[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"open-label\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:open-label":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100643791","phase-1-a-phase-1b-open-label-study-of-rec-617-a-selective-cdk7-inhibitor-in-patients-with-metastatic-or-unresectable-rb1-negative-leiomyosarcoma-after-prior-systemic-therapy-100643791",false,"NCT07633756","A Phase 1b, Open-Label Study Of REC-617, A Selective CDK7 Inhibitor, In Patients With Metastatic Or Unresectable RB1-Negative Leiomyosarcoma After Prior Systemic Therapy","Eligibility Criteria A. Disease Characteristics\n\n* Histologically confirmed leiomyosarcoma (any site of origin).\n* RB1-negative tumor, as assessed by immunohistochemistry (IHC) with a cutoff of 0% versus any expression Participants will have measurable diseases by RECIST 1.1. Previously ablated\u002F radiated\u002Ftreated areas can only be counted towards measurable disease if there is unequivocal progression after directed therapy.\n* Participant will have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases, as confirmed by a radiologist, if appropriate, and as deemed safe by the Investigator. If there is only one target lesion per RECIST 1.1 which is accessible to biopsy, this lesion should be at least 2cm.\n\nB. Prior and Current Therapy Requirements\n\n* At least one prior line of systemic therapy. C. Participants Characteristics\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of REC-617 in Participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status ≤ 2 (Karnofsky ≥60%,).\n* Life expectancy of \\>3 months, as determined by the investigator.\n* Ability to swallow and retain oral medication.\n* Ability to understand and the willingness to sign a written informed consent document and comply with study procedures.\n\nD. Organ and Marrow Function Requirements\n\nParticipants will have adequate organ and marrow functions as defined below:\n\nHemoglobin ≥8.5 g\u002FdL. Absolute neutrophil count ≥1,000\u002FmcL Platelets ≥150,000\u002FmcL, no platelet transfusion within 7 days prior to screening visit Total bilirubin ≤ institutional upper limit of normal (ULN) (except Participants with Gilbert's syndrome, who must have total bilirubin \\\u003C 3.0 mg\u002FdL) AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN INR ≤1.5 except for Participants on oral anticoagulants Creatinine clearance ≥60 mL\u002Fmin based on the Cockcroft-Gault equation or method standard to institution E. Viral and Infectious Disease Requirements\n\n* Participants may not have active or chronic infections with hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) F. CNS and Cardiac Requirements\n* Participants with asymptomatic treated CNS lesions who have completed treatment ≥30 days prior with documented stability on imaging and are on a stable steroid dose are eligible.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, Participants should be class 2B or better.\n* Participants should not have a QTcF \\>470 msec or history of torsades de pointes or history of congenital long QT syndrome.\n\nG. Reproductive\u002FContraception Requirements\n\nThe effects of REC-617 on the developing human fetus are unknown. For this reason and because CDK7 inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men will agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female Participants, between the onset of menses (as early as 8 years of age) and 55 years unless the Participant presents with an applicable exclusionary factor which may be one of the following:\n\n* Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n* History of hysterectomy or bilateral salpingo-oophorectomy.\n* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n* History of bilateral tubal ligation or another surgical sterilization procedure.\n\n  * Participants are eligible to participate if they agree to use 2 methods of contraception, approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\nMen and women treated or enrolled on this protocol will also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of REC-617 administration.\n\nExclusion Criteria A. Concurrent Treatments and Investigational Agents\n\n* Participants who are receiving any other investigational agents or have received any other investigational agent within 3 weeks prior to enrollment.\n* Current enrollment in another clinical study unless it is non-interventional or the follow-up period of an interventional study.\n* Prior treatment with radiotherapy (including radio-labeled spheres and\u002For cyberknife, hepatic arterial embolization (with or without chemotherapy) or cryotherapy\u002Fablation) is allowed if these therapies did not affect the areas of measurable disease being used for this protocol.\n* Received medications known to prolong QTc within 5 half-lives before the first dose of the study treatment. List of medications that prolong QTc can be obtained from crediblemeds.org.\n* Administration of a live vaccine within 28 days of starting study treatment and for up to 1 month after the final dose of study treatment or anticipation that such vaccine will be required during the study. Note: mRNA-based vaccines for COVID-19 are allowed as well as inactivated flu vaccines.