual acuity in the last 12 months\n5. Subjects with confirmed diagnosis of geographic atrophy (GA) secondary to dAMD in the study eye\\* as evidenced by the following characteristics:\n\n   * Non-center involving GA lesions that reside completely within the FAF imaging field (field 2, 30 degree image centered on the fovea)\n   * Total GA area is ≥2.5 and ≤ 17.5 mm2 (1 and 7 disk areas \\[DA\\])\n   * If GA is multifocal, at least one focal lesion must be \\>1.25 mm2 (0.5 DA)\n   * Combination of areas of RPE disturbances described as a pattern of hyper or hypo-pigmentation in the junctional zone of GA. Absence of hyper-autofluorescence is exclusionary\n6. Subjects with evidence of reasonably well-preserved areas of RPE by clinical examination and well-defined RPE and outer segment ellipsoid line by OCT examination in the central 1 mm of the macula as confirmed by the central reading center. More specifically, reasonably well- preserved central 1 mm of the macula means:\n\n   * The RPE and outer retinal layers throughout the central 1 mm are intact\n   * No signs of NVAMD such as intraretinal or sub retinal fluid, or sub retinal hyper-reflective material\n   * No serous pigment epithelium detachments \\>100 microns in height\n   * Sufficiently clear ocular media, adequate pupillary dilation, fixation to permit quality fundus imaging, and able to cooperate sufficiently for adequate ophthalmic visual function testing and anatomic assessment\n\nKey Exclusion Criteria:\n\n1. Females who are pregnant, nursing, planning a pregnancy during the study or who are of childbearing potential not using a reliable method of contraception and\u002For not willing to maintain a reliable method of contraception during their participation in the study. Women of childbearing potential with a positive urine pregnancy test administered at baseline are not eligible to receive study drug\n2. Prior cataract surgery is allowed up to 90 days before the baseline visit, but refractive surgery in either eye may not be conducted during the study.\n3. Subject with exudative AMD or choroidal neovascularization (CNV), including any evidence of retinal pigment epithelium rips, detachments or evidence of neovascularization anywhere in either eye based on SD-OCT imaging and\u002For fluorescein angiography as assessed by the Reading Center\n4. Subjects who had anti-VEGF IVT in either eye in the past 90 days\n5. Subjects who have received any drug or herbal medicine known to inhibit CYP2D6 enzyme activity prior to the first dose of the investigational drug (the patient can be enrolled if the washout period is ≥5 half-lives of the CYP2D6 inhibitor), or subjects who need to continue receiving these medications during the study period. (Refer to Appendix 1 for a list of CYP2D6 inhibitors)\n6. Subjects with moderate or severe renal impairment as indicated by an estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin, calculated by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)","ALL","50 Years","75 Years",{"count":54,"type":22},90,[56],"PHASE2","This is a parallel, randomized, open-label, controlled study to evaluate the efficacy and safety of oral EG-301 in patients with intermediate non-exudative (dry) age-related macular degeneration (dAMD).\n\nNinety patients will be randomly allocated in a 2:1 ratio to one of two treatment arms for at least 6 months duration. The two treatment arms are:\n\n1. AREDS2 supplements (Control Group, N=30)\n2. AREDS2 supplements plus EG-DPMP-01 150 mg daily (Experimental Group, N=60)",[59],"Non-Exudative (Dry) Age-related Macular Degeneration (dAMD)","2025-12-02",{"date":62,"type":35},"2025-12-08",{"date":37,"type":22},{"date":65,"type":22},"2028-06",{"name":41,"class":42},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100445190","phase-3-efficacy-and-safety-of-a-repurposed-drug-added-to-the-combination-of-len-plus-pem-in-advanced-endometrial-cancer-100445190","NCT05077215","Efficacy and Safety of a Repurposed Drug Added to the Combination of Len Plus Pem in Advanced Endometrial Cancer","A Phase 3, Randomized, Open-Label, Active-Controlled, Superiority Trial of EG007, Added to the Combination of Lenvatinib Plus Pembrolizumab vs. Lenvatinib Plus Pembrolizumab in Patients With Advanced Endometrial Cancer","Inclusion Criteria:\n\n1. Female, 18 years and older at the time of informed consent, who has a histologically confirmed diagnosis of endometrial carcinoma, endometroid histology, that is not MSI-H or dMMR.\n2. Documented evidence of advanced (Stage III or IV), or recurrent EC.\n3. Must have a recurrence or progressed on a platinum containing chemotherapy regimen and are not candidates for curative surgery or radiation\n4. Has historical or fresh tumor biopsy specimen for confirmation of mismatch repair (MMR) status as not MSI-H or dMMR.\n5. Has measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1).\n6. Is a candidate for initiation of treatment with the combined regimen of Keytruda plus Lenvima (Len+Pem) at the doses specified as the Len+Pem Regimen (per Labeling August 2021).\n7. Life expectancy of 12 weeks or more.\n8. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days of starting study treatment.\n9. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150\u002F90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the first dose of study treatment.\n10. Adequate renal function defined as creatinine less than or equal to 1.5 × ULN (upper limit of normal) or calculated creatinine clearance greater than or equal to 40 mL\u002Fmin per the Cockcroft and Gault formula with creatinine levels greater than 1.5 × ULN.\n\nAdditional detail upon request.\n\nExclusion Criteria:\n\n1. Brain metastasis: Brain metastases must be asymptomatic, fully treated and stable and not requiring steroids within 4 weeks prior to study treatment initiation.\n2. Has carcinosarcoma (malignant mixed mullerian tumor), serous carcinoma, endometrial leiomyosarcoma and endometrial stromal sarcomas.