[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"progesterone-receptor-positive-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:progesterone-receptor-positive-breast-cancer":98},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,74],{"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":54,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100561192","phase-1-a-study-with-nkt3964-for-adults-with-advancedmetastatic-solid-tumors-100561192",false,"NCT06586957","A Study With NKT3964 for Adults With Advanced\u002FMetastatic Solid Tumors","A Phase 1, First-in-human, Open-label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral CDK2 Degrader NKT3964 in Adults With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n\\- Must have a pathologically confirmed advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. Part 1 only: subjects must be refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.\n\nDose Escalation:\n\n1. Ovarian cancer\n2. Endometrial cancer (only endometrioid subtype will require CCNE1 amplification)\n3. Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification\n4. Small cell lung cancer (SCLC)\n5. Triple-negative breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative)\n6. HR+ (includes estrogen-receptor or progesterone-receptor) and HER2- breast cancer (must have progressed following treatment with a CDK4\u002F6 inhibitor, and is not suitable for endocrine therapy \\[ET\\])\n7. Other solid tumors with CCNE1 amplification\n\nDose Expansion:\n\nPart 2A: HR+ and HER2- breast cancer that is locally advanced and unresectable (Stage III) or metastatic (Stage IV); previously treated with ≥1 line of standard of care (SOC) including CDK4\u002F6 inhibitor plus ET and not suitable for further ET. Subjects must have progressed after receiving therapy for ≥3 months in the metastatic setting or for ≥6 months in the adjuvant setting. Subjects must have received ≤2 lines of systemic cytotoxic therapy (chemotherapy or cytotoxic antibody drug conjugate \\[ADC\\]) in the metastatic setting..\n\nPart 2B: Advanced platinum-based-chemotherapy resistant or refractory epithelial ovarian\u002Ffallopian\u002Fprimary peritoneal carcinoma or clear cell ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least one platinum containing therapy and previously treated with ≤4 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease and with CCNE1 amplification.\n\nPart 2C: Advanced unresectable or metastatic gastric, GEJ or esophageal adenocarcinoma with progression on at least one systemic therapy and previously treated with ≤3 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease, with CCNE1 amplification as determined by NGS by local liquid or tissue test.\n\nPart 2D: Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease with CCNE1 amplification.\n\nPart 2E: Advanced\u002Frecurrent uterine carcinosarcoma previously treated with 1 prior platinum-based chemotherapy regimen and ≤3 prior lines of systemic therapy. Prior bevacizumab or PARP inhibitors are allowed and must be at least 3 weeks prior to the start of study drug.\n\n* Have adequate organ function\n* Subjects with female reproductive organs must be surgically sterile, post-menopausal, or must be willing to use highly effective method(s) of contraception\n* Ability to swallow oral medications.\n* Consent to provide archived tumor tissues and paired tumor biopsy at pretreatment\n\nExclusion Criteria:\n\n* Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and\u002For radiotherapy, or chemotherapy.\n* History of another malignancy with exceptions\n* History of lymphohistiocytic or lymphoid hyperplasia; hemophagocytic lymphohistiocytosis.\n* Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)\n* Clinically significant cardiovascular event within 6 months prior to start of NKT3964 treatment\n* Known active CNS metastases and\u002For carcinomatous meningitis\n* Active interstitial lung disease currently requiring treatment\n* History of uveitis, retinopathy or other clinically significant retinal disease\n* Active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease\n* Active wound healing from major surgery within 1 month or minor surgery within 10 days before the first dose of NKT3964.