[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tubulis GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":124},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,75,98],{"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":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100539412","phase-1-fih-study-to-investigate-safety-pk-and-efficacy-of-the-napi2b-adc-tub-040-in-patients-with-proc-or-rr-adenocarcinoma-nsclc-100539412",false,"NCT06303505","FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r\u002Fr Adenocarcinoma NSCLC","A First-in-human Dose Escalation and Optimization Phase I\u002FIIa Study to Investigate Safety, Tolerability, PK, and Efficacy of the NaPi2b ADC TUB-040 in Patients With Platinum-resistant High-grade Ovarian Cancer (PROC) or r\u002Fr Adenocarcinoma Non-small Cell Lung Cancer (NSCLC)","NAPISTAR1-01","Inclusion Criteria (for all patients)\n\n1. Male or non-pregnant, non-breastfeeding female, age 18 years or older at the date of consent.\n2. Disease not amenable to curative intent treatment.\n3. Patients have exhausted the standard of care treatment (SoC) with expected survival benefit and are not denied SoC with expected survival benefit by participating in the trial.\n4. Radiologically measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, that includes at least 1 lesion not previously irradiated.\n5. Eastern Cooperative Oncology Group (ECOG) 0-1.\n6. Have a life expectancy of more than 12 weeks for disease-related mortality, as evaluated by the INV.\n7. Patients must be willing to sign an archival tissue release form for research purposes and determination of biomarker (eg NaPi2b) expression.\n8. Patients must be willing to undergo a non-contrast high resolution computed tomography (HRCT) of the thorax scan and pulmonary function testing (PFT) at screening.\n9. Adequate organ function\n10. Resolution of all acute toxic effects of prior therapy or surgical procedures to ≤grade 1 (except alopecia, hyperpigmentation, or discoloration (incl. vitiligo) of the skin and nails, stable immune-related toxicity such as hypothyroidism on hormone replacement, adrenal insufficiency on ≤10 mg daily prednisone \\[or equivalent\\], chronic grade 2 peripheral sensory neuropathy after prior taxane therapy).\n11. Patients of childbearing potential (FCBP) who are sexually active with a non-sterilized partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of patients assigned female at birth. Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the patient for the duration of the study treatment and the above-referred period after the end of the exposure. Periodic abstinence (e.g., calendar ovulation, symptothermal, post-ovulation methods), the rhythm method, and the withdrawal method are not acceptable methods of contraception.\n12. In the opinion of the investigator, the patient must be able to understand, give written informed consent, and comply with all study-related procedures, medication use, and evaluations.\n13. The patient must not have a history of non-compliance with medical regimens or be considered potentially unreliable and\u002For uncooperative.\n14. The patient must be willing to sign and date the informed consent form (ICF)\n\nExclusion Criteria (for all patients)\n\n1. The patient is pregnant, lactating or breastfeeding or has a positive serum pregnancy test during the screening period.\n2. History of hypersensitivity to exatecan or excipients of the TUB-040 formulation, including ADCs with deruxtecan, exatecan or camptothecan as a payload.\n3. Disease that is refractory to topoisomerase-I inhibitors, defined as progression during or within 6 months of the last infusion.\n4. Patients are not allowed to participate in interventional clinical studies either concurrently or within the previous 28 days or within 5 half-lives of any investigational pharmacologic agents or imaging materials, including dyes, investigational surgical techniques, or devices.\n5. Patients with spinal cord compression or active central nervous system disease.\n6. Prior radiotherapy \\\u003C2 weeks from trial inclusion.\n7. Major surgery within 21 days prior to signing the ICF, unless the patient is recovered at that time.\n8. Has a history of non-infectious ILD\u002Fpneumonitis\u002Fradiation pneumonitis that required steroids or has current ILD\u002Fpneumonitis.\n9. Has an oxygen saturation of \\\u003C93% on room air at rest.\n10. Has a forced vital capacity of \\\u003C60% and diffusing capacity of the lung for carbon monoxide \\\u003C70%.