\n* Has had or is scheduled to have major surgery \\\u003C28 days prior to the first dose of study treatment.\n\nB. Disease or Cancer-Related Exclusions\n\n* Active concurrent second malignancy within 2 years of trial enrollment. Note: Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Examples include non-melanomatous skin cancer, in situ carcinoma, or low-risk prostate cancer.\n* Unresolved or unstable toxic side-effects of prior anticancer therapy, except fatigue, alopecia, infertility, peripheral neuropathy, or those relating to palliative radiotherapy within 6 weeks prior to first dose of study treatment will have resolved to Grade 1 or less.\n\nC. Other comorbidities affecting participation\n\n* Active gastrointestinal bleeding.\n* Evidence of severe or uncontrolled systemic disease or psychiatric illness that, in the investigator's judgment, would limit safety or compliance.\n* Impaired gastrointestinal absorption\n* History of allergic reactions to compounds like REC-617. D. Transplant History\n* Prior organ or allogeneic stem-cell transplantation","ALL","18 Years",{"count":18,"type":19},15,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","To learn if the study drug REC-617 can help to control LMS. The safety of REC-617 will also be studied.",[25,26,27,28,29],"Phase 1b","Open Label","REC-617","RB1-Negative","Leiomyosarcoma","NOT_YET_RECRUITING","2026-06-19",{"date":33,"type":34},"2026-06-24","ACTUAL",{"date":36,"type":19},"2026-10-19",{"date":38,"type":19},"2031-12-26",{"name":40,"class":41},"M.D. Anderson Cancer Center","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":16,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":20,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100644443","phase-1-a-randomized-multicenter-open-label-active-controlled-phase-ib-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-multiple-intravaginal-doses-of-gensci142-in-patients-with-bacterial-vaginosis-bv-100644443","NCT07663838","A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)","Inclusion Criteria:\n\n1. Women of childbearing age aged 18-50 years (inclusive of the cut-off values, as of the date of signing the informed consent form), with a history of sexual activity and a regular menstrual cycle (21-35 days, inclusive of the cut-off values);\n2. Screening visits were conducted for women clinically diagnosed with bacterial vaginosis who had not received any treatment for bacterial vaginosis since the onset of their current symptoms. The clinical diagnostic criteria for bacterial vaginosis are as follows:\n\n   1. At least one clinical symptom (itching, odour, abnormal vaginal discharge),\n   2. and at least three positive findings on the Amsel clinical assessment (with clue cells constituting more than 20% of the total vaginal epithelial cells being a mandatory criterion),\n   3. and a Nugent score of ≥7;\n3. Trial participants must agree to abstain from sexual intercourse for 48 hours prior to the first administration of the investigational medicinal product, throughout the treatment period, and for 48 hours prior to each return visit;\n4. be willing to use vaginal administration and agree to avoid the use of any vaginal products not specified in the trial protocol (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) throughout the trial period;\n5. Trial participants must voluntarily sign a written informed consent form prior to the trial;\n6. Trial participants must be able to understand the procedures and methods of this trial and be willing to strictly adhere to the clinical trial protocol to complete the trial.\n\nExclusion Criteria:\n\nMedical History\n\n1. Those currently suffering from any acute infection of the urinary or reproductive system, including but not limited to pelvic inflammatory disease, cervicitis, endometritis, and adnexitis;\n2. Those currently suffering from vulvovaginitis caused by other pathogens, including but not limited to Aerobic vaginitis, vulvovaginal candidiasis, trichomoniasis, gonorrhoea, genital herpes, and genital warts;\n3. Current presence of other vaginal or vulvar conditions, or being in the recovery phase following reproductive system surgery, where the investigator considers this to affect the trial evaluation;\n4. Patients currently receiving, or who will require during the trial, medications that reduce or antagonise oestrogen levels, such as gonadotropin-releasing hormoneagonists, high-potency progestogens and combined oral contraceptives;\n5. Patients with a history of or currently suffering from major diseases such as cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine or psychiatric disorders, where the investigator considers inclusion inappropriate;\n6. Women who are pregnant, breastfeeding, or have tested positive for pregnancy; or those planning to become pregnant during the trial; or those unable to use reliable contraception during the study;\n7. Individuals with impaired immunity or immune dysfunction, including but not limited to those currently undergoing treatment for malignant tumours, those with autoimmune diseases, or those currently using immunosuppressants;\n8. Participants with abnormal uterine bleeding, including prolonged menstrual periods (\\>7 days);\n9. Those who are menstruating at the time of the screening visit or who are expected to commence