[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ovarian-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ovarian-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,427,0,25,[9,43,84,106,125,153,176,200,221,248,268,292,319,350,380,408,439,468,488,513,543,567,592,612,634],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100617433","phase-3-a-clinical-trial-of-sac-tmt-in-people-with-non-hrd-positive-advanced-ovarian-cancer-mk-2870-021-100617433",false,"NCT07318558","A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)","A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021\u002FENGOTov85\u002FGOG-3102)","TroFuse-021","The main inclusion criteria include but are not limited to the following:\n\n* Has diagnosis of FIGO 2014 Stage III or Stage IV, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with one of the following histologies: high-grade serous, high-grade endometrioid, clear cell carcinoma, or malignant mixed Müllerian tumour with a high-grade serous component. Tumors reported as Grade 2 may be enrolled only if predominately (\\>50%) Grade 3 features are present.\n* Has completed primary debulking surgery or interval debulking surgery.\n* Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol.\n* Has provided tumor tissue that is not previously irradiated.\n* Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if diagnosed with HIV\n* Has undetectable hepatitis B virus (HBV) viral load and received HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.\n* Has undetectable hepatitis C virus (HCV) viral load if has a history of HCV infection.\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has nonepithelial cancers, low-grade serous tumors, low-grade endometrioid tumors, borderline tumors mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Has a history of severe eye disease.\n* Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease.\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD), which required steroids, has current pneumonitis\u002FILD, or has suspected ILD, or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening.\n* Received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria.\n* Had a live or live-attenuated vaccine within 30 days of randomization.\n* Has a known additional malignancy that is progressing or required active treatment within the past 3 years.\n* Has active infection requiring systemic therapy.\n* Has concurrent and active HBV and HCV infections.\n* Has HIV infection and a history of Kaposi's sarcoma and\u002For multicentric Castleman's disease.\n* Has not recovered from major surgery or has ongoing surgical complications.\n* Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory.\n* Active or ongoing stomatitis of any grade.","FEMALE","18 Years",{"count":21,"type":22},900,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include:\n\n* Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread.\n* Observation, which is watching to see if cancer grows or worsens\n\nThe study medicine, sacituzumab tirumotecan (also called sac-TMT), is a targeted therapy. The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.",[28,29],"Ovarian Neoplasms","Ovarian Cancer","RECRUITING","2026-08-20",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":34},"2026-02-16",{"date":38,"type":22},"2033-02-25",{"name":40,"class":41},"Merck Sharp & Dohme LLC","INDUSTRY",155,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100500508","phase-1-phase-iiia-study-of-azd5335-as-monotherapy-and-combination-therapy-in-participants-with-solid-tumors-100500508","NCT05797168","Phase I\u002FIIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors","A Modular Phase I\u002FIIa, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD5335 Monotherapy and in Combination With Anti-cancer Agents in Participants With Solid Tumors","FONTANA","Core Inclusion Criteria:\n\n* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n* Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative. Participants who do not provide informed consent for Optional Genetic Research may still be enrolled in the study.\n* Participant must be ≥ 18 years at the time of signing the informed consent.\n* Willing to provide adequate archival and\u002For baseline tumor sample as applicable per module-specific criteria.\n* For participants who have previously received targeted therapies such as ADCs, a fresh baseline biopsy will be required unless the most recent archival tissue sample was collected after receipt of such treatment.\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Participants with advanced solid tumors must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease, or, in the opinion of the Investigator, a clinical trial is the best option for the next treatment based on response and\u002For tolerability to prior therapy. Participants with contraindications or who refuse therapy in accordance with local practice may also be considered provided that it is documented that he\u002Fshe was informed about all therapeutic options.\n* Participants must have measurable disease per RECIST v1.1,\n\n  1. A previously irradiated lesion can be considered a target lesion if the lesion is progressing and well defined.\n  2. For participants who undergo biopsies at screening and\u002For on treatment, it is preferred though not required, that the biopsied lesion, be distinct from any target lesion used in the RECIST v1.1 evaluation.\n* Life expectancy ≥ 12 weeks.\n* Adequate organ and marrow function.\n* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n  (a) Male participants: (i) Male participants who are sexually active with a female partner of childbearing potential must use a male condom (plus an additional contraceptive method) post-screening for at least 8 months following the last dose of study intervention. It is strongly recommended for the female partner of a male participant to also use a highly effective method of contraception throughout this period. In addition, male participants must refrain from freezing or donating sperm while on study and for 8 months following the last dose of study intervention.\n\n  (b) Female participants : (i) Females of childbearing potential must have a negative serum pregnancy test result within 72 hours prior to receiving the first dose of study intervention and a negative urine or serum pregnancy test prior to starting their next cycle of treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n(ii) (ii) Sex and Contraceptive\u002FBarrier Requirements: Highly effective birth control methods include: Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the participant (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments) \\[(periodic abstinence e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to study intervention, and withdrawal are not acceptable methods of contraception\\], a vasectomized partner, Implanon®, bilateral tubal occlusion, intrauterine device\u002Flevonorgestrel intrauterine system, Depo Provera™ injections, oral contraceptive associated with inhibition of ovulation, and Evra Patch™, Xulane™, or NuvaRing®.\n\nFemale participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use one highly effective method of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly), from enrolment throughout the study and for 8 months following the last dose of study intervention. The male partner of a female participant of childbearing potential must also use a male condom (plus spermicide, if available) throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. In addition, female participants must not donate or retrieve for their own use, ova while on study and for 8 months following the last dose of study intervention.\n\nCore Exclusion Criteria:\n\n* Patients with spinal cord compression or a history of leptomeningeal carcinomatosis.\n* Patients with brain metastases unless, asymptomatic, stable, and not requiring continuous corticosteroids at a dose of \\> 10 mg prednisone\u002Fday or equivalent for at least 4 weeks prior to first dose of study intervention.\n* Treatment with any of the protocol defined medications, without adequate washout periods or time before the first dose of study intervention.\n* Unresolved toxicities of Grade ≥ 2 (National Cancer Institute \\[NCI\\] CTCAE v5.0) from prior therapy (excluding vitiligo, alopecia, and endocrine disorders that are controlled with replacement hormone therapy). Participants with stable ≤ Grade 2 neuropathy are eligible.\n* Active infection, including tuberculosis and infections with hepatitis B virus (HBV; verified by known positive hepatitis B surface antigen \\[HBsAg\\] result), hepatitis C virus (HCV) or known HIV infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, CD4+ count ≥ 350\u002Fmm3, no history of acquired immune deficiency syndrome-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen).\n\nPatients with a past or resolved HBV\u002FHCV infection are eligible if:\n\n1. Negative for HBsAg and positive for anti-hepatitis B virus core protein (HBc) or\n2. Are HBsAg + with chronic HBV infection (lasting 6 months or longer) and meet conditions i-iii below:\n\n(i) HBV DNA viral load \\\u003C100 IU\u002FmL. (ii) Have normal transaminase values, or, if liver metastases are present, abnormal transaminases, with a result of aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\\u003C3 x upper limit of normal (ULN), which are not attributable to HBV infection.\n\n(iii) Start or maintain antiviral treatment if clinically indicated as per the Investigator or as per local guideline.\n\nNote for Japan: Japanese patients with positive anti-HBs\u002Fanti-HBc and negative HBsAg will be assessed following local guidelines.\n\n(c) Participants testing positive for HCV antibody are eligible only if the polymerase chain reaction test result is negative for HCV RNA.\n\n* Patient has active ILD\u002Fpneumonitis or has a history of (non-infectious) ILD\u002Fpneumonitis that required oral or IV steroids or supplemental oxygen, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n\n  * Patients with a history of radiation pneumonitis which has clinically and radiologically resolved and not requiring treatment with steroids may be eligible.\n* History of another malignancy except for:\n\n  * Malignancy treated with curative intent and with no known active disease for at least 2 years prior to screening of study intervention and with low potential risk for recurrence.\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n  * Adequately treated carcinoma in situ without evidence of disease.\n  * Localized non-invasive solid organ primary disease under surveillance.\n* Patients with any of the following cardiac criteria:\n\n  * History of arrhythmia (such as multifocal premature ventricular contractions, bigeminy, trigeminy, and ventricular tachycardia), which is symptomatic or requires treatment NCI CTCAE v5.0 Grade 3 except for:\n\n    (i) Rate controlled asymptomatic atrial fibrillation.\n    * NOTE: significant abnormalities in serum electrolytes that can increase the risk of arrhythmic events (ie, sodium, potassium, calcium, and magnesium) should be corrected before starting the study intervention.\n  * Uncontrolled hypertension.\n  * Acute coronary syndrome\u002Facute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention, or coronary artery bypass grafting within 6 months of screening.\n  * History of brain perfusion problems (eg, carotid stenosis) or stroke, or transient ischemic attack in the last 6 months prior to screening.\n  * Symptomatic heart failure (as defined by New York Heart Association class ≥ 2).\n  * Prior or current diagnosis of cardiomyopathy considered clinically relevant per investigator's judgement.\n  * Severe uncorrected valvular heart disease.\n  * Mean resting QTcF \\> 470 msec obtained from triplicate electrocardiograms (ECGs) and averaged, recorded within 5 minutes.\n  * Any factor that, in the opinion of the investigator, increases the proarrhythmic risk of QT prolongation, such as congenital long QT syndrome, family history of long QT syndrome, hypertrophic cardiomyopathy, or unexplained sudden cardiac death under 40 years of age.\n* Uncontrolled and\u002For unresolved intercurrent illness within 12 months prior to screening, including but not limited to serious chronic gastrointestinal conditions associated with diarrhea, or illness (including psychiatric illness) and\u002For social situations, in the opinion of the investigator, that would limit compliance with study requirements and activities, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent.\n* Substance abuse or any other medical conditions that would increase the safety risk to the participant or interfere with participation of the participant or evaluation of the clinical study in the opinion of the Investigator.\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Participants, if enrolled, should not receive live vaccine whilst receiving study intervention and up to 3 months after the last dose of study intervention. Participants can receive Coronavirus (COVID)-19 vaccines, at the discretion of the Investigator, following a benefit\u002Frisk evaluation for the individual participant and in accordance with local rules and regulations and vaccination guidelines. Note: If a COVID-19 vaccine is administered it should be done \\> 72 hours prior to study intervention initiation or after completion of the DLT period.\n* For women only - currently pregnant (confirmed with positive pregnancy test or suspected), lactating, breastfeeding, or intention to become pregnant during the study period.\n* Concurrent enrolment in another clinical study, unless it is an observational (non interventional) clinical study or during the follow-up period of an interventional study. Exception: Diagnostic imaging evaluation studies (e.g. PET) may be allowed subject to case-by-case discussion with the Sponsor.\n* Patients with a known hypersensitivity to study intervention or any of the excipients of the product.\n* Involvement in the planning and\u002For conduct of the study (applies to both AstraZeneca staff and\u002For staff at the study site).\n* Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.