\n11. Has a QTcF \\>470 ms\n12. History of nephrotic syndrome\n13. Active corneal disease, or history of corneal disease within 12 months prior to enrollment.\n14. Active, uncontrolled impairment of the urogenital, renal, hepatobiliary, cardiovascular, gastrointestinal, neurologic, or hematopoietic systems which, in the opinion of the investigator, would predispose the patient to the development of complications from the administration of protocol therapy.\n15. History of another malignancy with ongoing treatment or not yet free from disease for 2 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome.\n16. Documented other concurrent non-malignant comorbidities such as unstable or uncontrolled pectoral angina, myocardial infarction during the last 6 months, valvular heart disease that requires treatment, acute myocarditis, or congestive heart failure (CHF) (New York Heart Association III or IV).\n17. Any concurrent chemotherapy, radiotherapy (except for local radiation therapy of lesions that may cause imminent complications), immunotherapy, or corticoid therapy.\n18. Live vaccines within 30 days prior to study entry.\n19. Patients with acute or chronic infections such as:\n\n    1. Patients who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks and have an undetectable HBV viral load prior to randomization.\n    2. Patients with a history of HCV infection are eligible if HCV viral load is undetectable at screening.\n    3. HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection\u002Fdisease\n    4. Any other known unresolved and active bacterial, viral, fungal, mycobacterial, or other infection at screening.\n    5. History of severe and recurrent infections per INV judgment.\n    6. History of progressive multifocal leukoencephalopathy","ALL","18 Years",{"count":20,"type":21},250,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The purpose of this multicentric, open label trial (NAPISTAR 1-01) is to evaluate the safety\u002Ftolerability, pharmacokinetics and preliminary efficacy of TUB-040 and to find the best dose of TUB-040 in patients with ovarian cancer and Non Small Cell Lung Cancer. TUB-040 is an antibody-drug-conjugate which delivers a topoisomerase I inhibitor to tumor cells which overexpress the target NaPi2b. The study consists of two parts: In dose escalation, ovarian cancer patients and lung cancer patients receive increasing doses of TUB-040 until the maximal tolerated dose is found. In dose optimization, at least two doses are compared with each other to determine which dose is optimal for patients.\n\nTUB-040 is given IV every 3 weeks until the disease progresses or the patient has to stop due to side effects.",[28,29],"Ovarian Cancer","Non-small Cell Lung Cancer",[31,32,33],"TUB-040","ADC","PROC","RECRUITING","2026-08-13",{"date":37,"type":38},"2026-08-17","ACTUAL",{"date":40,"type":38},"2024-06-12",{"date":42,"type":21},"2027-12",{"name":44,"class":45},"Tubulis GmbH","INDUSTRY",16,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100566595","phase-1-first-in-human-study-of-tub-030-in-patients-with-advanced-solid-tumors-100566595","NCT06657222","First in Human Study of TUB-030 in Patients With Advanced Solid Tumors","A Multicenter FIH Dose Escalation and Optimization Phase I\u002FIIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)","Inclusion Criteria:\n\n1. Male or non-pregnant, non-breastfeeding female aged 18 years or older\n2. Adequate organ function\n3. Patients who received anti-cancer treatment including chemotherapy, biological therapy, endocrine therapy, PARP inhibitor, or other oral or investigational drugs must have had their last dose at least 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives, whichever is shorter, before C1D1\n4. AEs related to prior therapy, radiotherapy or surgical procedures must resolve to ≤grade 1.\n5. For patients with known brain metastases, evidence of clinically stable disease post radiation therapy is required prior to enrollment.\n6. For patients who underwent radiotherapy (≥ 30% of the bone marrow or wide field) to sites outside the brain, the final dose of radiation must have been administered ≥ 28 days prior to C1D1. For patients who underwent palliative radiotherapy (≤ 30% of the bone marrow or wide field) the final dose of radiation must have been administered ≥14 days prior to C1D1.\n7. Radiologically measurable disease by RECIST v1.1, 4 weeks before C1D1, that can include a lesion in an irradiated field that shows progression according to RECIST v1.1 after irradiation.\n8. Eastern Cooperative Oncology Group (ECOG) 0-1.