menstruation within 14 days;\n10. Participants who have received treatment with inhalational anaesthetics, antispasmodic anti-diarrhoeal agents, kaolin-containing anti-diarrhoeal agents, muscle relaxants, chloramphenicol or erythromycin, or opioid analgesics within 7 days prior to screening;\n11. Participants who had received treatment with topical or systemic broad-spectrum antibiotics (excluding nitroimidazole antibiotics that do not affect Lactobacillus) within 1 month prior to screening;\n12. Those who have undergone vaginal douching or other vaginal procedures involving antiseptic treatment within 1 month prior to screening;\n13. A history of severe allergy to the investigational medicinal product, any of its excipients, or vaginal effervescent preparations; or a predisposition to allergies (e.g. allergy to two or more medicines or foods); Diet and lifestyle\n14. Those with an average daily cigarette consumption of ≥5 cigarettes in the 30 days prior to screening;\n15. Those who have consumed more than 5 litres of beer, 600 ml of spirits with an alcohol content of 40%, or 2 litres of wine per week within the 6 months prior to screening; History of substance abuse or dependence\n16. History of substance abuse within the past year (e.g. cannabis, benzodiazepines, ketamine, morphine, cocaine, methamphetamine); Screening examinations\n17. Participants with clinically significant abnormalities or vaginal mucosal lesions (e.g. mucosal oedema, congestion, ulcers, erosions) identified during the screening colposcopy, as judged by the investigator, which may affect drug administration;\n18. During the screening period, based on an assessment of medical history, vital signs, physical examination, clinical laboratory tests and ancillary investigations, the investigator considers the subject's general health status unsuitable for inclusion;\n19. Participants with positive results in infectious disease screening \\[Hepatitis B surface antigen, Hepatitis C antibody, Human Immunodeficiency Virus antibody, or positive syphilis serology\\]; Other\n20. Participants who have participated in other clinical trials of medicinal products or medical devices within the 3 months prior to screening and have used the investigational medicinal product or device; or who participated in a clinical study 3 months prior but are still within the follow-up period of that study or within 5 half-lives of the investigational medicinal product (whichever is longer) at the time of screening;\n21. The investigator considers that the trial participant has any other condition rendering them unsuitable for participation in the trial, or any other medical condition that may impair the participant's ability to tolerate the investigational medicinal product or to continue with the procedures specified in this study.","FEMALE","50 Years",{"count":52,"type":19},30,[22],"A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial vaginosis (BV).",[56,57,58,59,60,61],"Randomized","Open-label","Safety","Tolerability","Pharmacokinetics","Bacterial Vaginosis","2026-06-17",{"date":64,"type":34},"2026-06-23",{"date":66,"type":19},"2026-06-15",{"date":68,"type":19},"2027-05-05",{"name":70,"class":71},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY",7,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":20,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100510653","phase-1-a-study-of-fx-909-in-patients-with-advanced-solid-malignancies-including-advanced-urothelial-carcinoma-100510653","NCT05929235","A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma","A Phase 1, First-in-Human, Dose-Escalation and Expansion Study of FX-909 (as Monotherapy or in Combination With Pembrolizumab) in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma","Part A\u002FB Inclusion Criteria:\n\n1. Able to understand and willing to sign an informed consent.\n2. Age ≥ 18 years.\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.\n4. An archival, paraffin-embedded, formalin-fixed, tumor sample (see Laboratory Manual for details) that in Part A is no more than 30 months old at the time of screening or in Part B is no more than 30 months old at time of pre-screening. If an archival tumor sample is not available or is older than 30 months, then the patient must consent to provide a fresh biopsy during screening.\n5. Part A: Histologically or cytologically diagnosed, locally advanced (unresectable) or metastatic solid malignancies that have progressed after all available standard therapy for the specific tumor type, or for which no standard therapy exists. Patients for whom standard therapies are intolerable or considered inappropriate by the Investigator are eligible.\n\n   Part B: Patients with histologically or cytologically confirmed, locally advanced (unresectable) or metastatic urothelial carcinoma exhibiting high levels of PPARG protein expression will be prospectively enrolled in this study. Eligibility will require a Tumor Positivity Score (TPS) of ≥ 60%, as determined by an investigational immunohistochemistry (IHC) assay for PPARG.\n\n   • Treated with ≤ 4 prior therapies for advanced or metastatic disease Patients in Part B must have progressed after all available standard therapy, been unable to tolerate standard therapy, or be considered inappropriate for standard therapy by the Investigator.