\n* Previous enrolment in the present study. \\*\\*Other module specific criteria may apply","ALL","130 Years",{"count":54,"type":22},602,[56,57],"PHASE1","PHASE2","This research is designed to determine if experimental treatment with Antibody-drug conjugate, AZD5335, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced tumors",[29,60,61,62],"Lung Adenocarcinoma","Endometrial Cancer","Lung Squamous Cell Carcinoma",[64,65,66,67,68,69,70,71,72,73,74,75,29,60,61,62],"ADC","PARP inhibitor","AZD5335","Torvutatug Samrotecan","Torvu-sam","AZD5305","Saruparib","Bevacizumab","Carboplatin","AZD9574","Palacaparib","Pembrolizumab",{"date":33,"type":34},{"date":78,"type":34},"2023-06-05",{"date":80,"type":22},"2028-08-04",{"name":82,"class":41},"AstraZeneca",60,{"id":85,"slug":86,"hasResults":12,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100652811","phase-3-clinical-trials-comparing-trastuzumab-plus-bevacizumab-with-bevacizumab-as-first-line-maintenance-therapy-for-epithelial-ovarian-cancer-100652811","NCT07779538","Clinical Trials Comparing Trastuzumab Plus Bevacizumab With Bevacizumab as First-line Maintenance Therapy for Epithelial Ovarian Cancer","A Randomized, Open-label, Multicenter Phase Ib\u002FIII Clinical Trial Comparing Trastuzumab Plus Bevacizumab With Bevacizumab as First-line Maintenance Therapy for Epithelial Ovarian Cancer","Inclusion Criteria:\n\n1. Participants voluntarily join this trial and sign an informed consent form.\n2. Newly diagnosed stage III or IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, confirmed by histological or cytological pathology.\n3. Prior to first-line platinum-based doublet chemotherapy combined with bevacizumab.\n4. No disease progression as assessed by the investigator after completion of first-line platinum-based therapy and before randomization.\n5. Participants' homologous recombination deficiency test results must meet the criteria.\n6. Participants have not received any anti-tumor therapy from the last dose of first-line platinum-based therapy until randomization.\n7. Able to provide sufficient fresh or archived tumor tissue specimens for testing at the sponsor-designated central laboratory.\n8. ECOG PS score: 0-1.\n9. Expected survival ≥ 12 weeks.\n10. Laboratory tests within 7 days prior to randomization confirm that important organ function meets the requirements.\n11. Female participants of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to randomization and must not be breastfeeding; female participants of childbearing potential must agree to adhere to contraception from the date of signing the informed consent form until 7 months after the last dose.\n\nExclusion Criteria:\n\n1. Participants with untreated or active central nervous system (CNS) metastases; a history of meningeal metastases or current meningeal metastases.\n2. Participants with clinically symptomatic, poorly controlled, or moderate to severe pleural effusion, pericardial effusion, or ascites.\n3. Participants with a history of or concurrent other malignancies, excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and other malignancies that have been adequately treated and cured for ≥5 years prior to randomization with evidence of no recurrence or metastasis.\n4. Participants with a history of interstitial pneumonia\u002Finterstitial lung disease requiring steroid treatment, non-infectious pneumonia (such as radiation pneumonitis), current or suspected interstitial pneumonia\u002Finterstitial lung disease, non-infectious pneumonia, or other active pneumonia; or those with severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, or other lung damage within 6 months prior to randomization.\n5. 6\\. Individuals with active pulmonary tuberculosis; those who have received adequate and regular treatment and have stopped anti-tuberculosis treatment for ≥3 months prior to randomization are eligible for enrollment.\n\n7\\. Individuals with poorly controlled or severe cardiovascular disease. 8. Individuals who have experienced arterial\u002Fvenous thrombotic events within 6 months prior to randomization.\n\n9\\. Individuals who have experienced NCI-CTCAE v6.0 grade ≥2 bleeding events within 1 month prior to randomization.\n\n10\\. Individuals with known hereditary or acquired bleeding (e.g., coagulation disorders) or thrombotic tendency.\n\n11\\. Individuals who have experienced or are expected to experience gastrointestinal perforation or fistula, tracheal fistula, urethral fistula, or abdominal abscess in the near future.\n\n12\\. Individuals with gastrointestinal obstruction or symptoms and signs of gastrointestinal obstruction within 3 months prior to randomization; individuals who have previously undergone intestinal stent implantation and whose intestinal stent has not been removed by the screening period.\n\n13\\. Participants who have experienced severe infection within 1 month prior to randomization.\n\n14\\. Participants who have tested positive for human immunodeficiency virus (HIV); participants with known active hepatitis.\n\n15\\. Participants who have undergone major surgery within 4 weeks prior to randomization or whose surgical side effects have not recovered or stabilized prior to randomization. 16. Patients who may receive other systemic anti-tumor therapies during treatment or are scheduled for further debulking surgery.\n\n17\\. Patients whose toxicity from previous anti-tumor therapy has not recovered to grade ≤1 according to the NCI-CTCAE v6.0 classification.\n\n18\\. Patients with known hypersensitivity to any component of the SHR-A1811 product or other monoclonal antibody drugs.\n\n19\\. Patients who, in the investigator's judgment, have other factors that may affect the trial results or force the trial to be terminated midway, such as alcoholism, drug abuse, substance abuse, criminal detention, etc., as well as other serious illnesses (including mental illness) requiring concomitant treatment, serious abnormal laboratory test results, or any other circumstances that may increase the risk of participation in the trial, interfere with the trial results, or make them unsuitable for participation in the trial.",{"count":92,"type":22},420,[25],"This trial is a randomized, open-label, positive-controlled, multicenter phase Ib\u002FIII clinical trial, divided into two phases. Phase Ib aims to evaluate the safety and tolerability of SHR-A1811 in combination with bevacizumab as first-line maintenance therapy in participants with epithelial ovarian cancer without pathological progression (PD) after first-line platinum-based doublet chemotherapy plus bevacizumab (hereinafter referred to as \"platinum-based triple therapy\"). Phase III aims to evaluate the efficacy and safety of SHR-A1811 in combination with bevacizumab versus bevacizumab as maintenance therapy in participants with epithelial ovarian cancer without PD after first-line platinum-based triple therapy.",[29],"NOT_YET_RECRUITING","2026-08-19",{"date":33,"type":34},{"date":100,"type":22},"2026-09-01",{"date":102,"type":22},"2030-05-30",{"name":104,"class":41},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.",3,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":4},"100652788","phase-1-a-phase-iii-first-in-human-study-to-evaluate-tj102-in-participants-with-advanced-or-metastatic-ovarian-cancer-and-other-solid-tumors-100652788","NCT07778498","A Phase I\u002FII, First-in-Human Study to Evaluate TJ102 in Participants With Advanced or Metastatic Ovarian Cancer and Other Solid Tumors.","A Phase I\u002FII, First-in-Human, Open-Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy, and Immunogenicity of TJ102 in Participants With Advanced or Metastatic Ovarian Cancer and Other Solid Tumors.","Main Inclusion Criteria:\n\n1. Has histologically or cytologically documented locally advanced or metastatic high-grade serous epithelial ovarian cancer, including ovarian, fallopian tube, or primary peritoneal carcinoma, that is not amenable to curative surgery or radiotherapy, and has demonstrated radiographic disease progression on the most recent line of systemic therapy.\n2. Prior exposure to a platinum-containing regimen is mandatory. Platinum-resistant disease is defined as disease progression during or within 6 months following completion of the most recent platinum-containing regimen. Patients with platinum-sensitive disease may be eligible during Phase 1 if they have received at least 2 prior lines of platinum-containing systemic therapy.\n3. Prior Lines of therapy:\n\n   Subjects must have received at least one (≥1) and no more than four (≤4) prior lines of systemic therapy in the advanced or metastatic setting and have progressed on, been intolerant to, or be ineligible for standard therapies available in their local region. Prior treatment with mirvetuximab soravtansine and\u002For bevacizumab is permitted but not required, reflecting regional differences in standard of care, regulatory approval status, availability, or access.\n\n   Hormonal therapy and maintenance therapy, including PARP inhibitors or bevacizumab maintenance, are not counted as prior lines of systemic therapy unless administered for treatment of progressive disease.\n4. Have at least one measurable lesion by RECIST v1.1 (Eisenhauer et al., 2009) for solid tumors;\n5. ≥18 years old;\n6. Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) of 0 to 1;\n7. Life expectancy of ≥12 weeks;\n8. Patients with adequate organ function and the laboratory test criteria specifically defined as follows within 7 days prior to the first dosing;\n\nMain Exclusion Criteria:\n\n1. Has know hypersensitivity to any component of TJ102 or has a history of severe hypersensitivity reactions to other monoclonal antibodies.\n2. Has received more than two (2) prior antibody-drug conjugate (ADC) therapies in the advanced or metastatic disease setting, including ADCs containing topoisomerase I inhibitor payloads (e.g., SN-38, DXd, exatecan derivatives) or antimicrotubule payloads (e.g., MMAE, DM1\u002FDM4, auristatins, maytansinoids).\n3. Prior therapy with any antibody-drug conjugate (ADC) whose cytotoxic payload is eribulin or a structural derivative thereof is prohibited in the advanced\u002Fmetastatic disease setting.\n4. Has received mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil-like drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks prior to the first administration; Has received other chemotherapy, biological therapy, major surgery, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase) and other anti-tumor therapy within 5 half-lives or 28 days, whichever is shorter, prior to the first administration of TJ102; Has received anti-tumor herbal medicine within 14 days prior to first dose of TJ102;\n5. Has received a strong or moderate CYP3A4 inhibitor within 3 half-lives prior to first dose of TJ102;\n6. Received an investigational drug within 28 days or 2 half-lives (whichever is shorter) prior to first dose of TJ102; Current participation in other interventional clinical studies (participation in survival follow-up is allowed);\n7. Toxic effects of prior anti-tumor therapy have not recovered to NCI-CTCAE V6.0 Grade ≤1 (excluding alopecia and skin pigmentation). Subject with irreversible toxicities caused by prior anti-tumor therapy (eg, hearing loss) that will not increase the safety risk may be eligible per the discretion of the Investigator;\n8. Has a history of (non-infectious) interstitial lung disease (ILD) that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis can't be ruled out by imaging at screening;\n9. Presence of severe dry eye syndrome, severe keratitis, severe conjunctivitis, or other severe conditions that may increase the risk of corneal epithelial damage at the discretion of investigator;\n10. Presence of Grade ≥2 or history of Grade ≥3 peripheral neuropathy.\n11. Uncontrolled or significant cardiovascular disease\n12. For patients with documented positive virology status, as confirmed by Screening hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) tests, only the following patients may be eligible as evaluated by the sponsor and investigator:\n\n    Patients with active hepatitis B: HBV DNA ≤500 IU\u002FmL during Screening. Patients who are hepatitis C virus antibody positive (HCV Ab+), should have controlled infection (HCV RNA≤ULN by polymerase chain reaction \\[PCR\\] either spontaneously or in response to a successful prior course of anti-HCV therapy at Screening). Patients with controlled infections must undergo periodic monitoring of HCV RNA as per treating physician.\n13. Severe infection, including but not limited to hospitalization due to infection, bacteraemia, or severe pneumonia complications, occurs within 4 weeks prior to initiation of study treatment; Or patients who received therapeutic oral or intravenous antibiotics and who received prophylactic antibiotics (e.g., for the prevention of urinary tract infection or chronic obstructive pulmonary disease) within two weeks prior to starting study treatment.\n14. Active central nervous system (CNS) metastases or meningeal metastases. Subjects may be enrolled in the study if their CNS metastases have received adequate local therapy and have been clinical stable for at least 4 weeks (i.e., imaging shows no progression of the brain lesion and neurologically relevant symptoms are stable), and require a dose of prednisone of ≤20 mg\u002Fday (or equivalent dose). Subjects with untreated CNS metastases are excluded.