\n9. Have a life expectancy of \\>12 weeks for disease-related mortality, as evaluated by the INV.\n10. In the opinion of the INV, the patient must be able and willing to understand and give signed informed consent\n11. Women of childbearing potential (WOCBP) who are sexually active with a non-sterilized partner must use at least 1 highly effective method of contraception (with a failure rate of 1% per year) from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of patients of childbearing potential Patients must agree to continue a highly effective contraceptive method, refrain from egg cell donation and breastfeeding while on study treatment and for 5 half-lives plus 6 months after the last dose of study treatment.\n12. Males must use an effective barrier method of contraception without interruption if the patient is sexually active with an WOCBP until the end of exposure, 5 half-lives plus 6 months add-on after the end of treatment. In addition, their female partners who are WOCBP should agree to use 1 highly effective barrier method of contraception at the same time. Male patients should refrain from donating sperm during study participation and for 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n\\-",{"count":20,"type":21},[24,25],"The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are:\n\nTo determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose.\n\nParticipants will:\n\nReceive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms",[58,59,60,61,62,63],"Advanced Solid Tumors","HNSCC","SCLC","NSCLC","TNBC - Triple-Negative Breast Cancer","CRC",[58,61,65],"Head and Neck Cancer","2026-08-12",{"date":68,"type":38},"2026-08-14",{"date":70,"type":38},"2024-12-13",{"date":72,"type":21},"2028-12",{"name":44,"class":45},18,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":83,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100649578","phase-1-study-of-tub-040-given-with-standard-ovarian-cancer-drugs-in-patients-with-fast-growing-ovarian-cancer-100649578","NCT07736937","Study of TUB-040 Given With Standard Ovarian Cancer Drugs in Patients With Fast-growing Ovarian Cancer","A Multicenter, Phase Ib\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Clinical Activity of TUB-040, in Combination With Standard Ovarian Cancer Drugs in Patients With High-grade Epithelial Serous or Endometrioid Epithelial Ovarian Cancer OC)","OC","Inclusion Criteria:\n\n1. Female ≥ 18 years of age at the time of the first screening visit\n2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n3. Histologically confirmed advanced high-grade serous or endometrioid epithelial ovarian, fallopian tube or primary peritoneal cancer.\n4. Have platinum-sensitive ovarian cancer (PSOC) defined as: Patients who had recurrences (radiologically confirmed) to platinum-based therapy and have responded to the last platinum therapy received before study entry and did not progress within 6 months (182 days) of the date of the last dose of platinum-based systemic treatment.\n5. Radiologically measurable disease in at least 1 lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, that can include a lesion in an irradiated field and that shows progression according to RECIST v1.1\n6. Patients must have progressed radiographically on or after their most recent line of anticancer therapy\n7. Adequate hematologic function as indicated by:\n\n   1. Platelet counts ≥100,000\u002Fmm3 (no transfusion or growth factors, e.g., eltrombopag, romiplostim, or IL-11 within 4 weeks before first dose)\n   2. Hemoglobin ≥9.0 g\u002FdL (no transfusion or growth factors e.g. erythropoietin (EPO), darbepoetin within 4 weeks before first dose or long-acting white blood cell growth factors within 20 days before first dose)\n   3. Absolute neutrophil count (ANC) ≥1500\u002FμL (no growth factors, e.g., granulocyte colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF) within 4 weeks before first dose)\n   4. International normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN) in the absence of anticoagulation therapy. If patients are on anticoagulation therapy with a specific INR goal, INR should be within the therapeutic range for the medical indication.\n8. Adequate hepatic function defined as total bilirubin level ≤1.5 × ULN, an aspartate aminotransferase (AST) level ≤2.5 × ULN, and an alanine aminotransferase (ALT) level ≤2.5 × ULN\n\n   1. For documented Gilbert's Syndrome, a total bilirubin \\\u003C3 × ULN is accepted\n   2. For patients with liver metastases, AST and ALT \\\u003C5 × ULN is accepted\n9. Alkaline phosphatase \\\u003C 2.5 x ULN, except if there is an alternative explanation for ALP elevation rather than hepatic failure, such as the presence of bone metastasis\n10. Adequate renal function defined by glomerular filtration rate ≥60 mL\u002Fmin (according to the Chronic Kidney Disease Epidemiology Collaboration, CKD-EPI, formula \\[Appendix B\\]).