\n3. Has failed treatment of lenvatinib + pembrolizumab in prior lines of therapy.\n4. Prior anticancer treatment within 28 days (or 5 times the half-life time, whichever is shorter) or any investigational agent within 30 days prior to the first dose of study drugs. All acute toxicities related to prior treatments must be resolved to Grade less than or equal to 1.\n5. Participants must have recovered adequately from any toxicity and\u002For complications from major surgery prior to starting therapy.\n6. Participants having greater than 1+ proteinuria on urinalysis will undergo 24-h urine collection for quantitative assessment of proteinuria. Participants with urine protein greater than or equal to 1 g\u002F24-hour will be ineligible.\n7. Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of the study drugs\n8. Has a pre-existing greater than or equal (\\>=) Grade 3 gastrointestinal or non-gastrointestinal fistula.\n9. Has radiographic evidence of major blood vessel invasion\u002Finfiltration.\n10. Has clinically significant tumor bleeding within 2 weeks prior to the first dose of study treatment.\n\nAdditional detail upon request.",{"count":75,"type":22},450,[77],"PHASE3","This is a Phase 3, multicenter, randomized, open-label trial to evaluate whether EG-007 plus Len+Pem is superior to Len+Pem alone in patients with advanced endometrial cancer (Stage III or IV). This trial will be preceded by a safety lead-in study with up to 28 patients (the safety lead-in is a separate, free-standing protocol).\n\nApproximately 450 patients will be randomized equally (1:1) to receive EG-007 plus Len+Pem or Len+Pem alone. The randomization will be stratified by the following stratification factors:\n\n* Diagnosis Classification (advanced Stage III\u002FIV vs. recurrent endometrial cancer)\n* ECOG score at baseline (0 vs 1)\n* Geographic region (Asia vs ROW)",[80],"Advanced Endometrial Cancer",{"date":62,"type":35},{"date":83,"type":22},"2026-12",{"date":85,"type":22},"2027-12",{"name":41,"class":42},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":103,"locationsCount":4},"100447414","phase-2-safety-lead-in-study-of-a-repurposed-drug-added-to-the-combination-of-len-plus-pem-100447414","NCT05106127","Safety Lead-In Study of a Repurposed Drug Added to the Combination of Len Plus Pem","A Phase 2, Open-Label, Safety Lead-In With Long Term Safety Study of EG-007, Added to the Combination of Lenvatinib Plus Pembrolizumab","Inclusion Criteria:\n\n1. Female, 18 years and older at the time of informed consent, who has a histologically confirmed diagnosis of endometrial carcinoma, endometroid histology, that is not MSI-H or dMMR ).\n2. Documented evidence of advanced (Stage III or IV), or recurrent EC.\n3. Must have a recurrence or progressed on a platinum containing chemotherapy regimen and are not candidates for curative surgery or radiation\n4. Has historical or fresh tumor biopsy specimen for confirmation of mismatch repair (MMR) status as not MSI-H or dMMR.\n5. Has measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1).\n6. Is a candidate for initiation of treatment with the combined regimen of Keytruda plus Lenvima (Len+Pem) OR IS CURRENTLY RECEIVING a tolerated regimen of Len+Pem at the doses specified as the Len+Pem Regimen (per Labeling July 2021)\n7. Life expectancy of 12 weeks or more.\n8. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days of starting study treatment.\n9. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150\u002F90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Cycle 1 Day 1.\n10. Adequate renal function defined as creatinine less than or equal to 1.5 × ULN (upper limit of normal) or calculated creatinine clearance greater than or equal to 40 mL\u002Fmin per the Cockcroft and Gault formula with creatinine levels greater than 1.5 × ULN.\n\nAdditional detail upon request.\n\nExclusion Criteria:\n\n1. Brain metastasis: Previously treated CNS disease needs to be asymptomatic and does not require steroids. Brain metastases must be asymptomatic, fully treated and stable and not requiring steroids within 4 weeks prior to study treatment initiation.\n2. Has carcinosarcoma (malignant mixed mullerian tumor), serous carcinoma, endometrial leiomyosarcoma and endometrial stromal sarcomas.\n3. Has failed treatment of lenvatinib + pembrolizumab in prior lines of therapy.\n4. Except for the allowance of ongoing use of Len+Pem, the protocol excludes patients having received any other prior anticancer treatment within 28 days (or 5 times the half-life time, whichever is shorter) or any investigational agent within 30 days prior to the first dose of study drugs. All acute toxicities related to prior treatments must be resolved to Grade less than or equal to 1.\n5. Participants must have recovered adequately from any toxicity and\u002For complications from major surgery prior to starting therapy.\n6. Participants having greater than 1+ proteinuria on urinalysis will undergo 24-h urine collection for quantitative assessment of proteinuria. Participants with urine protein greater than or equal to 1 g\u002F24-hour will be ineligible.\n7. Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of the study drugs\n8. Has a pre-existing greater than or equal (\\>=) Grade 3 gastrointestinal or non-gastrointestinal fistula.\n9. Has radiographic evidence of major blood vessel invasion\u002Finfiltration.\n10. Has clinically significant tumor bleeding within 2 weeks prior to the first dose of study treatment.\n\nAdditional detail upon request.",{"count":95,"type":22},28,[56],"This is a Phase 2 trial Safety Lead-in trial conducted in 3 cohorts of patients.\n\nA safety lead-in study of the impact of adding the Repurposed Drugs a third agent will be conducted prior to opening enrollment into the compassionate use study. All patients enrolled in the safety lead-in study may continue long-term treatment under this protocol without interruption of dosing.",[80],{"date":62,"type":35},{"date":101,"type":22},"2026-08",{"date":39,"type":22},{"name":41,"class":42},""]