\n15. Other malignancies within 3 years prior to initiation of study treatment (Note: does not include tumors with a negligible risk for metastasis or death, eg, non-melanoma basal cell carcinoma or squamous cell carcinoma of the skin, breast\u002Fcervical carcinoma in situ, superficial bladder carcinoma that have received radical treatment and without evidence of disease recurrence);\n16. Female patients who are lactating or breastfeeding;\n17. The investigator believes that the subject may have other factors that may affect the results of the study and interfere with the subject's participation in the entire study process, including previous or existing physical conditions, abnormal treatment or laboratory tests, and the subject's unwillingness to comply with all procedures, restrictions, and requirements of the study.",{"count":114,"type":22},150,[56,57],"The goal of this clinical trial is to evaluate whether TJ102, an investigational antibody-drug conjugate (ADC), can safely and effectively treat patients with advanced ovarian or other solid tumors. The main objectives of this study are : • To Determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) of TJ102 • to show preliminary antitumor activity in patients with advanced ovarian or other solid tumors. Participants will: • Receive intravenous (IV) infusions of TJ102 at escalating dose levels (during dose escalation) or at the selected expansion dose. • Undergo regular tumor imaging to assess response. • Provide blood samples for pharmacokinetics (PK) and biomarker analysis. • Be monitored for side effects and overall tolerability. This study is being conducted in adult patients with advanced or metastatic ovarian or other solid tumors who have exhausted standard treatment options.",[29],{"date":33,"type":34},{"date":120,"type":22},"2026-09-15",{"date":122,"type":22},"2030-09",{"name":124,"class":41},"Phrontline Biopharma",{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":134,"conditions":135,"keywords":141,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100601379","phase-1-a-phase-12-trial-of-ter-2013-in-patients-with-solid-tumors-harboring-aktpi3kpten-pathway-alterations-100601379","NCT07109726","A Phase 1\u002F2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT\u002FPI3K\u002FPTEN Pathway Alterations","Key Inclusion Criteria\n\n* Metastatic or locally advanced, unresectable disease\n* No available treatment with curative intent\n* Presence of lesions to be evaluated per RECIST v1.1:\n\n  a. Dose Escalation: measurable or evaluable disease b. Cohort Expansion: measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate organ function\n* Advanced solid tumor malignancy harboring an eligible AKT\u002FPI3K\u002FPTEN pathway alteration detected by a sponsor approved test\n\nKey Inclusion Criteria for TER-2013 monotherapy arms:\n\n* Histologically confirmed diagnosis of:\n\n  a. \\[For TER-2013 dose escalation\\]: solid tumor malignancy b. \\[For TER-2013 cohort expansion\\]: i. Cohort 1: ovarian cancer, cervical cancer, or squamous cell carcinoma of the head and neck, lung, or esophagus ii. Cohort 2: endometrial adenocarcinoma\n* Prior therapy:\n\n  1. \\[For TER-2013 dose escalation\\]: Received standard therapies appropriate for their tumor type and stage, unless contraindicated, intolerable, or patient refused\n  2. \\[For TER-2013 cohort expansion\\]: No more than 3 prior lines of treatment in the advanced setting\n\n     Key Inclusion Criteria for TER-2013 and fulvestrant combination arms\n* Histologically confirmed diagnosis of:\n\n  a. \\[For TER-2013 + fulvestrant dose escalation\\]: HR+\u002FHER2- advanced unresectable or metastatic breast cancer b. \\[For TER-2013 + fulvestrant cohort expansion\\]: i. Received treatment with an AI containing regimen (single agent or in combination) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting\n* Prior Therapy:\n\n  a. \\[For TER-2013 + fulvestrant dose escalation\\]: Received treatment with an AI containing regimen (single agent or in combination) b. \\[For TER-2013 + fulvestrant cohort expansion\\]: i. Received treatment with an AI containing regimen (single agent or in combination) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting\n\nKey Exclusion Criteria:\n\n* Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K\u002FAKT\u002FPTEN alteration\n* Clinically significant abnormalities of glucose metabolism\n* Active brain metastases or carcinomatous meningitis.\n* History of significant hemoptysis or hemorrhage within 4 weeks prior to first dose of study drug\n* Malabsorption syndrome, nausea and vomiting uncontrolled by medication, or disease significantly affecting gastrointestinal function likely to interfere with the delivery, absorption, or metabolism of TER-2013\n* Prior therapy:\n\n  1. \\[For TER-2013 monotherapy escalation\\]: AKT inhibitor\n  2. \\[For TER-2013 monotherapy expansion\\]: AKT\u002FPI3K\u002FPTEN pathway inhibitor\n  3. \\[For TER-2013 + fulvestrant combination expansion\\]: AKT\u002FPI3K\u002FPTEN pathway inhibitor, fulvestrant and other SERDs, mTOR inhibitor; some PIK3CA-altered cohorts allow prior PI3K inhibitor.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria apply",{"count":132,"type":22},205,[56,57],"This is a Phase 1\u002F2, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TER-2013 in patients with advanced solid tumors harboring AKT\u002FPI3K\u002FPTEN pathway alterations.",[136,61,29,62,137,138,139,140],"Breast Cancer","Head and Neck Squamous Cell Carcinoma","Esophageal Squamous Cell Carcinoma","Solid Tumor","Cervical Cancer",[142,136,143,144],"AKT\u002FPI3K\u002FPTEN Alterations","Advanced Solid Tumors","HR+\u002FHER2-",{"date":33,"type":34},{"date":147,"type":34},"2025-09-23",{"date":149,"type":22},"2029-02-28",{"name":151,"class":41},"Terremoto Biosciences Inc.",18,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":23,"phases":163,"briefSummary":164,"conditions":165,"keywords":166,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":175},"100597542","phase-2-a-study-to-assess-adverse-events-and-change-in-disease-activity-of-multiple-treatment-combinations-with-intravenous-mirvetuximab-soravtansine-in-adult-participants-with-ovarian-cancer-100597542","NCT07059845","A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer","A Phase 2, Open-Label, Randomized, Master Protocol Dose Optimization Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Mirvetuximab Soravtansine in Subjects With Ovarian Cancer","FLORENZA","Inclusion Criteria:\n\nSubstudy 1\n\n* Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \\>= 50% of viable tumor cells with \\>= 2+ staining intensity.\n* Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.\n* 1L participants must have a confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) Stage III or IV high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.\n\n  2L participants must have platinum-sensitive high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of most recent platinumbased chemotherapy. Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression.\n* Participant has a local homologous recombination deficient (HRD) or breast cancer susceptibility gene (BRCA) test result available. Participants with BRCA wild-type will need to have a local HRD test result available.\n\nSubstudy 2\n\n* Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \\>= 50% of viable tumor cells with \\>= 2+ staining intensity.\n* Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.\n* Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.\n* Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy.\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.\n\nSubstudy 3\n\n* Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \\>= 50% of viable tumor cells with \\>= 2+ staining intensity.\n* Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.\n* Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.\n* Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy.\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.\n\nExclusion Criteria:\n\nSubstudy 1\n\n* Participants with progressive disease (PD) while on triplet therapy or after the first day of their last triplet therapy cycle and before randomization.\n* Participants who receive an intervening dose of bevacizumab after the first day of their last triplet therapy cycle and before randomization.\n* Participants who received prior treatment with mirvetuximab soravtansine (MIRV), any FRα-targeting agent, or Poly(ADP-ribose) polymerase inhibitor (PARPi).\n\nSubstudy 2\n\n* More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:\n\n  * Neoadjuvant +\u002F- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.\n  * Maintenance therapy (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently).\n  * If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy\n  * Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen)\n* Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.\n\nSubstudy 3\n\n* More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:\n\n  * Neoadjuvant +\u002F- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.\n  * Maintenance therapy (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently).\n  * If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy\n  * Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen)\n* Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.",{"count":162,"type":22},400,[57],"Ovarian cancer is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC). Participants must have confirmation of folate receptor alpha (FRa) positivity by the Ventana folate receptor 1 (FOLR1) Assay.\n\nMirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 3 substudies and further into groups called treatment arms. In substudy 1, arms A-C, participants will receive 1 of 2 doses of MIRV with Bev, or Bev alone. In substudy 2, arms D and E, participants will receive 1 of 2 doses of MIRV with carboplatin, followed by MIRV alone. In substudy 3, arms F and G, participants will receive one of two doses of MIRV with BEV and carboplatin, followed by MIRV with BEV. Approximately 400 participants will be enrolled in the study at 100 sites around the world.\n\nParticipants will receive intravenously (IV) infused MIRV with IV infused carboplatin, or IV infused Bev, or IV infused carboplatin and Bev, or IV infused Bev alone. The total study duration will be approximately 40 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.",[29],[29,167,71,72],"Mirvetuximab Soravtansine",{"date":33,"type":34},{"date":170,"type":34},"2025-11-13",{"date":172,"type":22},"2029-01",{"name":174,"class":41},"AbbVie",83,{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":199},"100575644","phase-1-a-phase-1-study-of-lncb74-in-advanced-solid-tumors-100575644","NCT06774963","A Phase 1 Study of LNCB74 in Advanced Solid Tumors","A Phase 1, Open-label, Dose Escalation and Dose Expansion Study for LNCB74, a B7-H4 Targeted Antibody Drug Conjugate, as Monotherapy in Participants With Advanced Solid Tumors","LNCB74-01","Inclusion Criteria:\n\n1. The participant provides written informed consent\n2. ≥ 18 years of age on day of signing informed consent.\n3. Participant with histologically or cytologically confirmed diagnosis of advanced unresectable and\u002For metastatic solid tumors\n4. A male participant must agree to use contraception and refrain from sperm donation or expecting to father a child\n5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential\n6. Have measurable disease per RECIST 1.1 as assessed by the local site investigator\u002Fradiology\n7. Able to provide tumor tissue sample.\n8. Willing to undergo fresh tumor biopsy at Screening and On-treatment if archival tissue not available\n9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n10. Life expectancy greater than or equal to 12 weeks as judged by the Investigator.\n11. Have adequate organ function\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive serum pregnancy test (within 72 hours) prior to treatment.\n2. Has received prior investigational agents within 4 weeks prior to treatment.\n3. Has received anti-cancer chemotherapy (Immunotherapy (non-antibody-based therapy), retinoid therapy, hormonal therapy within 2 weeks prior to treatment.\n4. Has received antibody-based anti-cancer therapy within 4 weeks prior to treatment.\n5. Has received targeted agents and small molecules within 2 weeks or 5 half-lives, whichever is longer.\n6. Has received prior platinum-based chemotherapy and progressed within 4 weeks of initiating therapy (platinum-refractory disease)\n7. Has received an ADC with MMAE payload.\n8. Has received prior radiotherapy within 2 weeks of start of study treatment for focal radiation or within 4 weeks for wide-field radiotherapy\n9. Has received G-CSF or GM-CSF within 7 days prior to start of study treatment.\n10. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.\n11. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n12. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n13. Has known active CNS metastases and\u002For carcinomatous meningitis\n14. Has severe hypersensitivity (≥ Grade 3), known allergy or reaction LNCB74 or any of its excipients.\n15. Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease.\n16. Has active ≥Grade 2 sensory or motor neuropathy.\n17. Has active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy or any clinically significant corneal disease.\n18. Has an active infection requiring systemic therapy.\n19. Any major surgery within 4 weeks of study drug administration.\n20. Toxicity (except for alopecia) related to prior anti-cancer therapy and\u002For surgery, unless the toxicity is either resolved, returned to baseline or Grade 1, or deemed irreversible.\n21. Prior organ or tissue allograft.\n22. Uncontrolled or significant cardiovascular disease\n23. Participants with serious or uncontrolled medical disorders.\n24. Participants who are on total parenteral nutrition (TPN)\n25. Participants with history of bowel obstruction within one month of screening\n26. Participants with history of significant ascites requiring paracentesis within 2 weeks of screening\n27. Has a known history of human immunodeficiency virus (HIV) infection with an acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within the last year, or a current CD4 count \\\u003C350 cells\u002Fµl\n28. Has known active Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection\n29. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study\n30. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study",{"count":185,"type":22},145,[56],"This is an open-label, phase 1, dose escalation and dose expansion study to determine safety and tolerability, and to determine the maximum tolerated dose and \u002F or recommended phase 2 dose of LNCB74 in participants with advanced solid tumors.",[29,136,61,189,190,191],"Biliary Tract Cancer","Non-Small Cell Lung Cancer","Advanced or Metastatic Solid Tumors",{"date":33,"type":34},{"date":194,"type":34},"2025-01-07",{"date":196,"type":22},"2026-12",{"name":198,"class":41},"NextCure, Inc.",14,{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":220},"100488130","phase-1-phase-1b-of-lurbinectedin-in-combination-with-weekly-paclitaxel-and-bevacizumab-in-platinum-resistant-ovarian-cancer-100488130","NCT05636111","Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer","Inclusion Criteria:\n\nInclusion criteria will be assessed within 28 days of starting study treatment:\n\n1. Ability to provide signed informed consent in accordance with federal, local, and institutional guidelines.\n2. Age ≥ 18 years at time of study entry\n3. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n4. Histologically confirmed and documented ovarian, fallopian tube or peritoneal carcinoma: Patients with platinum refractory\\* or platinum resistant\\*\\* disease are allowed. Prior anti-VEGF targeted therapy (e.g. bevacizumab, VEGF TKI's) is allowed.\n\n   * Platinum refractory is defined as progression during platinum-containing therapy or within 4 weeks of last dose.\n   * Platinum resistant is defined as relapse-free interval 1-6 months of a platinum-containing therapy\n5. Prior Therapy: Unlimited prior systemic therapies are allowed.\n6. ECOG performance status of 0-1 (Appendix A)\n7. Adequate normal organ and marrow function as defined below.\n\n   1. Hemoglobin ≥9.0 g\u002FdL.\n   2. Absolute neutrophil count (ANC) \\> 1500\u002Fmm3.\n   3. Platelet count ≥100 x 109\u002FL\n   4. Serum bilirubin ≤1.5 x ULN. This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\n   5. AST (SGOT)\u002FALT (SGPT) ≤2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN.\n   6. Measured creatinine clearance (CL) \\>40 mL\u002Fmin or Calculated creatinine CL\\>40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:\n\n   Creatinine CL (mL\u002Fmin) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg\u002FdL)\n8. Evidence of post-menopausal status or negative urine or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n   1. Women \\\u003C50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n   2. Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. For both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose.\n   3. Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n9. Measurable disease by RECIST v1.1\n\nExclusion Criteria:\n\nExclusion criteria will be assessed within 28 days of starting study treatment. Patients meeting any of the following exclusion criteria are not eligible to enroll in this study.\n\n1. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤2 weeks prior to cycle 1 day 1.\n2. Use of an anti-cancer treatment drug or investigational drug during the last 28 days or 5 half-lives (whichever is shorter) prior to cycle 1 day 1. A minimum of 10 days between termination of prior treatment and administration of study treatment is required.\n3. Patients with known or suspected conditions likely to increase gastrointestinal toxicity, such as inflammatory bowel disease, bowel obstruction, history of bowel obstruction, or overt bowel involvement by tumor.\n4. Patients who are pregnant or lactating.\n5. Major surgery \\\u003C\u002F= 28 days prior to cycle 1 day 1.\n6. Unstable cardiovascular function:\n\n   1. ECG abnormalities requiring treatment, or\n   2. congestive heart failure (CHF) of NYHA Class ≥3, or\n   3. myocardial infarction (MI) within 3 months.\n7. Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study.\n8. Any known history or evidence of hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen); Known to be HIV seropositive\n9. Grade \\>2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1).\n10. Serious psychiatric or medical conditions that could interfere with treatment;\n11. Participation in an investigational anti-cancer study within 3 weeks prior to Cycle 1 Day 1\n12. Concurrent therapy with approved or investigational anticancer therapeutic other than steroids.\n13. Patients with coagulation problems and active bleeding within 4 weeks prior to C1D1 (peptic ulcer, epistaxis, spontaneous bleeding)\n14. Patients with symptomatic brain lesions\n15. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).\n16. History of hemoptysis (1\u002F2 teaspoon of bright red blood per episode) within 1 month of study enrollment for any tumor type.\n17. Non-healing wound, ulcer or bone fracture.\n18. Known hypersensitivity to lurbinectedin, paclitaxel, bevacizumab or excipients.",{"count":207,"type":22},34,[56],"To learn if adding lurbinectedin to the combination of paclitaxel and bevacizumab can help to control advanced cancer.",[29],"2026-08-18",{"date":31,"type":34},{"date":214,"type":34},"2023-07-12",{"date":216,"type":22},"2026-12-31",{"name":218,"class":219},"M.D. Anderson Cancer Center","OTHER",1,{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":23,"phases":230,"briefSummary":231,"conditions":232,"keywords":235,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":240,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":247},"100407815","phase-1-a-study-to-find-out-how-safe-regn5668-is-and-how-well-it-works-in-adult-women-when-given-with-either-cemiplimab-or-cemiplimab--fianlimab-or-ubamatamab-100407815","NCT04590326","A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab","A Phase 1\u002F2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific Antibody) Administered in Combination With Other Agents in MUC16 + Malignancies","Key Inclusion Criteria:\n\n1. Ovarian Cancer Cohorts Only: Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy as defined in the protocol\n2. Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as described in the protocol.\n3. Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial cohorts)\n4. Has adequate organ and bone marrow function as defined in the protocol\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Has a life expectancy of at least 3 months\n7. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-PD-1 therapy and platinum-based chemotherapy as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Current or recent (as defined in the protocol) treatment with an investigational agent, systemic biologic therapy, or anti-cancer immunotherapy\n2. Has had another malignancy within the last 5 years that is progressing, requires active treatment, or has a high likelihood of recurrence as defined in the protocol\n3. Prior treatment with a Mucin 16 (MUC16)-targeted therapy\n4. Ovarian Expansion cohorts only: More than 5 prior lines of systemic therapy\n5. Has any condition that requires ongoing\u002Fcontinuous corticosteroid therapy as defined in the protocol within 1 week prior to the first dose of study drug\n6. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol\n7. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol\n8. Has history of clinically significant cardiovascular disease as defined in the protocol\n9. Has known allergy or hypersensitivity to cemiplimab and\u002For components of study drug(s).\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria apply",{"count":229,"type":22},612,[56,57],"This study is researching an investigational drug called REGN5668 :\n\n* alone or,\n* combined with cemiplimab (also known as REGN2810) or,\n* combined with both cemiplimab and fianlimab (also known as REGN3767), or\n* combined with ubamatamab (also known as REGN4018), with or without sarilumab.\n\nThe main purposes of this study are to:\n\n* Learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to participants with ovarian cancer or cancer of the uterus\n* Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus\n\nThis study has 2 parts. The purpose of Part 1 (Escalation) is to find the highest, safe dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1. Participants with cancer of the uterus will only participate in Part 2.\n\nThe study is looking at several other research questions, including:\n\n* Side effects that may be experienced by participants taking REGN5668 alone and\u002For in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab\n* How REGN5668 works in the body either alone and\u002For in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab\n* How much of the study drugs (REGN5668, cemiplimab, fianlimab, ubamatamab) are in the blood\n* To see if REGN5668 in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab works to treat cancer",[29,233,234,61],"Fallopian Tube Cancer","Primary Peritoneal Cancer",[236,237,238,239],"Progressive","Recurrent","Refractory","Serum CA-125 levels >= 2x ULN",{"date":31,"type":34},{"date":242,"type":34},"2020-12-08",{"date":244,"type":22},"2027-11-30",{"name":246,"class":41},"Regeneron Pharmaceuticals",28,{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":23,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":4},"100652734","phase-3-a-study-of-raludotatug-deruxtecan-with-or-without-bevacizumab-as-first-line-maintenance-treatment-in-non-hrd-positive-advanced-ovarian-cancer-mk-5909-006-engot-ov102gog-3141-rejoice-ovarian-04-100652734","NCT07776691","A Study of Raludotatug Deruxtecan With or Without Bevacizumab as First-Line Maintenance Treatment in Non-HRD-Positive Advanced Ovarian Cancer (MK-5909-006, (ENGOT-ov102\u002FGOG-3141\u002F REJOICE-Ovarian 04)","A Phase 3, Randomized, Open-label Study of Raludotatug Deruxtecan (MK-5909, R-DXd) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly-Diagnosed Advanced Non-HRD-Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (ENGOT-ov102\u002FMITO\u002FGOG-3141\u002F REJOICE-Ovarian 04)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a new, histologically confirmed diagnosis of International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV epithelial ovarian cancer (EOC) (high grade serous or high grade endometrioid), fallopian tube cancer, or primary peritoneal cancer\n* Has undergone primary debulking surgery (PDS) or interval debulking surgery (IDS)\n* Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol\n* Has provided tumor tissue that is not previously irradiated\n* Who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except alopecia or vitiligo), as assessed by the physician investigator\n* Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has non-serous or non-endometrioid high-grade epithelial histology, nonepithelial ovarian cancers, borderline tumors, mucinous tumor, seromucinous tumor that is predominately mucinous, malignant Brenner's tumor, and undifferentiated carcinoma\n* Has received 1L platinum-based chemotherapy without bevacizumab and have a response of SD or PR at the time of screening\n* Has received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria\n* Has not recovered from major surgery or has ongoing surgical complications\n* Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder or prior pneumonectomy\n* Has current, clinically relevant bowel obstruction including obstruction related to underlying EOC, abdominal fistula or gastrointestinal perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For multicentric Castleman disease\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has active infection requiring systemic therapy",{"count":256,"type":22},802,[25],"Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include:\n\nMaintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread.\n\nObservation, which is watching to see if cancer grows or worsens. The study medicine, raludotatug deruxtecan- R-DXd, is a targeted therapy. The goal of this study is to learn if people who receive R-DXd maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.",[29,28,260,233],"Peritoneal Cancer","2026-08-17",{"date":31,"type":34},{"date":264,"type":22},"2026-09-22",{"date":266,"type":22},"2034-10-22",{"name":40,"class":41},{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":275,"enrollmentInfo":276,"targetDuration":4,"studyType":23,"phases":278,"briefSummary":279,"conditions":280,"keywords":282,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":290,"locationsCount":220},"100652607","phase-2-trastuzumab-rezetecan-and-carboplatin--bevacizumab-versus-investigators-choice-chemotherapy-in-patients-with-platinum-sensitive-recurrent-ovarian-cancer-100652607","NCT07776171","Trastuzumab Rezetecan and Carboplatin ± Bevacizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-sensitive Recurrent Ovarian Cancer","Trastuzumab Rezetecan and Carboplatin With or Without Bevacizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-sensitive Recurrent Ovarian Cancer: an Open-label, Multicenter, Randomized Controlled Phase II Study","Inclusion Criteria:\n\n1. Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance.\n2. Aged 18 to 75 years.\n3. Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.\n4. Have received 1-3 prior lines of platinum-based chemotherapy and have experienced disease progression or recurrence ≥6 months after the last platinum-based treatment (platinum-sensitive relapse).\n5. Must have received prior treatment with a PARP inhibitor.\n6. Able to provide sufficient fresh or archival tumor tissue specimens for detection of HER2 expression levels.\n7. Have at least one measurable lesion per RECIST v1.1.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n9. Expected survival of more than 3 months.\n10. Adequate major organ function.\n11. Subjects of childbearing potential must use at least one medically approved contraceptive measure (e.g., intrauterine device, contraceptive pill, or condom) during the study treatment period and for 180 days after the end of study treatment; must have a negative serum\u002Furine HCG test before the first dose; and must not be breastfeeding.\n\nExclusion Criteria:\n\n1. Ovarian cancer with pathological types of clear cell carcinoma, low-grade serous adenocarcinoma, or mucinous adenocarcinoma.\n2. Known allergy to any component of trastuzumab rezetecan; known allergy to carboplatin.\n3. Prior treatment with anti-HER2 therapy, an antibody-drug conjugate (ADC) containing a topoisomerase I inhibitor, or a topoisomerase I inhibitor alone.\n4. Untreated or active central nervous system (CNS) metastases.