\n11. Patients must be willing to sign an archival tissue release form for research purposes and determination of biomarker (e.g., NaPi2b) expression. The patient must have an adequate tumor tissue sample available for biomarker assessment by the central laboratory. Mandatory is either a tissue (FFPE) block or a minimum of 6 freshly cut unstained sections based on the most recently available tumor sample. If no archival specimens are available, a new biopsy must be performed. For patients in which a fresh biopsy poses unacceptable clinical risk in the judgment of the treating investigator, enrollment may be considered on a case-by-case basis only after discussion with the Sponsor Medical Monitor.\n12. Resolution of all acute toxic effects of prior therapy or surgical procedures to Grade ≤1 including peripheral neuropathy (except alopecia, hyperpigmentation, or discoloration (incl. vitiligo) of the skin and nails, stable immune-related toxicity such as hypothyroidism on hormone) replacement, corticosteroid treatment on ≤10 mg daily prednisone (or equivalent)\n13. Patients with previous systemic topoisomerase 1 inhibitor treatment (e.g., Topotecan) or patients that are previously treated with ADCs are allowed (except for ADCs with a topoisomerase 1 inhibitor, such as SN38 or other camptothecin derivatives as payload or any ADC targeting NaPi2b)\n14. Completed washout of prior therapy:\n\n    1. Systemic anti-neoplastic therapy: five half-lives or 4 weeks, whichever is shorter prior to first dose of study drug. Hormonal therapy is not considered anti-neoplastic therapy.\n    2. Radiotherapy: last dose ≥ 2 weeks from first dose of study drug\n    3. Completed major surgery at least 4 weeks prior from first dose of study drug and recovered from side effects to Grade ≤1.\n15. Viral infections:\n\n    1. Patients who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B (HBV) anti-viral therapy for at least 4 weeks and have undetectable HBV viral load Note: Patients should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post-completion of study intervention.\n    2. Patients with history of hepatitis C viral (HCV) infection are eligible if HCV viral load is undetectable at screening. Note: Patients must have completed curative anti-viral therapy at least 4 weeks before enrollment\n16. Women of childbearing potential (WOCBP) who are sexually active with a non-sterilized partner must use at least 1 highly effective method of contraception (with a failure rate of ≤1% per year) from the time of screening and must agree to continue using such precautions until the end of exposure, plus at minimum 5 half-lives and 6 months after last dose of either TUB-040, carboplatin, or bevacizumab, whichever is later, in the case of patients of childbearing potential. Abstinence is acceptable only when this is in line with the preferred and usual lifestyle of the patient for the duration of the study treatment and the above-referred period after the end of the exposure. Periodic abstinence (e.g. calendar ovulation, symptom-thermal, post-ovulation methods), the rhythm method, and the withdrawal method are not acceptable methods of contraception.\n\n    Note: A pregnancy test (urine or serum test or per institutional guideline) 72 hours before enrollment is required in WOCBP. Within 72 hours before enrollment, if a positive urine pregnancy test result is confirmed using a serum test, then the patient should not be enrolled into the study. Pregnancy tests (urine or serum test per institutional guideline) should be performed within 72h and resulted prior to the administration of any study treatment, at End of Treatment, and during Follow-Up as mandated by the Schedule of Assessments. In Follow-Up, this is continued monthly for 5-half-lives + 6 months after the last dose of any drug under study, at minimum. Women who have undergone a hysterectomy and\u002For bilateral salpingo-oophorectomy are exempted from testing.\n17. Patients must agree to continue a highly effective contraceptive method, refrain from egg cell donation and breastfeeding while on study treatment and for 5 half-lives plus 6 months after the last dose of study treatment.\n\n    Note: The half-life of TUB-040 is approximately 6 days.