\n6. Part A: Patients with or without measurable disease (as defined by RECIST version 1.1) will be eligible for enrollment.\n\nPart B: Patients must have measurable disease per RECIST version 1.1 with ≥ 1 site of measurable disease that has not been previously irradiated or has progressed after radiation therapy.\n\n7\\. Screening laboratory values meet the criteria outlined in Table 8.\n\no Hematologic criteria may be met with transfusion of blood products or administration of G-CSF, provided they are not given within 7 days prior to enrollment. Hematologic parameters must meet the inclusion criteria prior to dosing on Cycle 1 Day 1.\n\nPart A\u002FB Exclusion Criteria:\n\n1. Female patients who are pregnant (confirmed with a positive pregnancy test) or breastfeeding.\n2. Prior anticancer chemotherapy or small molecule targeted therapy, either investigational or commercially approved and available, within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of study drug administration. When the most recent therapy was a biological therapy (including antibody-drug conjugates), an immune-checkpoint inhibitor (eg, anti-PD(L)1 or anti-CTLA4), or immune agonist, patients should wait 4 weeks before starting therapy with FX-909. (See Exclusion Criterion 6 for required radiotherapy windows.)\n3. Prior therapy directly inhibiting PPARG or RXRA.\n4. Adverse events from prior therapy that have not returned to baseline or stabilized at Grade 1 (except alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, and Grade ≤ 2 neuropathy) prior to study drug administration.\n5. Prior major surgery (excluding placement of vascular access) within 4 weeks before study drug administration.\n6. Prior radiation therapy with an inadequate washout between the last dose and the start of study drug, defined as follows: 1) at least 2 weeks for palliative radiation to the extremities for osseous bone metastases is required; and 2) at least 4 weeks for radiation to non-extremity sites is required.\n7. History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease free. Exceptions include appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, melanoma in situ status-post full-thickness resection without recurrence, Stage 1 uterine cancer, localized prostate cancer that has been treated surgically with curative intent and presumed cured, or other malignancies with an expected curative outcome. Patients requiring adjuvant therapy within the past 2 years for another malignancy will not be considered to have been cured.\n8. QT interval corrected using Fridericia's Formula (QTcF) \\>470 msec in screening, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives.\n9. Known active diagnosis of lipodystrophy\u002Flipoatrophy, or an ongoing need to receive medications known to cause lipodystrophy\u002Flipoatrophy.\n10. Any active uncontrolled systemic bacterial, viral, or fungal infection requiring treatment.\n11. Known history of HIV seropositivity. Those who have no detectable viral load on highly active antiretroviral therapy (HAART) are permitted.\n12. Patients with chronic hepatitis B virus (HBV) infection. Patients are permitted with either universal prophylaxis or a pre-emptive treatment approach consistent with regional or national guidelines for patients who receive anticancer therapies.\n13. Active hepatitis C virus (HCV) infection. Those who have completed curative therapy for HCV and have no detectable viral load are permitted.\n14. Prior diagnosis of chronic or recurrent (\\> 1 episode) pancreatitis at any time or a diagnosis of acute pancreatitis within the 6 months prior to screening.\n15. Significant impairment of lung function indicated by resting oxygen saturations below 92% on room air or requiring chronic use of ambulatory supplemental oxygen.\n16. Uncontrolled or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or carcinomatous meningitis. Asymptomatic brain metastasis is allowed if they have been stable after appropriate radiotherapy for 1 month.\n17. Need for treatment with high doses of oral or intravenous steroids (\\> 10 mg\u002Fday prednisone or equivalent). Physiologic doses of corticosteroids for treatment of endocrinopathies may be continued if the patient is on a stable dose for at least 1 month.\n18. Need or anticipated need for treatment with a prohibited therapy during the treatment phase of this study.\n19. Concurrent participation in any other investigational therapeutic study.\n20. History of any of the following cardiovascular diseases:\n\n    o Recent history (within the 6 months prior to screening) of serious uncontrolled cardiac arrhythmia (including atrial fibrillation without adequate rate control) or clinically significant ECG abnormalities including second-degree (Type II) or third-degree atrioventricular node block\n\n    o Documented cerebrovascular event (stroke or transient ischemic attack), cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting, or bypass grafting within the 6 months prior to enrollment\n    * Congestive heart failure (Class III or IV) as defined by the New York Heart Association functional classification system\n    * Recent history (within the past 6 months) of symptomatic pericarditis\n21. Thromboembolic events and\u002For bleeding disorders ≤ 28 days (eg, deep vein thrombosis or pulmonary embolism) prior to the first dose of study drug.