\n* Known human immunodeficiency virus (HIV), active hepatitis B or C infection\n* Prior investigative treatment with a selective or nonselective CDK2 inhibitor or degrader\n* Childs-Pugh class B or C cirrhosis or any other clinically significant liver disorder\n* Palliative radiation therapy within 14 days or other radiation therapy within 4 weeks prior to C1D1","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53],"Solid Tumor","Advanced Solid Tumor","Solid Tumor, Adult","Metastatic Tumor","Ovarian Cancer","Ovarian Neoplasms","Ovarian Carcinoma","Metastatic Ovarian Carcinoma","Endometrial Neoplasms","Endometrial Diseases","Metastatic Endometrial Cancer","Triple Negative Breast Cancer","Metastatic Endometrial Carcinoma","Advanced Endometrial Carcinoma","Advanced Ovarian Carcinoma","Gastric Cancer","Advanced Gastric Carcinoma","Metastatic Gastric Cancer","Metastatic Gastric Carcinoma","Small Cell Lung Cancer","Small Cell Lung Carcinoma","Triple Negative Breast Neoplasms","Platinum-resistant Ovarian Cancer","Platinum-refractory Ovarian Carcinoma","CCNE1 Amplification","Hormone Receptor Negative Breast Carcinoma","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","Progesterone-receptor-positive Breast Cancer",[55,56,57,58,59,60],"CDK 2 Inhibitor","CDK 4 Inhibitor","CDK 6 Inhibitor","CDK2 Degrader","Protein Degrader","PROTAC","RECRUITING","2026-04-16",{"date":64,"type":65},"2026-04-21","ACTUAL",{"date":67,"type":65},"2024-09-19",{"date":69,"type":20},"2029-05",{"name":71,"class":72},"NiKang Therapeutics, Inc.","INDUSTRY",19,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":104,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":149},"100505964","phase-1-pre-i-spy-phase-iib-oncology-platform-program-100505964","NCT05868226","PRE-I-SPY Phase I\u002FIb Oncology Platform Program","PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I\u002FIb Platform Trial","PRE-I-SPY-PI","General Inclusion Criteria (GIC):\n\n* GIC1: The participant must have ability to understand and willingness to provide signed written informed consent prior to any study related assessments and procedures and for collection of archival FFPE blocks (freshly cut 14 unstained tumor slides would be acceptable).\n* GIC2: Age ≥ 18 years at the time of signing the informed consent\n* GIC3: Gender: Male or female (premenopausal and postmenopausal)\n* GIC4: ECOG performance status Grade 0-2\n* GIC5: Estimated life expectancy \\> 12 weeks at the start of investigational medicinal product (IMP) treatment.\n* GIC6: Adequate organ function, evidenced by the following laboratory results within 30 days of the start of IMP:\n\n  * Absolute neutrophil count ≥ 1,500\u002Fmm3\n  * Platelet count ≥ 100,000\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002FdL with no blood transfusion in the past 28 days\n  * Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN\n  * Estimated Creatinine clearance (using Cockcroft-Gault formula) ≥ 60 mL\u002Fmin for small molecules and \\>30 mL\u002Fmin for monoclonal antibodies unless otherwise specified in the Arm Specific Eligibility.\n\nThese cut-off values may be modified with supporting data for specific drug regimens.\n\n* GIC7: Non-Pregnant: Serum or urine pregnancy test must be negative within 14 days of IMP treatment start in women of childbearing potential. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before enrollment, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. If male, they must agree to refrain from donating sperm during treatment.\n* GIC8: Contraception: Women of childbearing potential and men must be willing to use adequate contraception for the duration of protocol treatment. Additional information regarding contraception for the specific treatment arm will be added to the drug arm description. Adequate contraception is defined as one highly effective form (i.e., abstinence, (fe)male sterilization) OR two effective forms (e.g., non-hormonal IUD and condom \u002F occlusive cap with spermicidal foam \u002F gel \u002F film \u002F cream \u002F suppository).