\n18. Female patients will be considered post-menopausal if they have undergone bilateral salpingectomy, and\u002For bilateral oophorectomy, and\u002For hysterectomy or have been amenorrheic for 12 months without an alternative medical cause (treatment with antihormonal therapies is considered an alternative medical cause). The following age specific requirements apply:\n\n    1. Women \\\u003C50 years of age will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all hormonal replacement therapy and\u002For if they have luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution.\n    2. Women ≥50 years of age will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all hormonal replacement therapy or had radiation-induced menopause with most recent menses \\>1 year ago or had chemotherapy-induced menopause with most recent menses \\>1 year ago.\n19. In the opinion of the INV, the patient must be able to understand, must be willing to sign informed consent form (ICF) and comply with all study-related procedures, medication use, and evaluations.\n20. Patients must have 1-2 prior lines of systemic platinum therapy and have not progressed within 182 days after the date of the last dose of platinum.\n\n    Notes:\n\n    I. Neoadjuvant ± adjuvant is considered as one line of therapy.\n\n    II. Maintenance therapy (e.g., BEV, poly adenosine diphosphate-ribose polymerase inhibitors (PARPi)) does not count as a line of therapy.\n\n    III. Prior treatment may include BEV\n21. Prior treatment with PARPi is required (for patients who were previously documented to be HRD positive or have a germline or somatic BRCA 1\u002F2 mutation), if PARPi therapy was locally approved at the time of testing.\n\nExclusion Criteria:\n\n1. Patients with clear-cell, mucinous histology, mixed histology with mucinous component, sarcoma, sarcomatous component, or low-grade ovarian cancer\n2. Patients with platinum refractory ovarian cancer (OC) (Platinum refractory is defined as disease that has not responded to a primary platinum-based regimen or progressed within 30 days after primary platinum-based therapy) or platinum resistant ovarian cancer\n3. Patient pregnant, lactating or breastfeeding or having a positive serum pregnancy test during the screening period\n4. Previous systemic topoisomerase-1 inhibitor treatment (except Topotecan)\n5. History of hypersensitivity to monoclonal antibodies, exatecan or excipients of the TUB-040 formulation.\n\n   Note: The excipients of TUB-040 are listed in the IB.\n6. Patients with unresolved malignant bowel obstruction (including patients with radiological findings indicating possible bowel obstruction on CT scans), history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess or Patients on total parenteral nutrition (TPN)\n7. Prior thoracocentesis for therapeutic drainage of malignant effusion \\\u003C 4 weeks from trial inclusion and repeated paracentesis for therapeutic drainage of malignant effusion \\\u003C 4 weeks before trial inclusion\n8. Prior radiotherapy to the pelvis or abdomen (Dose Escalation phase only)\n9. Patients with serum albumin level \\\u003C2,5 g\u002FdL (subjects should not have received IV albumin within 4 weeks of the test)\n10. Participation in interventional clinical studies either concurrently or within the previous 28 days or within 5 half-lives (whichever is shorter) of any investigational pharmacologic agents before study treatment\n11. Patients with untreated spinal cord compression or cerebrovascular accident\u002Fstroke within \\\u003C6 months of enrollment\n12. Major surgery within 21 days prior to signing the ICF, unless the patient is recovered at that time\n13. History of non-infectious ILD\u002Fpneumonitis\u002Fradiation pneumonitis that required steroids or has current ILD\u002Fpneumonitis\n14. Documented cardiac comorbidities: Corrected QT interval \\> 470 msec on the screening ECG, unstable or uncontrolled pectoral angina, myocardial infarction during the last 6 months, valvular heart disease that requires treatment, uncontrollable hypertension (≥Grade 3), uncontrollable arrhythmias, acute myocarditis, or congestive heart failure (CHF) (New York Heart Association III or IV) or severe aortic stenosis\n15. Active, uncontrolled or severe impairment of the urogenital, renal, hepatobiliary (including liver cirrhosis), cardiovascular, respiratory, gastrointestinal, neurologic, or hematopoietic systems which, in the opinion of the INV, would predispose the patient to the development of complications from the administration of protocol therapy\n16. Demyelinating diseases: History of multiple sclerosis or of progressive multifocal leukoencephalopathy\n17. History of another malignancy with ongoing treatment or not yet free from disease for 2 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome.\n18. Any concurrent anti-cancer chemotherapy, radiotherapy (except for local radiation therapy of lesions that may cause imminent complications), hormonal therapy, immunotherapy, or corticosteroid therapy, other than that permitted in Section 8.8.\n19. Live vaccines within 30 days prior to study entry or any known unresolved and active bacterial, viral (e.g. Hep B, Hep C, Varicella or CMV), fungal, mycobacterial, or other infection at screening\n20. History of hypersensitivity to Carbo and risk of further cumulative toxicity with additional platinum, including but not limited to myelosuppression, with febrile neutropenia, Grade 4 hematotoxicity, neuropathy Grade ≥2, renal insufficiency during prior platinum-based therapy\n21. Non-healing wounds, ulcers, or bone fractures\n22. History of posterior reversible encephalopathy syndrome\n23. Recent history of hemoptysis of ≥1\u002F2 teaspoon of red blood within 4 weeks before first study treatment,\n24. History of Grade 4 thromboembolic events\n25. Hypertension ≥ Grade 3 that is not controlled with medical management\n26. Clinically significant proteinuria: urine-protein (UPC) ratio ≥ 1.0 or urine dipstick result ≥ 2+; patients with UPC ratio ≥ 1.0 or ≥ 2+ proteinuria should undergo 24-hour urine collection and must show result \\\u003C 1 gram of protein in 24-hour period.\n27. Any patient who is required to take strong CYP3A4 inhibitors or inducers (see also Prohibited Medication and Guidance for Potential Use section).\n\n    1. Note: If it is clinically acceptable to replace such medication with a different medication which is not a strong CYP3A4 inhibitor or inducer, then the patient may be eligible.","FEMALE",{"count":85,"type":21},72,[24,25],"The goal of this clinical study is to learn more about the safety, tolerability, and preliminary effectiveness of TUB-040 when given in combination with standard ovarian cancer treatments in participants with high-grade epithelial serous or endometrioid ovarian cancer.\n\nThis study will also evaluate the appropriate dose of TUB-040 when used with carboplatin (Carbo) and bevacizumab (BEV), including determining the maximum tolerated dose (MTD) in participants with platinum-sensitive ovarian cancer.",[28],"2026-08-09",{"date":91,"type":38},"2026-08-11",{"date":93,"type":38},"2026-03-30",{"date":95,"type":21},"2028-04",{"name":44,"class":45},8,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":83,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":5},"100650126","phase-1-study-of-tub-040-in-patients-with-recurrent-or-progressive-uterine-cancer-after-chemotherapy-and-immune-therapy-100650126","NCT07743541","Study of TUB-040 in Patients With Recurrent or Progressive Uterine Cancer After Chemotherapy and Immune Therapy","A Multicenter Phase 1\u002F2 Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of the NaPi2B Antibody-Drug Conjugate TUB-040 in Patients With Recurrent or Progressive Uterine Endometrial Cancer After Platinum-Based Chemotherapy and Immune Checkpoint Inhibitor Therapy","NAPISTAR 1-03","Inclusion Criteria:\n\n1. Histologically confirmed advanced recurrent or progressive serous or endometroid endometrial cancer.\n\n   Note: Mixed histologies are allowed if the dominant subtype is serous or endometroid.\n2. Pathological report with results of institutional MMR and\u002For MSI testing.\n3. Received at least 1 but no more than 3 prior lines of anticancer therapy:\n\n   a. Must have received at least 1 line of platinum-based therapy and 1 line of programmed death ligand-1 (PD-L1) or programmed death-1 (PD-1) inhibitor therapy (separately or in combination) Note: Induction plus maintenance is considered as 1 line of therapy. Hormonal therapy without chemotherapy will not be considered a separate line of therapy\n\n   For dose escalation cohorts only:\n\n   The requirement for prior treatment with a PD-1 or PD-L1 inhibitor is waived for patients enrolled in countries where treatment with these agents does not have regulatory approval for first line treatment after discussion with and approval from the Sponsor's medical monitor.\n4. Radiographic progression on or after the most recent line of anticancer therapy.\n5. Female aged ≥ 18 years at the time of consent.\n6. Disease not amenable to curative intent treatment.