\n5. Prior history of interstitial pneumonia\u002Finterstitial lung disease or non-infectious pneumonitis (e.g., radiation pneumonitis) that required steroid treatment; current or suspected interstitial pneumonia\u002Finterstitial lung disease, non-infectious pneumonitis, or other active pneumonitis.\n6. Active ulcer, intestinal perforation, or intestinal obstruction.\n7. Known hereditary or acquired bleeding disorders (e.g., coagulation dysfunction, hemophilia) or thrombotic tendency.\n8. Toxicity from prior anti-tumor therapy that has not recovered to ≤ Grade 1 per NCI-CTCAE v6.0.\n9. Arterial\u002Fvenous thrombotic events (including but not limited to cerebrovascular accident, deep vein thrombosis, and pulmonary embolism) within 6 months before the first dose; however, if muscular venous thrombosis or catheter-related thrombosis associated with an infusion port is present before the first dose and the investigator deems it to be without risk, the subject may be enrolled.\n10. Hypertension not well controlled with antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg).\n11. Uncontrolled or severe cardiovascular disease, such as unstable angina, symptomatic congestive heart failure (NYHA class II-IV), myocardial infarction within 6 months before the first dose, or unstable angina or unstable arrhythmia within 1 month before the first dose.\n12. Prior surgery, radical radiotherapy, chemotherapy, macromolecular targeted therapy, or anti-tumor immunotherapy with completion (last dose) less than 4 weeks before the first dose; prior small-molecule targeted drugs with last dose less than 5 half-lives or 4 weeks (whichever is shorter) before the first dose; prior palliative radiotherapy or local therapy with completion less than 2 weeks before the first dose.\n13. Pleural effusion, pericardial effusion, or ascites that cannot be controlled with appropriate interventions.\n14. Severe infection within 1 month before the first dose, including but not limited to infectious complications requiring hospitalization, bacteremia, or severe pneumonia.\n15. Concurrent or previous other malignancies, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and other malignancies that have been adequately treated and cured for ≥3 years with documented evidence of no recurrence or metastasis.\n16. History of immunodeficiency (including HIV-positive test), other acquired or congenital immunodeficiency diseases, or history of organ transplantation; known active hepatitis B (defined as HBsAg-positive with HBV DNA ≥500 IU\u002FmL \\[or ≥2500 copies\u002FmL if the study site only uses copies\u002FmL, in which case the subject is not eligible\\]) or active hepatitis C (defined as positive hepatitis C virus antibody \\[HCV-Ab\\] and positive HCV-RNA at screening).\n17. Any clinical or laboratory abnormality or other reason that, in the investigator's opinion, makes the subject unsuitable for participation in this clinical study.","75 Years",{"count":277,"type":22},176,[57],"This study is a randomized, open-label, controlled phase II clinical trial.\n\nIt is planned to enroll 176 subjects with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer previously treated with Poly (ADP-ribose) polymerase inhibitors (PARPi).\n\nSubjects will be randomly assigned in a 1:1 ratio to receive either the experimental treatment group (trastuzumab Rezetecan + carboplatin ± bevacizumab) or the control treatment group (investigator's choice chemotherapy ± bevacizumab).",[29,281],"Platinum Sensitive Ovarian Cancer (PSOC)",[283,284,285],"Ovarian cancer","Epithelial Ovarian Cancer","Platinum-sensitive recurrent ovarian cancer",{"date":31,"type":34},{"date":288,"type":22},"2026-09-30",{"date":102,"type":22},{"name":291,"class":219},"Sun Yat-sen University",{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":300,"briefSummary":301,"conditions":302,"keywords":310,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":152},"100606945","phase-1-a-phase-1-study-of-nrm-823-in-participants-with-locally-advanced-or-metastatic-refractory-solid-tumors-100606945","NCT07182149","A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors","A Phase 1a\u002F1b Study of NRM-823 as Monotherapy and in Combination With Immune Checkpoint Inhibition in Participants With Locally Advanced or Metastatic Refractory Solid Tumors","Inclusion Criteria:\n\n* Have histologically- or cytologically-diagnosed NSCLC (squamous or adenocarcinoma), TNBC, HNSCC, ESCC, esophageal adenocarcinoma, gastric\u002FGEJ adenocarcinoma, cervical, endometrial, or ovarian cancer which is advanced or metastatic.\n* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Adequate liver, renal, pulmonary, and cardiac function.\n* Adequate hematologic function.\n\nExclusion Criteria:\n\n* Has received cytotoxic chemotherapy, biologic anticancer agents, checkpoint inhibitors, or radiation therapy (excluding bone-only radiation therapy) ≤3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of NRM-823\n* History of Grade 2 pneumonitis requiring steroids or any Grade 3 or 4 pneumonitis from any prior therapy.\n* Has received an investigational therapy \\\u003C4 weeks or 5 half-lives prior to the first dose of NRM823, whichever is shorter prior to the first dose of NRM-823.\n* With the exception of alopecia and Grade ≤2 neuropathy, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study drug.",{"count":114,"type":22},[56],"This study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors.",[303,304,305,306,307,29,308,140,61,309],"HNSCC","ESCC","Esophageal Adenocarcinoma","Gastric Adenocarcinoma","GEJ Adenocarcinoma","NSCLC","Triple Negative Breast Cancer (TNBC)",[311],"NRM-823",{"date":211,"type":34},{"date":314,"type":34},"2025-10-30",{"date":316,"type":22},"2028-10-31",{"name":318,"class":41},"Normunity AccelCo, Inc.",{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":23,"phases":328,"briefSummary":329,"conditions":330,"keywords":334,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":349},"100577497","phase-1-first-in-human-study-of-atx-295-an-oral-inhibitor-of-kif18a-in-patients-with-advanced-or-metastatic-solid-tumors-including-ovarian-cancer-100577497","NCT06799065","First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer","A Phase 1\u002F2, Open-Label, Dose-Escalation and Expansion First-In-Human Study of ATX-295, an Oral Inhibitor of the Kinesin Motor Protein KIF18A, in Patients With Locally Advanced or Metastatic Solid Tumors, Including High-Grade Serous Ovarian Cancer","Key Inclusion Criteria:\n\n* Patients with histologically confirmed solid tumors who have locally recurrent or metastatic disease, including HGSOC\n* Refractory to or relapsed after all standard therapies with proven clinical benefit, unless as deemed by the Investigator, the subject is not a candidate for standard treatment, there is no standard treatment, or the subject refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit\n* For the expansion cohorts, participants must have histological confirmation of HGSOC and be determined to be platinum-resistant, platinum-refractory, or platinum-intolerant\n* There is no limit to the number of prior treatment regimens\n* Have measurable or evaluable disease\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n\nKey Exclusion Criteria:\n\n* Clinically unstable central nervous system (CNS) tumors or brain metastasis\n* Any other concurrent anti-cancer treatment, except for hormonal blockade\n* Has undergone a major surgery within 3 weeks of starting study treatment\n* Medical issue that limits oral ingestion or impairment of gastrointestinal function that is expected to significantly reduce the absorption of ATX-295, however participants with a functioning distal ileostomy or colostomy may be permitted on trial\n* Clinically significant (ie, active) or uncontrolled cardiovascular disease\n* Need to use proton pump inhibitors on study or H2-receptor antagonists for the dose escalation portion of the study.\n* Unable to transition off strong or moderate CYP3A4 inhibitors or strong inducers\n* Pregnancy or intent to breastfeed or conceive a child within the projected duration of treatment\n\nOther inclusion and exclusion criteria as defined in the study protocol",{"count":327,"type":22},90,[56],"The goal of this study is to identify a safe and tolerated dose of the orally administered KIF18A inhibitor ATX-295. In addition, this study will evaluate the pharmacokinetics, pharmacodynamics and preliminary antitumor activity of ATX-295 in patients with advanced solid tumors and ovarian cancer.",[143,331,29,332,333],"Breast Cancer Recurrent","High-grade Serous Ovarian Carcinoma","Triple Negative Breast Cancer",[335,336,337,338,339,340],"KIF","KIF18A","HGSOC","Platinum-resistant","Platinum-intolerant","Platinum-refractory","2026-08-15",{"date":211,"type":34},{"date":344,"type":34},"2025-03-21",{"date":346,"type":22},"2027-08-30",{"name":348,"class":41},"Accent Therapeutics",9,{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":357,"enrollmentInfo":358,"targetDuration":4,"studyType":23,"phases":360,"briefSummary":361,"conditions":362,"keywords":367,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":220},"100317456","phase-2-administration-of-autologous-t-cells-genetically-engineered-to-express-t-cell-receptors-reactive-against-neoantigens-in-people-with-metastatic-cancer-100317456","NCT03412877","Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer","A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in Patients With Metastatic Cancer","* INCLUSION CRITERIA:\n* Metastatic, solid cancer that can be measured, and falls into one of five cohorts: (1) gastrointestinal and genitourinary cancers; (2) breast, ovarian, and other solid cancers; (3) non-small cell lung cancer (NSCLC); (4) endocrine tumors including neuroendocrine tumors; and, (5) multiple myeloma that includes measurable solid tumors (plasmacytomas). Participants with multiple myeloma are potentially eligible only if they have measurable multiple myeloma as defined in Section 16.7 after plasmacytoma resection.\n\nNote: NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinomas.\n\n* Documented diagnosis of cancer.\n* Refractory to approved standard systemic therapy. Specifically:\n\n  * Participants with metastatic colorectal cancer must have received oxaliplatin or irinotecan.\n  * Participants with breast and ovarian cancer must be refractory to first- line treatment and refractory to or have refused second-line treatments.\n  * Participants with NSCLC must have received at least one platinum-based chemotherapy regimen and at least one FDA-approved targeted treatment (when appropriate).\n* Participants with endocrine tumors including neuroendocrine tumors must be refractory to first-line therapy (e.g., lanreotide, octreotide) and must be refractory or have refused second-line treatments such as everolimus, sunitinib, or 177 Lu-Dotatate, if indicated.\n* Participants with multiple myeloma must have received at least four prior lines of therapy that included at least one exposure to an immunomodulatory drug such as lenalidomide, a proteosome inhibitor, an anti-CD38 antibody treatment, and an autologous stem cell transplant.\n* Participants with three (3) or fewer brain metastases that are \\\u003C 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month after treatment for the participant to be eligible. Participants with surgically resected brain metastases are eligible.\n* Age greater than or equal to 18 years and less than or equal to 72 years.\n* Clinical performance status of ECOG 0 or 1.\n* Participants of both sexes must be willing to practice birth control from the time of enrollment on this study and for and 12 months after the last dose of combined chemotherapy for individuals of child-bearing potential (IOCBP) and four months after treatment for participants who can father a child.\n* Individuals of child-bearing potential must be willing to undergo a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.\n\nNOTE: Certain malignancies may secrete hormones that produce false positive pregnancy tests. Serial blood testing (e.g. HCG measurements) and\u002F or ultrasound may be performed for clarification.\n\n* Serology:\n\n  * Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who are HIV seropositive may have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)\n  * Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then participant must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n* Hematology:\n\n  * ANC \\> 1000\u002Fmm\\^3 without the support of filgrastim\n  * WBC greater than or equal to 2500\u002Fmm\\^3\n  * Platelet count greater than or equal to 80,000\u002Fmm\\^3\n  * Hemoglobin \\> 8.0 g\u002FdL. Subjects may be transfused to reach this cut-off.\n* Chemistry:\n\n  * Serum ALT\u002FAST less than or equal to 5.0 x ULN\n  * Serum creatinine less than or equal to 1.6 mg\u002FdL.\n  * Total bilirubin less than or equal to 2.0 mg\u002FdL, except in participants with Gilbert's Syndrome, who must have a total bilirubin less than or equal to 3.0 mg\u002FdL.\n* Participants must have completed any prior systemic therapy at the time of enrollment.\n\nNote: Participants may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to enrollment, as long as related major organ toxicities have recovered to grade 1 or less. In addition, participants with multiple myeloma may receive bridging therapy during the time between study enrollment and start of study therapy. This may be necessary due to the long time needed for cell production on this study. After bridging therapy and within 14 days of protocol treatment start, participants with multiple myeloma must still have measurable multiple myeloma.\n\n* For Cohort 3: More than two weeks must have elapsed since any prior palliation for major bronchial occlusion or bleeding at the time the patient receives the preparative regimen, and patient s toxicities must have recovered to a grade 1 or less.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Willing to sign a durable power of attorney.\n* Subjects must be co-enrolled on protocol 03-C-0277.\n\nEXCLUSION CRITERIA:\n\n* Participants who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant.\n* Concurrent systemic steroid therapy.\n* Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.\n* For Cohort 3: Any major bronchial occlusion or bleeding not amenable to palliation.\n* Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).\n* History of major organ autoimmune disease.\n* For Arm 2: Grade 3 or 4 major organ irAEs following treatment with anti-PD-1\u002FPD-L1, including but not limited to myocarditis and pneumonitis.\n\nNote: Participants with grade 3 or 4 major organ irAEs may be enrolled on Arm 1 if all other eligibility criteria are met.\n\n* Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n* History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.\n* For Cohorts 1, 2, 4. or 5: Clinically significant participant history which in the judgment of the Principal Investigator (PI) would compromise the participants ability to tolerate high-dose aldesleukin.\n\nNote: At the discretion of the PI, participants enrolled in Cohort 3 may receive low-dose aldesleukin.\n\n* History of coronary revascularization or ischemic symptoms.\n* For select participants with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.\n* For select participants with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50% predicted.\n* Participants who are receiving any other investigational agents.","72 Years",{"count":359,"type":22},285,[57],"Background:\n\nA person s tumor is studied for mutations. When cells are found that can attack the mutation in a person s tumor, the genes from those cells are studied to find the parts that make the attack possible. White blood cells are then taken from the person s body, and the gene transfer occurs in a laboratory. A type of virus is used to transfer the genes that make those white blood cells able to attack the mutation in the tumor. The gene transfer therapy is the return of those white blood cells back to the person.\n\nObjective:\n\nTo see if gene transfer therapy of white blood cells can shrink tumors.\n\nEligibility:\n\nPeople with certain metastatic cancer for which standard treatments have not worked.\n\nDesign:\n\nParticipants may complete screening under another protocol. Screening includes:\n\n* Getting tumor cells from a previous procedure\n* Medical history\n* Physical exam\n* Scans\n* Blood, urine, heart, and lung tests\n\nThe study has 8 stages:\n\n1. Screening tests repeated over 1-2 weeks. Participants will have leukapheresis: Blood is removed by a needle in one arm. A machine removes white blood cells. The rest of the blood is returned by a needle in the other arm.\n2. Care at home over approximately 12 weeks.\n3. Stopping therapy for 4-6 weeks while their cells are changed in a lab.\n4. Hospital stay approximately 3-4 weeks for treatment. An IV catheter will be placed in the chest to administer drugs.\n5. Patients on Arm 2 of the study will receive the first dose of pembrolizumab while in the hospital. Three additional doses will be given after the cell infusion 3 weeks apart.\n6. Receiving changed cells by catheter. Then getting a drug over 1-5 days to help the cells live longer.\n7. Recover in the hospital for 1-2 weeks. Participants will get drugs and have blood and urine tests.\n8. Participants will take an antibiotic and maybe an antiviral for at least 6 months after treatment. They will have repeat screening tests at visits every few months for the first year, every 6 months for the second year, then as determined.\n\n   ...",[363,190,29,136,364,365,366],"Endocrine Tumors","Gastrointestinal\u002FGenitourinary Cancers","Neuroendocrine Tumors","Multiple Myeloma",[368,369,370,371],"Gene Therapy","Immunotherapy","Cell Therapy","Adoptive Cell Therapy",{"date":211,"type":34},{"date":374,"type":34},"2018-09-06",{"date":376,"type":22},"2029-03-23",{"name":378,"class":379},"National Cancer Institute (NCI)","NIH",{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":51,"minAge":387,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":390,"phases":4,"briefSummary":391,"conditions":392,"keywords":396,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":4,"leadSponsor":407,"locationsCount":220},"100166536","collection-of-blood-from-patients-with-cancer-other-tumors-or-tumor-predisposition-syndromes-for-genetic-analysis-100166536","NCT01441089","Collection of Blood From Patients With Cancer, Other Tumors, or Tumor Predisposition Syndromes for Genetic Analysis","Collection of Blood From Therapeutic Trial Participants for Analysis of Genetic Differences in Drug Disposition and Pharmacokinetics of Probe Medications","* INCLUSION CRITERIA:\n* Any individual currently enrolled in an NIH intramural research program clinical trials receiving treatment.\n* Ability of participant or Legally Authorized Representative (LAR) to understand and be willing to sign the informed consent document.\n* Age \\>= 3 years old\n\nEXCLUSION CRITERIA:\n\n-N\u002FA","3 Years",{"count":389,"type":22},1100,"OBSERVATIONAL","Background:\n\n\\- Some genes may be associated with a greater chance of side effects during cancer treatment. These genes may also make certain treatments less effective. Researchers want to collect blood or cheek swab samples from people having cancer treatment to study these genes.\n\nObjectives:\n\n\\- To obtain a blood or cheek swab sample to study genetic differences that may affect cancer treatment.\n\nEligibility:\n\n\\- Individuals with cancer who are being treated at the National Cancer Institute.\n\nDesign:\n\n* Participants will provide a blood sample for study.\n* Participants who have blood-based cancer, such as leukemia, will provide a cheek swab sample.\n* If the blood or cheek swab sample does not have enough genetic material for analysis, an additional sample may be collected.",[393,136,394,29,395],"Prostate Cancer","Lung Cancer","Lymphoma",[397,398,399,400,401,402,403],"Pharmacogenetics","Pharmacokinetics","Pharmacodynamics","Clinical Outcome","Drug Metabolism and Transport","Natural History","Cancer",{"date":211,"type":34},{"date":406,"type":34},"2012-05-21",{"name":378,"class":379},{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":23,"phases":418,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":438},"100644197","phase-1-study-of-cryptivax-1001-in-maintenance-setting-for-advanced-serous-ovarian-fallopian-tube-or-primary-peritoneal-cancer-100644197","NCT07665515","Study of CryptiVax-1001 in Maintenance Setting for Advanced Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer","A Phase I\u002FIb, Multi-centre, Open-label Study to Evaluate the Safety, Tolerability, and Immunogenicity of CryptiVax-1001, a mRNA Lipid Nanoparticle Therapeutic Cancer Vaccine, in Participants With FIGO Stage III-IV High-Grade Serous or Predominantly Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Following Optimal Primary\u002FInterval Debulking Surgery and First-Line Platinum-Based Chemotherapy (OVACT Study)","OVACT","Inclusion Criteria:\n\n* Able to comprehend and are willing to sign the ICF and willing to follow the study procedures\n* Female, aged 18 years of age or older at the time of informed consent.\n* Histologically confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma of high-grade serous histology or other high-grade predominantly serous subtypes\n* The FIGO 2014 stage III or IV disease at initial diagnosis.\n* Underwent optimal PDS or IDS with residual disease ≤1 cm (R0 or R1 resection)\n* Completed first-line platinum-based chemotherapy (minimum 4 cycles of carboplatin and paclitaxel, or equivalent, received in either neoadjuvant or adjuvant, or both settings).\n* In the presence of measurable target lesion, achieved CR or PR per investigator assessment based on RECIST 1.1 after completion of chemotherapy. In the absence of measurable target lesion, no new lesion or overt progression per investigator assessment based on RECIST 1.1 after completion of chemotherapy.\n* A minimum of 4 weeks from screening since the last dose of first-line platinum-based chemotherapy but not more than 12 weeks from screening since the last dose of first-line platinum-based chemotherapy.\n* No evidence of radiologic or clinical progression between the end of chemotherapy and baseline screening.\n* Known BRCAwt status.\n* HRP confirmed\n* No prior, current, or planned treatment with bevacizumab or PARPi in the first-line maintenance setting.\n* ECOG performance status of 0 or 1.\n* Adequate haematologic and organ function\n* Negative pregnancy test for WOCBP.\n* HLA type matching Cryptivax-1001\n\nExclusion Criteria:\n\n* Non-epithelial or low malignant potential ovarian tumours\n* Presence of uncontrolled ascites or pleural effusion requiring drainage within 4 weeks of screening.\n* Concurrent malignancy or history of another malignancy within the past 3 years except for malignancies with a negligible risk of metastasis or death\n* Active autoimmune disease requiring systemic immunosuppression\n* Uncontrolled intercurrent illness that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments\n* History of anaphylactic reaction to mRNA-LNP therapies.\n* Previous treatment with any cancer vaccine, checkpoint inhibitor, or adoptive cellular immunotherapy.\n* Administration of any vaccine within 30 days prior to first dosing.\n* Participation in a clinical study involving administration of an IMP (new chemical entity) in the past 90 days or 5 half-lives of that drug (if known) prior to first dosing, whichever is longer.",{"count":417,"type":22},50,[56],"Ovarian, fallopian tube, or primary peritoneal cancer, collectively referred to as ovarian cancer, remains the deadliest type of gynaecological cancer. The most common and aggressive form is called high-grade serous ovarian cancer.\n\nThe main purpose of this study is to understand whether an experimental study vaccine, CryptiVax-1001, is safe when administered to patients with high-grade serous ovarian cancer (HGSOC). The study vaccine is a cancer vaccine, which aims to delay or possibly prevent the cancer from coming back. However, as this is the first study of the vaccine in patients, the primary purpose of this study is to assess the safety of the study vaccine.\n\nFollowing surgery and platinum-based chemotherapy participants may enter the trial and receive CryptiVax-1001 as an explorative maintenance therapy.\n\nThe main purposes of this study are therefore to:\n\n* assess how well the study vaccine is tolerated and identify any side effects.\n* analyse the study vaccine's capacity to activate your immune system\n\nThe study will test escalating dose levels of CryptiVax-1001 based on the safety evaluations to estimate appropriate future dose levels for CryptiVax-1001.",[29,337,421],"HGS Ovarian, Fallopian Tube or Primary Peritoneal Cancer",[423,424,425,426,427,428,429],"ovarian cancer","Maintenance","FIGO stage III-IV","HRP","BRCAwt","mRNA vaccine","CryptiVax-1001","2026-08-14",{"date":261,"type":34},{"date":433,"type":22},"2026-09",{"date":435,"type":22},"2029-04",{"name":437,"class":41},"Epitopea Ltd",10,{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":23,"phases":448,"briefSummary":450,"conditions":451,"keywords":453,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":464,"leadSponsor":466,"locationsCount":4},"100629019","phase-4-cytalux-dose-extension-study-100629019","NCT07469202","CYTALUX Dose Extension Study","Prospective, Multi Center, Open Label Non Inferiority Trial Evaluating the Clinical Adequacy of Intraoperative Tumor Fluorescence With Cytalux™ (Pafolacianine) Across Two Preoperative Administration Windows in Adults Undergoing Surgery for Suspected Lung Cancer or Confirmed Ovarian Cancer","Inclusion Criteria:\n\n1. Male and female patients 18 years of age and older\n2. Primary diagnosis, or a high clinical suspicion, of cancer in the lung warranting surgery based on CT\u002FPET or other imaging obtained within 4 months of the screening visit, or have a primary diagnosis for ovarian cancer\n3. Scheduled to undergo surgical thoracoscopy for wedge resection or anatomic lung resection, or ovarian cancer debulking\u002Fcytoreduction\n4. Willingness of research participant or legal guardian\u002Frepresentative to give written informed consent\n\nExclusion Criteria:\n\n1. History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation.\n2. History of allergy to any of the components of Cytalux™ (pafolacianine)\n3. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule\n4. Known sensitivity to fluorescent light\n5. Impaired renal function defined as eGFR\\\u003C 50 mL\u002Fmin\u002F1.73m2\n6. Impaired liver function defined as values \\> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \\>2x ULN for total bilirubin excluding those patients with Gilbert's syndrome\n7. Pregnant and\u002For lactating women\n8. Administration of folate, folic acid, or folate-containing supplements 48 hours before administration of Cytalux™ (pafolacianine)",{"count":447,"type":22},106,[449],"PHASE4","The goal of this clinical trial is to learn whether giving Cytalux™ (pafolacianine) injection several days before surgery works as well as giving it closer to the time of surgery for helping surgeons see lesions during an operation. This study is being done in adult patients undergoing surgery for malignant or non-malignant lung lesions or for confirmed ovarian cancer.",[452,29],"Cancer in the Lung",[454,455,423,456,457,458,459,460,461],"cancer in the lung","lung cancer","lung cancer surgery","ovarian cancer surgery","CYTALUX","pafolacianine","fluorescent","molecular imaging",{"date":211,"type":34},{"date":341,"type":22},{"date":465,"type":22},"2027-02-28",{"name":467,"class":41},"On Target Laboratories, LLC",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":475,"targetDuration":4,"studyType":23,"phases":477,"briefSummary":478,"conditions":479,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":487},"100579451","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-sacituzumab-tirumotecan-mk-2870-maintenance-treatment-versus-standard-of-care-in-participants-with-platinum-sensitive-recurrent-ovarian-cancer-mk-2870-022trofuse-022engot-ov84gog-3103-100579451","NCT06824467","A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022\u002FTroFuse-022\u002FENGOT-ov84\u002FGOG-3103)","A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022\u002FENGOT-ov84\u002FGOG-3103)","Inclusion Criteria:\n\n* Has locally advanced or metastatic, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies\n* Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 to 8 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC)\n* Has platinum-sensitive epithelial OC\n* Has provided tissue of a tumor lesion that was not previously irradiated\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy\n* Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2)\n* Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Has an ECOG performance status of 0 or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)\n\nExclusion Criteria:\n\n* Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), low-grade serous tumors, low-grade endometrioid tumors, borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma\n* Has platinum-resistant OC or platinum-refractory OC\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids, has current pneumonitis\u002FILD, or has suspected pneumonitis or ILD that cannot be ruled out by standard diagnostic assessments at Screening\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has received more than 2 prior lines of systemic therapy for OC\n* Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2)\n* Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids\n* Has an additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has an active infection requiring systemic therapy\n* Has active or ongoing stomatitis",{"count":476,"type":22},770,[25],"The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.",[29,233,234],"2026-08-13",{"date":430,"type":34},{"date":483,"type":34},"2025-04-09",{"date":485,"type":22},"2032-11-09",{"name":40,"class":41},191,{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":494,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":23,"phases":498,"briefSummary":499,"conditions":500,"keywords":502,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":505,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":512},"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","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",{"count":497,"type":22},250,[56,57],"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.",[29,501],"Non-small Cell Lung Cancer",[503,64,504],"TUB-040","PROC",{"date":261,"type":34},{"date":507,"type":34},"2024-06-12",{"date":509,"type":22},"2027-12",{"name":511,"class":41},"Tubulis GmbH",16,{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":52,"enrollmentInfo":520,"targetDuration":4,"studyType":23,"phases":522,"briefSummary":523,"conditions":524,"keywords":529,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":542},"100476843","phase-2-study-of-dato-dxd-as-monotherapy-and-in-combination-with-anti-cancer-agents-in-patients-with-advanced-solid-tumours-tropion-pantumor03-100476843","NCT05489211","Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)","A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced\u002FMetastatic Solid Tumours","Key Inclusion Criteria: There are additional substudy requirements not reflected here. This list is based solely on the master CSP\n\n* Male and female, ≥ 18 years\n* Documented advanced or metastatic malignancy\n* Eastern Cooperative Oncology Group performance status of 0 or 1 with no deterioration over the 2 weeks prior to baseline or day of first dosing\n* All participants must provide a tumour sample for tissue-based analysis\n* At least 1 measurable lesion not previously irradiated, except Substudy 3 (Prostate Cancer) which allows participants with non measurable bone metastatic disease\n* Adequate bone marrow reserve and organ function\n* Minimum life expectancy of 12 weeks\n* At the time of screening, contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n* All women of childbearing potential must have a negative serum pregnancy test documented during screening\n* Female participants must be 1 year post-menopausal, surgically sterile, or using 1 highly effective form of birth control. Female participants must not donate, or retrieve for their own use, ova at any time during this study\n* Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile, avoid intercourse, or use a highly effective method of contraception. Male participants must not freeze or donate sperm at any time during this study.\n* Capable of giving signed informed consent\n* Provision of signed and dated written optional genetic research informed consent prior to collection of samples for optional genetic research that supports the Genomic Initiative\n\nKey Exclusion Criteria:\n\n* Any evidence of diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol\n* History of another primary malignancy except for adequately resected basal cell carcinoma or in situ squamous cell carcinoma of the skin, or other solid malignancy treated with curative intent\n* Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved\n* Irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the investigator, for example hearing loss\n* Spinal cord compression or brain metastases unless treated\n* Leptomeningeal carcinomatosis\n* Clinically significant corneal disease\n* Active hepatitis or uncontrolled hepatitis B or C virus infection\n* Uncontrolled infection requiring IV antibiotics, antivirals or antifungals, for example prodromal symptoms\n* Known HIV infection that is not well controlled\n* Known active tuberculosis infection\n* Mean resting corrected QTcF \\> 470 ms\n* In the judgement of the investigator, history of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause TdP\n* In the judgement of the investigator, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives\n* Uncontrolled or significant cardiac diseases\n* History of non-infectious Interstitial lung disease (ILD)\u002Fpneumonitis, including radiation pneumonitis that required steroids\n* Has severe pulmonary function compromise\n* Prior exposure to chloroquine\u002Fhydroxychloroquine without an adequate treatment washout period\n* Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention\n* Prior exposure to anticancer therapies without an adequate treatment washout period prior to enrolment or any concurrent anticancer treatment\n* Palliative radiotherapy with a limited field of radiation within ≤ 2 weeks or to more than 30% of the bone marrow within ≤ 4 weeks before the first dose of study intervention\n* Major surgical procedure or significant traumatic injury within ≤ 3 weeks of the first dose of study intervention or an anticipated need for major surgery during the study\n* Prior treatment with TROP2-directed therapies or other antibody-drug conjugate (ADCs) with deruxtecan payload\n* Herbal or natural products intended as treatment or prophylaxis for any type of cancer that may interfere with the activity of the study intervention\n* Previous treatment in the present study\n* Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 4 weeks prior to first dose of study intervention or concurrent enrolment in another clinical study\n* Severe hypersensitivity to Dato-DXd or any of the excipients, including but not limited to polysorbate 80 or other monoclonal antibodies\n* Involvement in the planning and\u002For conduct of the study\n* Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements\n* Females that are pregnant, breastfeeding, or planning to become pregnant\n* Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of Dato-DXd",{"count":521,"type":22},454,[57],"TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced\u002FMetastatic Solid Tumours.",[61,525,526,29,527,528,189],"Gastric Cancer","Metastatic Castration-resistant Prostate Cancer","Colorectal Cancer","Urothelial Cancer",[530,531,532,533,534],"TROPION-PanTumor03","Datopotamab Deruxtecan (Dato-DXd)","Solid Tumours","Antibody-drug conjugate (ADC)","Trophoblast cell surface protein 2 (TROP2)","2026-08-12",{"date":480,"type":34},{"date":538,"type":34},"2022-09-06",{"date":540,"type":22},"2027-10-01",{"name":82,"class":41},96,{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":357,"enrollmentInfo":550,"targetDuration":4,"studyType":23,"phases":552,"briefSummary":553,"conditions":554,"keywords":558,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":220},"100272786","phase-1-administering-peripheral-blood-lymphocytes-transduced-with-a-cd70-binding-chimeric-antigen-receptor-to-people-with-cd70-expressing-cancers-100272786","NCT02830724","Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers","A Phase I\u002FII Study Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to Patients With CD70-Expressing Cancers","* INCLUSION CRITERIA:\n* For Phase I: Evaluable, unresectable cancer expressing CD70 as assessed by immunohistochemistry of resected tissue (greater than or equal to 2+ CD70 positive on greater than or equal to 50% of cancer cells, or greater than or equal to 1+ CD70 positive on greater than or equal to 75% of cancer cells).\n* For Phase II: Measurable (per RECIST v1.1 criteria), unresectable cancer expressing CD70 as assessed by immunohistochemistry of resected tissue (greater than or equal to 2+ CD70 positive on greater than or equal to 50% of cancer cells, or greater than or equal to 1+ CD70 positive on greater than or equal to 75% of cancer cells).\n* Confirmation of the diagnosis of cancer by the NCI Laboratory of Pathology.\n* Patients must have previously received at least one standard therapy for their cancer (if available) and have been either non-responders (progressive disease) or have recurred.\n* Patients with 3 or fewer brain metastases that are less than or equal to 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.\n* Age greater than or equal to 18 years and less than or equal to 72 years.\n* Clinical performance status of ECOG 0 or 1\n* Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and for 12 months after the last dose of combined chemotherapy for women and for four months after treatment for men.\n* Women of child-bearing potential must be willing to undergo a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.\n\nNOTE: Certain malignancies may secrete hormones that produce false positive pregnancy tests. Serial blood testing (e.g. HCG measurements) and\u002F or ultrasound may be performed for clarification.\n\n-Serology\n\n--Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive may have decreased immune-competence and thus be less responsive to the experimental\n\ntreatment and more susceptible to its toxicities.)\n\n* Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n\n  -Hematology\n* ANC greater than 1000\u002Fmm(3) without the support of filgrastim\n* WBC greater than or equal to 2500\u002Fmm(3)\n* Platelet count greater than or equal to 80,000\u002Fmm(3)\n* Hemoglobin \\> 8.0 g\u002FdL. Subjects may be transfused to reach this cut-off.\n\n  -Chemistry\n* Serum ALT\u002FAST less than or equal to 5.0 times ULN\n* Serum creatinine less than or equal to 1.6 mg\u002FdL\n* Total bilirubin less than or equal to 2.0 mg\u002FdL, except in patients with Gilbert s Syndrome who must have a total bilirubin less than 3.0 mg\u002FdL.\n\n  * Patients must have completed any prior systemic therapy at the time of enrollment.\n\nNote: Patients may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to enrollment, as long as related major organ toxicities have recovered to grade 1 or less.\n\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Willing to sign a durable power of attorney.\n* Subjects must be co-enrolled on the NCI-SB cell harvest protocol 03-C-0277 (Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols).\n\nEXCLUSION CRITERIA:\n\n* Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.\n* Concurrent systemic steroid therapy.\n* Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.\n* Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).\n* History of hematopoietic autoimmune disease or any autoimmune disease requiring immunosuppressive measures.\n* Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities).\n* History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.\n* History of coronary revascularization or ischemic symptoms.\n* For select patients with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.\n* For select patients with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50% predicted.\n* Patients who are receiving any other investigational agents.",{"count":551,"type":22},124,[56,57],"Background:\n\nIn a new cancer therapy, researchers take a person s blood, select a certain white blood cell to grow in the lab, and then change the genes of these cells using a virus. The cells are then given back to the person. This is called gene transfer. For this study, researchers will modify the person s white blood cells with anti-CD70.\n\nObjectives:\n\nTo see if a gene transfer with anti-CD70 cells can safely shrink tumors and to be certain the treatment is safe.\n\nEligibility:\n\nAdults age 18 and older diagnosed with cancer that has the CD70-expressing cancer.\n\nDesign:\n\nParticipants will be screened with medical history, physical exam, scans, and other tests. They may by admitted to the hospital. Leukapheresis will be performed. For this, blood is removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm.\n\nEligible participants will have an intravenous catheter placed in their upper chest. Over several days, they will get chemotherapy drugs and the anti-CD70 cells. They will recover in the hospital.\n\nParticipants will take an antibiotic for 6 months after treatment. They will repeat leukapheresis.\n\nParticipants will visit the clinic every 1-3 months for the first year after treatment, every 6 months for the second year, and then as determined by their physician. Follow-up visits will take 1-2 days. At each visit, participants will have lab tests, imaging studies, and a physical exam.