\n* GIC9: Prior therapy effects: Resolution of all acute toxic effects of prior therapy, including radiotherapy, to grade ≤1 and neuropathy to grade ≤2 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures.\n* GIC10: Participant compliance: Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Additional arm specific inclusion criteria as needed by drug arm regimen\n\nGeneral Exclusion Criteria (GEC):\n\n* GEC1: Wash out periods: No other anticancer therapy within the following periods:\n\n  * chemotherapy or investigational agents, 3 weeks\n  * mitomycin C and nitrosoureas, 6 weeks\n  * radiotherapy, 3 weeks\n  * targeted therapy, 2 weeks\n  * MAbs, ADCs, and immunotherapy, 3 weeks\n  * endocrine therapy, no washout needed\n* GEC2: Concurrent therapy with other Investigational Products.\n* GEC3: Prior history of drug\u002Fregimen hypersensitivity: History of infusion-related reactions and\u002For hypersensitivity to IMP or excipients of the study drug\u002Fdrugs which led to permanent discontinuation of the treatment.\n* GEC4: Uncontrolled intercurrent illness including (active infection, diabetes, pulmonary embolism in the past 6 months, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements).\n* GEC5: Cardiovascular disease: History (within 6 months prior to start IMP) of clinically significant cardiovascular disease such as unstable angina, congestive heart failure (CHF), myocardial infarction, uncontrolled hypertension, cardiac arrhythmia requiring medication, or baseline corrected QT by Fridericia's formula (QTcF) length \\> 470 msec for men and women. The QTcF cut-off value may be modified with supporting data for specific drug regimens.\n* GEC6: CNS tumoral spread: Active uncontrolled\u002Fsymptomatic central nervous system cancer\u002Fspinal cord compression. Previously treated and clinically stable lesions, as per Investigator's judgment, are permitted. Newly discovered asymptomatic lesions that are not life threatening and do not require urgent local treatment to ensure patient safety, after consultation with study regimen chaperones, may be permitted.\n* GEC7: Liver disease: Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis.\n* GEC8: Recent major surgery within 4 weeks prior to start IMP treatment\n* GEC9: Pregnancy or breastfeeding\n* GEC10: Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.\n* GEC11: Other conditions, which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study.\n* GEC12: Concomitant malignancies: A diagnosis of a malignancy in the 2 years prior to starting study treatment other than the disease under study. Exceptions include indolent or definitively treated malignancy not expected to require treatment during the study, affect the safety of subjects, or affect the endpoints of the trial.\n* Additional arm specific exclusion criteria as needed by drug arm regimen",{"count":83,"type":20},124,[23],"I-SPY Phase I\u002FIb (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and\u002For other oncology-based trials in a timely manner.",[87,88,89,90,91,92,93,94,37,95,96,97,98,51,26,28,99,100,101,102,103],"HER2-positive Breast Cancer","Metastatic Cancer","Metastatic Breast Cancer","Metastatic","HER2-positive Metastatic Breast Cancer","HER2 Mutation-Related Tumors","HER-2 Protein Overexpression","HER2-negative Breast Cancer","HR Positive","Hormone Receptor-positive Breast Cancer","Estrogen Receptor Positive Tumor","Progesterone Receptor-positive Breast Cancer","Solid Carcinoma","HER2 Low Breast Cancer","HER2 Low Breast Carcinoma","ER Positive Breast Cancer","PR-positive Breast Cancer",[105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138],"I-SPY Trials","Quantum Leap Healthcare Collaborative","QLHC","I-SPY","I-SPY2","I-SPY1","PRE-ISPY","PRE-I-SPY","I-SPY Phase 1","I-SPY Phase 1b","I-SPY-P1","ISPY","ISPYP1","I-SPY Phase 1 Platform","ISPY2","ISPY1","Phase 1 Platform","Phase 1 Oncology Platform","T-DXd naive","PRE1","PRE2","PRE3","PRE","PRE-I-SPY Phase 1","PRE-I-SPY Phase 1b","ALX148","T-DXd","Enhertu","Zanidatamab","Tucatinib","Ziihera","Tukysa","Evorpacept","QL","2025-04-01",{"date":141,"type":65},"2025-04-04",{"date":143,"type":65},"2023-02-15",{"date":145,"type":20},"2029-12-30",{"name":147,"class":148},"QuantumLeap Healthcare Collaborative","OTHER",7]