\n7. Radiologically measurable disease by RECIST v1.1, which can include a lesion in an irradiated field that showed progression by RECIST v1.1 after irradiation.\n8. ECOG performance status of 0 or 1.\n9. Life expectancy \\> 12 weeks for disease-related mortality as evaluated by the INV.\n10. Willing to sign an archival tissue release form for research purposes and determination of biomarker (eg, NaPi2b) expression. An adequate tumor tissue sample, either a formalin-fixed, paraffin-embedded (FFPE) tissue block or a minimum of 6 freshly cut, unstained sections of the most recently available tumor sample, is mandatory for biomarker assessment by the central pathology laboratory. If no archival specimens are available, a newly acquired biopsy specimen must be provided\n11. Willing to undergo a noncontrast high-resolution computed tomography (HRCT) scan of the thorax and pulmonary function testing at screening.\n12. Adequate organ function as defined by all of the following criteria (parameters must be met without growth factor or transfusion support within 4 weeks prior to enrollment):\n\n    1. Aspartate aminotransferase (AST)\u002Fserum glutamic oxaloacetic transaminase and alanine aminotransferase (ALT)\u002Fserum glutamic pyruvate transaminase ≤ 3.0 × the upper limit of normal (ULN)\n    2. Total serum bilirubin ≤ 1.5 × ULN (CTCAE Grade ≤ 1) unless secondary to Gilbert's syndrome. Patients with Gilbert's syndrome may be included if their unconjugated bilirubin is ≤ 3 × ULN.\n    3. Estimated glomerular filtration rate (eGFR) \\> 50 mL\u002Fmin calculated using the Chronic Kidney Disease Epidemiology Collaboration formula (Appendix B)\n    4. Alkaline phosphatase (ALP) \\\u003C 2.5 × ULN, except if there is an alternative explanation for ALP elevation other than hepatic failure, such as the presence of bone metastasis\n    5. Hemoglobin ≥ 9.0 g\u002FdL\n    6. Absolute neutrophil count ≥ 1500\u002Fmm3\n    7. Platelet count ≥ 100,000\u002Fmm3\n    8. International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN in the absence of anticoagulation therapy. If patients are on anticoagulation therapy, INR should be within the therapeutic range for the medical indication\n13. Resolution of all AEs from prior therapy or surgical procedures to Grade ≤ 1 or to baseline (exceptions included alopecia, hyperpigmentation or discoloration of the skin and nails \\[including vitiligo\\], stable immune-related toxicity such as hypothyroidism for patients on hormone replacement or corticosteroid treatment with prednisone, or equivalent, of ≤ 10 mg daily, and Grade 2 peripheral sensory neuropathy after prior treatment with taxane or other anticancer therapy).\n14. Women of childbearing potential (WOCP) must have a negative serum pregnancy test during screening and be neither breastfeeding or intending to become pregnant during study participation. A female will be considered to be of childbearing potential following menarche unless they have undergone permanent sterilization (ie, hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or are postmenopausal. Postmenopausal is defined as at least 12 months without menses with no other medical reason (eg, chemical menopause due to anticancer treatment).\n15. For WOCP, agreement must be provided to use a medically approved, highly effective contraceptive method from the time of screening throughout the study and for 6 months after the last administration of study treatment.\n16. Ability to understand, give written informed consent, comply with all study-related procedures, medication use, and assessments.\n17. No history of noncompliance with medical regimens or considered, in the opinion of the INV, to be potentially unreliable and\u002For uncooperative.\n18. Willing to sign and date the ICF\n\nExclusion Criteria:\n\n1. Unresolved bowel obstruction, including radiographic findings consistent with bowel obstruction plus clinical signs and symptoms of obstruction such as nausea and\u002For vomiting.\n2. Prior thoracocentesis for therapeutic drainage of malignant effusion within 4 weeks prior to initiation of study treatment.\n3. Paracentesis for therapeutic drainage of malignant effusion within 4 weeks prior to initiation of study treatment.\n4. Receiving total parenteral nutrition.\n5. Serum albumin \\\u003C 2.5 g\u002FdL (patients should not receive IV albumin within 4 weeks prior to testing).\n6. Known active central nervous system metastases and\u002For carcinomatous meningitis. Note: Previously treated brain metastases allowed if follow-up brain imaging after CNS directed therapy shows no evidence of progression, and they have been off steroids for \\> 4 weeks prior to first dose.