\n22. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which, in the Investigator's opinion, makes it undesirable for the patient to participate in the study or would jeopardize compliance with the protocol.\n23. Patients with type 1 diabetes mellitus, or type 2 diabetes mellitus that is not adequately controlled with diet, exercise, or oral hypoglycemic agents and\u002For injectable agents other than insulin (as defined by HbA1c and fasting plasma glucose criteria in Table 8. Patients taking insulin are excluded from the study. Medication for type 2 diabetes mellitus should have remained stable for the past 14 days prior to screening).\n24. Known hypersensitivity to FX-909 or any of its excipients.\n25. Patients with gastrointestinal disorders that may interfere with the ability to swallow tablets or absorb study medication.\n26. Patient is or has an immediate family member (eg, spouse, parent\u002Flegal guardian, sibling, or child) who is a member of the study site or Sponsor staff directly involved with this study, unless prospective Institutional Review Board (IRB) or Ethics Committee (EC) approval (by chair or designee) is given allowing exception to this criterion for a specific patient.\n27. Patients with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before study entry.\n28. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the patient's safety or study results.\n\nPart 1A1 Inclusion Criteria:\n\n1\\. Able to understand and willing to sign an informed consent 2. Aged 18 years or older on the day written informed consent is given 3. ECOG performance status 0 or 1 4. Histologically or cytologically confirmed, locally advanced (unresectable) or metastatic urothelial carcinoma by pathology report.\n\n5\\. Participants must have received and progressed after all available standard therapies known to confer clinical benefit, been unable to tolerate standard therapy, or be considered inappropriate for standard therapy by the Investigator.\n\n6\\. Must have progressed on treatment with an anti-PD-1\u002FL1 mAb administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria:\n\n1. Received at least 2 doses of an approved anti-PD-1\u002FL1 mAb.\n2. Documented disease progression after anti-PD-1\u002FL1 treatment (consistent with the principles of RECIST v1.1). The initial evidence of disease progression is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented disease progression, in the absence of rapid clinical progression (as defined in 2.c).\n3. Progressive disease has been documented within 12 weeks from the last dose of anti-PD-1\u002FL1 mAb.\n\n   1. Progressive disease is determined consistent with the principles of RECIST v1.1.\n   2. This determination is made by the investigator. Once disease progression is confirmed, the initial date of disease progression documentation will be considered the date of disease progression.\n\n   7\\. Measurable disease per RECIST 1.1 as assessed by the local site investigator\u002Fradiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.\n\n   8\\. Archival tumor tissue sample within 30 months of enrollment or newly obtained \\[core, incisional, OR excisional\\] biopsy of a tumor lesion not previously irradiated has been provided.\n\n   9\\. Participants who have AEs due to previous anticancer therapies (with the exception of alopecia or peripheral sensory neuropathy) must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible, as are participants with ≤Grade 2 neuropathy, hearing loss, or alopecia.\n\n   10\\. If male, agrees to use an adequate method of contraception starting with the first dose of study drug through 90 days after the last dose of study drug. Please see Section 10.3 for a list of acceptable birth control methods. Male participants must not donate sperm throughout the study period and for 90 days after the last dose of the study treatment.\n\n   11\\. Female participants of childbearing potential must have a negative serum pregnancy test at screening within 7 days of the Cycle 1 Day 1 dosing. Female participants of childbearing potential must agree to use a highly effective form of contraception, as defined in the protocol (Section 10.3), during the study and for 120 days after the last dose of study drug. To be considered NOT of childbearing potential, female participants must have had a hysterectomy or bilateral oophorectomy or be 1-year post-menopause or have had amenorrhea for a period of 12 months or longer in the absence of chemotherapy, anti-estrogens, or ovarian suppression.\n\n   12\\. HIV-infected participants must have well controlled HIV on ART, defined as:\n\n\u003C!-- -->\n\n1. Participants on ART must have a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening\n2. Participants on ART must have achieved and maintained virologic suppression, defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening\n3. It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months\n4. Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study.\n5. Participants with HIV should continue ongoing management by their health care provider(s), including monitoring of HIV viral load, CD4+ T-cell count, and appropriate supportive care measures.