\n\nThroughout the study, blood will be taken and participants will have many tests to determine the size and extent of their tumor and the treatment s impact.",[555,556,136,557,29],"Pancreatic Cancer","Renal Cell Cancer","Melanoma",[559,556,370,560,369],"Metastatic Solid Cancers","CAR T-Cells",{"date":480,"type":34},{"date":563,"type":34},"2017-04-06",{"date":565,"type":22},"2030-01-01",{"name":378,"class":379},{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":23,"phases":575,"briefSummary":576,"conditions":577,"keywords":578,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":591},"100640634","phase-1-phase-1-safety-and-tolerability-study-of-xmab541-and-xmab808-in-advanced-solid-tumors-100640634","NCT07593092","Phase 1, Safety and Tolerability Study of XmAb541 and XmAb808 in Advanced Solid Tumors","A Phase 1 Trial, Evaluating the Safety and Tolerability of XmAb541 in Combination With XmAb808 in Advanced Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* CLDN6+ tumor\n* Histological or cytological documentation of locally advanced, recurrent, or metastatic high grade serous ovarian carcinoma (HGSOC) including fallopian tube or primary peritoneal origin\n* Adequate Eastern Cooperative Oncology Group performance status\n* Life expectancy ≥ 3 months\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior exposure to a CLDN6 targeting immune cell engager\n* Patients with treated brain metastases may participate, provided they are radiologically stable.\n* Active known or suspected autoimmune disease\n* Have any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug\n* Clinically significant cardiovascular, pulmonary or gastrointestinal disease\n* Active viral hepatitis B or hepatitis C",{"count":327,"type":22},[56],"The primary purpose of this study is to determine whether the combination of the investigational drug XmAb541 in combination with the investigational drug XmAb808 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 in combination with XmAb808 on participants' tumor outcomes.",[29],[579,29,337,580,581,582],"Phase 1","B7H3","CLDN6","T-cell Engager","2026-08-11",{"date":480,"type":34},{"date":586,"type":34},"2026-06-30",{"date":588,"type":22},"2028-12",{"name":590,"class":41},"Xencor, Inc.",4,{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":4,"enrollmentInfo":599,"targetDuration":4,"studyType":23,"phases":601,"briefSummary":602,"conditions":603,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":611},"100596234","phase-1-a-phase-ib-clinical-trial-of-lbl-024-combined-with-paclitaxel-in-patients-with-platinum-resistant-ovarian-cancer-100596234","NCT07042802","A Study of LBL-024 in Combination With Paclitaxel ± Bevacizumab for the Treatment of Platinum-resistant Ovarian Cancer","An Open-label, Multi-center Phase Ib\u002FII Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Paclitaxel Injection ± Bevacizumab in Patients With Platinum-resistant Ovarian Cancer","Inclusion Criteria:\n\n1. Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.\n2. At the time of signing the informed consent form, the age was ≥ 18 years old.\n3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\\~1.\n4. The expected survival time is at least 12 weeks.\n5. According to the evaluation of RECIST 1.1 （Response Evaluation Criteria in Solid Tumours），the Participants enrolled have at least one measurable lesion.\n6. Females of childbearing age are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug;Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.\n\nExclusion Criteria:\n\n1. The Participants is currently participating in any other clinical trial,Or has received or is receiving other investigational agents within 4 weeks prior to the first dose of study drug.\n2. Use of immunomodulatory drugs within 2 weeks prior to the first use of study drug.\n3. Participants with active infection and currently requiring systemic treatment. active pulmonary tuberculosis (TB), receiving anti-tuberculosis treatment or Received anti-tuberculosis treatment within 6 months before screening.\n4. Participants with clinically uncontrollable pleural effusion, pericardial effusion or ascites, and those requiring repeated drainage or medical intervention.\n5. The Participants has a Medical history of immunodeficiency, including HIV antibody positive.\n6. Active hepatitis B or active hepatitis C.\n7. Women during pregnancy or lactation.\n8. History of mental and\u002For psychiatric illness (impairing understanding or giving informed consent), drug abuse, alcoholism, or drug addiction.\n9. The investigator believes that the Participants has other conditions that may affect compliance or are not suitable for participating in this study.",{"count":600,"type":22},180,[56,57],"This study is an open-label, multicenter Phase Ib\u002FII clinical trial of LBL-024 in combination with other drugs for the treatment of patients with platinum-resistant ovarian cancer (OC), aiming to evaluate the efficacy and safety of LBL-024 in combination with other drugs in the treatment of advanced recurrent platinum-resistant ovarian cancer (OC).",[29],{"date":480,"type":34},{"date":606,"type":34},"2025-12-02",{"date":608,"type":22},"2028-12-25",{"name":610,"class":41},"Nanjing Leads Biolabs Co.,Ltd",13,{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":4,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":51,"minAge":19,"maxAge":4,"enrollmentInfo":619,"targetDuration":4,"studyType":23,"phases":621,"briefSummary":622,"conditions":623,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":626,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":633},"100580714","phase-1-a-study-of-phst001-in-advanced-solid-tumors-100580714","NCT06840886","A Study of PHST001 in Advanced Solid Tumors","An Open-label, Phase 1a\u002F1b, Dose Escalation and Dose Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PHST001 in Adult Patients With Advanced Relapsed and\u002For Refractory Solid Tumors","Key Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced solid tumor which has relapsed from or been refractory to all locally available standard therapies.\n* Adequate organ function per laboratory testing\n* Pregnancy prevention requirements\n* Measurable disease per RECIST v1.1 (or RANO) as assessed by the local site Investigator\u002Fradiology\n* Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale\n\nKey Exclusion Criteria:\n\n* Diagnosis of immunodeficiency\n* History of a previous additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. Participants with basal cell carcinoma of the skin, Stage I melanoma, melanoma in situ, squamous cell carcinoma of the skin, early-stage prostate cancer, or carcinoma in situ, excluding carcinoma in situ of the bladder, who have undergone potentially curative therapy are not excluded and can be enrolled regardless of disease-free period following completion of potentially curative therapy. Participants with early-stage breast cancer who have undergone curative intent treatment and with no disease recurrence for 2 years after treatment are not excluded.\n* Active known CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated CNS metastases may participate provided they are radiologically stable (i.e., without evidence of progression for at least 2 weeks by repeat imaging \\[note that the repeat imaging should be performed during study screening\\]), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study treatment.\n* Received prior systemic anticancer therapy including investigational agents within 21 days or, if shorter, within 5 half-lives prior to the first dose of study treatment. Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.\n* Prior autologous or allogeneic hematopoietic stem cell transplant or solid organ transplant.\n* Received previous treatment with another agent targeting CD24.",{"count":620,"type":22},272,[56],"This is a multi-center, first-in-human (FIH), open-label, Phase 1a\u002F1b dose escalation and dose expansion study to assess the safety, PK, pharmacodynamics, and antitumor activity of PHST001 monotherapy (Phase 1a) or in combination with chemotherapy (Phase 1b) in adult participants with advanced relapsed and\u002For refractory solid tumors (including but not limited to CNS tumors in Phase 1a only). In Phase 1b cohort expansions, the study will focus on participants with advanced relapsed and\u002For refractory ovarian cancer, endometrial cancer, and cholangiocarcinoma. The study's primary objective is to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001 monotherapy and in combination with chemotherapy as well as assess the anti-tumor activity of PHST001 and chemotherapy in Phase 1b.",[143,29,61,624,625],"Cholangiocarcinoma","CNS Tumor",{"date":535,"type":34},{"date":628,"type":34},"2025-03-31",{"date":630,"type":22},"2031-04",{"name":632,"class":41},"Pheast Therapeutics",20,{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":4,"eligibilityCriteria":640,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":641,"targetDuration":4,"studyType":23,"phases":643,"briefSummary":644,"conditions":645,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":647,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":220},"100519240","phase-1-sacituzumab-govitecan-in-combination-with-cisplatin-in-platinum-sensitive-recurrent-ovarian-and-endometrial-cancer-100519240","NCT06040970","Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer","A Single-Center, Open-Label, Single-Arm, Phase I Study With Dose Expansion Cohort of Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer","Eligibility waivers are not permitted. Subjects must meet all of the inclusion and exclusion criteria to be registered to the study. Study treatment may not begin until a subject is registered.\n\nInclusion Criteria:\n\n* Pathologic (histology or cytology) confirmed diagnosis of epithelial ovarian cancer or endometrial cancer\n* Radiographic evidence of recurrent epithelial ovarian cancer (ovarian, fallopian tube, or primary peritoneal cancer) or endometrial cancer that is \"platinum-sensitive,\" defined as progression of disease beyond 6 months from the last dose of platinum-based chemotherapy\n* Female, age ≥ 18 years\n* World Health Organization (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks\n* Patient has measurable disease (at least one lesion that can be accurately assessed repeatedly by CT) as evidenced on pre-treatment baseline CT of Chest\u002FAbdomen\u002FPelvis or PET\u002FCT, or evaluable disease\n* Adequate hematologic counts, as defined below, without transfusion or growth factor support within 2 weeks of study drug initiation:\n\n  * Hemoglobin ≥ 8.5 g\u002FdL\n  * Absolute neutrophil count ≥ 1500\u002Fmm3\n  * Platelets ≥ 100,000\u002FμL\n* Adequate organ function as defined below:\n\n  * Total bilirubin ≤ 1.5 ULN\n  * AST(SGOT)\u002FALT(SPGT) ≤ 2.5x ULN or ≤ 5 x ULN if known liver metastases\n  * Serum albumin \\> 3 g\u002FdL\n  * Creatinine clearance ≥ 50 mL\u002Fmin per the Cockcroft-Gault equation\n* Women of childbearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\n  o A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n  * Has not undergone a hysterectomy or bilateral oophorectomy; or\n  * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n* Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\nTreatment with any of the following:\n\n* Any investigational agents or study drugs from a previous clinical study within 28 days or 5 half-lives (whichever is longer) of the first dose of study treatment\n* Any other chemotherapy, immunotherapy or anticancer agents within 14 days of the first dose of study treatment\n* Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment\n* Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment\n* With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment\n* As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or uncontrolled infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.\n* Known or severe (Grade 3 or higher) hypersensitivity to SG and\u002For cisplatin, their metabolites, or formulation excipients\n* Peripheral neuropathy grade 2 or greater\n* Refractory nausea and vomiting, chronic gastrointestinal diseases\n* Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.\n* Women of childbearing potential unwilling to use effective contraception during study until conclusion of 6-month post-treatment evaluation period\n* Known history of unstable angina, MI, or CHF present within 6 months of randomization or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy\n* Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months of enrollment.\n* Prior history of clinically significant bleeding, intestinal obstruction, or GI perforation within 6 months of enrollment.\n* Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.\n* Prior therapy with sacituzumab govitecan, irinotecan, Trop-2-directed antibody drug conjugate, or any topoisomerase I-containing antibody-drug conjugates at any time for early stage disease\n* Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment.\n* Requirement for ongoing therapy with any prohibited medications\n* Have known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable CNS disease for ≥ 4 weeks prior to randomization and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking 10 mg\u002Fday or less of prednisone or its equivalent. All participants with carcinomatous meningitis are excluded regardless of clinical stability.\n* Have an active second malignancy. Participants with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to randomization, or participants with surgically cured tumors with low risk of recurrence (e.g., nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll.\n* Use of any live vaccine against infectious diseases within 30 days of the first dose of study drugs.\n* Have an active serious infection requiring systemic antimicrobial therapy",{"count":642,"type":22},54,[56,57],"This is an open-label, Phase 1 study with a dose expansion cohort of Sacituzumab Govitecan in Combination with Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer. The goal of the study is to determine the optimal dose of sacituzumab govitecan for use in combination with cisplatin for treatment of epithelial ovarian and endometrial cancers.",[29,646],"Malignant Neoplasm of Uterus",{"date":480,"type":34},{"date":649,"type":34},"2024-10-28",{"date":651,"type":22},"2032-07-01",{"name":653,"class":219},"Icahn School of Medicine at Mount Sinai"]