\n7. Pregnant, lactating, or breastfeeding.\n8. History of hypersensitivity to exatecan or excipients of the TUB-040 formulation.\n9. Prior treatment with an ADC-containing Topo-1 inhibitor payload. ADCs with other payloads are allowed (eg, monomethyl auristatin E, monomethyl auristatin F).\n10. Discontinuation of the most recent systemic anticancer therapy due to hematologic toxicity.\n11. Participation in any interventional clinical studies either concurrently or within 28 days or 5 half-lives (whichever is shorter) prior to enrollment of any investigational pharmacologic agent, imaging materials, including dyes, investigational surgical techniques, or devices.\n12. Chemotherapy or other anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to initiation of study treatment.\n13. Radiotherapy \\\u003C 2 weeks prior to enrollment. Patients with wide-field radiotherapy (\\> 30% of marrow-bearing bone) must not have had treatment within 4 weeks prior to initiation of study treatment.\n14. Major surgery within 21 days prior to signing ICF unless the patient has recovered at that time.\n\n    Note: Major surgery involves opening of a body cavity such as the thorax or abdomen. A lymph node or skin biopsy is not considered major surgery. Minor surgical procedures such as central venous catheter placement, tumor biopsy, and feeding tube placement are not considered major.\n15. Active ILD\u002Fpneumonitis or history of noninfectious ILD\u002Fpneumonitis\u002Fradiation pneumonitis that required steroid treatment.\n16. Oxygen saturation of \\\u003C 93% on room air at rest\n17. Resting QTcF \\> 470 msec. If a single QTcF is \\> 470 msec, the patient may enroll if the mean QTcF from 3 electrocardiograms (ECGs) is \\\u003C 470 msec.\n18. History of nephrotic syndrome or proteinuria Grade ≥ 2.\n19. Active corneal disease, or history of corneal disease within 4 months prior to enrollment.\n20. Active, uncontrolled or severe impairment of the urogenital, renal, hepatobiliary, cardiovascular, respiratory, gastrointestinal, neurologic, or hematopoietic systems which, in the opinion of the INV, would predispose the patient to the development of complications from the administration of protocol therapy.\n21. History of another malignancy with ongoing treatment or not yet free from disease for 2 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome.\n22. Documented other concurrent nonmalignant comorbidities such as unstable or uncontrolled pectoral angina, myocardial infarction during the last 6 months, valvular heart disease that requires treatment, acute myocarditis, or congestive heart failure (New York Heart Association III or IV).\n23. Any concurrent anticancer chemotherapy, radiotherapy (palliative radiation may be permitted after approval by the sponsor in accordance with protocol), hormonal therapy, immunotherapy, corticosteroid therapy other than that permitted in protocol), or any other prohibited medications as listed in protocol.\n24. Live vaccines within 30 days prior to study enrollment.\n25. Concomitant use of strong inhibitors or strong inducers of cytochrome P450 (CYP)3A4.\n26. For Phase 1 only: Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure with reduced ejection fraction or severe diastolic dysfunction, potential for torsades de pointes, congenital long QT syndrome.\n27. Positive for hepatitis B surface antigen (HbsAg) or hepatitis B (HBV) DNA.\n28. Active acute or chronic infection.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":107,"type":21},100,[24,25],"The goal of this clinical study is to learn more about the study drug TUB-040, safety, tolerability, pharmacokinetics (PK), and effectiveness in treating patients with recurrent or progressive uterine endometrial cancer after platinum-based chemotherapy and immune checkpoint inhibitor therapy.\n\nThe primary objectives of Phase 1 of this study are to determine the safety and tolerability of TUB-040 and determine the maximum tolerated dose (MTD) and\u002For recommended Phase 2 dose (RP2D).\n\nThe primary objective of Phase 2 of this study is to evaluate the efficacy of TUB-040 monotherapy at the RP2D in endometrial cancer.",[111],"Uterine Endometrial Cancer",[113,114],"Recurrent Endometrial Cancer","Progressive Endometrial Cancer","NOT_YET_RECRUITING","2026-08-03",{"date":118,"type":38},"2026-08-05",{"date":120,"type":21},"2026-10",{"date":122,"type":21},"2029-09",{"name":44,"class":45},""]