\n\n   13\\. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.\n\na. Hepatitis B screening tests are not required unless:\n\n1. Known history of HBV infection\n2. As mandated by local guidelines\n\n14\\. Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\nNote: Participants must have completed curative antiviral therapy at least 4 weeks prior to randomization.\n\n1. Hepatitis C screening tests are not required unless:\n\n   3\\. Known history of HCV infection 4. As mandated by local guidelines 15. Adequate organ function as defined in Table 20.\n\nPart 1A1 Exclusion Criteria:\n\n1. HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n2. Participants with type 1 diabetes mellitus, or type 2 diabetes mellitus that is not adequately controlled with diet, exercise, or oral hypoglycemic agents and\u002For injectable agents other than insulin (as defined by HbA1c and fasting plasma glucose criteria in Table 20. Participants taking insulin are excluded from the study. Medication for type 2 diabetes mellitus should have remained stable for the past 14 days prior to screening).\n3. Participants with gastrointestinal disorders that may interfere with the ability to swallow tablets or absorb study medication.\n4. Thromboembolic events and\u002For bleeding disorders ≤28 days (eg, deep vein thrombosis or pulmonary embolism) prior to the first dose of study drug.\n\n   Prior\u002FConcomitant Therapy\n5. Prior therapy inhibiting PPARG or RXRA.\n6. Received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis.\n7. Received prior systemic anticancer therapy within 2 weeks or 5 half-lives (whichever is shorter) before the start of study drug administration. When the most recent therapy was a biological therapy (including antibody-drug conjugates), an immune-checkpoint inhibitor (eg, anti-PD(L)1 or anti-CTLA4), or immune agonist, participants should wait 4 weeks before starting therapy with FX-909.\n8. Note: If participant underwent major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n9. Received prior radiotherapy within 2 weeks of the start of study intervention, or has radiation-related toxicities, requiring corticosteroids.\n10. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.\n11. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n\n    Prior\u002FConcurrent Clinical Study Experience\n12. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n\n    Diagnostic Assessments\n13. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.\n14. Prior diagnosis of chronic or recurrent (\\> 1 episode) pancreatitis at any time or a diagnosis of acute pancreatitis within the 6 months prior to screening,\n15. Significant impairment of lung function indicated by resting oxygen saturations below 92% or requiring chronic use of ambulatory supplemental oxygen.\n16. Known additional malignancy that is progressing or has required active treatment within the past 2 years.\n17. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.\n18. Known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention.\n19. Active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy (eg, thyroxine or physiologic corticosteroid).\n20. History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n21. Any active bacterial, viral, or fungal infection requiring systemic therapy.\n22. History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n23. Severe hypersensitivity (≥Grade 3) to FX-909 and pembrolizumab and\u002For any of its excipients.\n\n    Other Exclusions\n24. History of stem cell\u002Fsolid organ transplant.\n25. Participants who have not adequately recovered from major surgery or have ongoing surgical complications.\n26. Need or anticipated need for treatment with a prohibited therapy described in Section 21.11.2 during the treatment phase of this study\n27. If female, is pregnant, breastfeeding, or expecting to conceive, or if male, expect to father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug.\n28. Participant is or has an immediate family member who is a member of the study site or Sponsor staff directly involved with this study, unless prospective IRB or EC approval is given allowing exception to this criterion.\n29. Participants with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n30. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the participant's safety or study results.",{"count":81,"type":19},120,[22],"The goal of this clinical trial is to study the safety and tolerability in all advanced solid tumors, including advanced urothelial carcinoma.\n\nThe main question\\[s\\] it aims to answer are:\n\n* Is FX-909 safe and tolerable, as a monotherapy and in combination with Pembrolizumab\n* What is the right dose level for patients\n\nParticipants will be asked to take FX-909 daily in tablet form, or FX-909 daily and Pembrolizumab every 3 weeks, and record any outcomes from taking the drug. Participants will also be asked to return for multiple site visits for various blood tests and to collect blood and tumor samples as well as have regular CT\u002FMRI scans.",[85,86,26],"Advanced Urothelial Carcinoma","Oral Drug Administration","RECRUITING","2026-04-16",{"date":90,"type":34},"2026-04-20",{"date":92,"type":34},"2023-08-24",{"date":94,"type":19},"2028-01-30",{"name":96,"class":71},"Flare Therapeutics Inc.",12]