[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"castration-resistant-prostate-cancer-crpc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:castration-resistant-prostate-cancer-crpc":166},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,55,87,118],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100650267","phase-2-study-of-oral-mrt-2359-with-apalutamide-in-prostate-cancer-100650267",false,"NCT07745361","Study of Oral MRT-2359 With Apalutamide in Prostate Cancer","MODeFIRe-1 (Molecular Degrader for Inhibitor Resistance): A Phase 2, Open-Label, Multicenter Study of Oral MRT-2359 in Combination With Apalutamide in Patients With Castration-Resistant Prostate Cancer","MODeFIRe-1","Inclusion Criteria:\n\n* Age \\> 18 years\n* A predicted life expectancy of ≥ 3 months and an ECOG performance status ≤ 1\n* Have histologically or cytologically confirmed castration-resistant adenocarcinoma of the prostate without small cell histology and with androgen receptor (AR) mutations\n* Have not had prior treatment with more than 1 prior taxane-based chemotherapy regimen for castration-resistant prostate cancer\n* Have no prior treatment with an AR degrader, opevesostat, or similar therapy\n* Has ongoing (chemical or surgical) androgen deprivation with serum testosterone \\\u003C 50 ng\u002FdL (\\\u003C 1.7 nM)\n* Has received prior treatment with poly(ADP-ribose) polymerase (PARP) inhibitor, if appropriate, or deemed ineligible to receive treatment by the Investigator, or has refused PARP inhibitor treatment\n* Has received prior treatment with at least 1 line of ARPi\n* Have disease measurable per Prostate Cancer Working Group 4 (PCWG4) criteria, with or without measurable disease by RECIST 1.1\n* Be able to provide a tumor biopsy for biomarker analysis during the Screening period\n* Have adequate organ function\n\nExclusion Criteria:\n\n* • Have received prior chemotherapy, definitive radiation, or biological cancer therapy within 21 days before the first dose of study treatment or have any AEs that have failed to recover to baseline\n\n  * Have received prior therapy with a GSPT1 degrader that was discontinued due to an AE\n  * Have received prior auto-HCT and have not fully recovered from effects of the last transplant\n  * Have received allogeneic hematopoietic stem cell transplantation within past 6 months and\u002For have symptoms of graft-versus-host disease\n  * Current use of chronic systemic steroid therapy in excess of replacement doses\n  * Have clinically active central nervous system involvement and\u002For carcinomatous meningitis\n  * Have a confirmed history of (noninfectious) pneumonitis that required steroids\n  * Clinically significant cardiac disease","MALE","18 Years",{"count":20,"type":21},25,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This Phase 2, open-label, multicenter study is conducted in patients with castration-resistant prostate cancer.\n\nPatients in this study receive MRT-2359, an investigational oral medicine, in combination with apalutamide, an oral medicine used to treat prostate cancer. The main purpose of the study is to assess whether this treatment combination can lower prostate-specific antigen (PSA) The study will also evaluate the safety and tolerability of the treatment combination and assess additional measures of anti-tumor activity.",[27,28,29,30],"Castration-Resistant Prostate Cancer (CRPC)","Castration-Resistant Prostate Cancer","Prostate Cancer","Prostate Cancer (Adenocarcinoma)",[32,33,34,35,36,37,38,39,40,41],"MRT-2359","apalutamide","castration-resistant prostate cancer","CRPC","androgen receptor mutation","AR mutation","PSA response","androgen receptor inhibitor","molecular glue degrader","GSPT1","RECRUITING","2026-08-03",{"date":45,"type":46},"2026-08-04","ACTUAL",{"date":48,"type":21},"2026-08",{"date":50,"type":21},"2028-04",{"name":52,"class":53},"Monte Rosa Therapeutics, Inc","INDUSTRY",14,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":67,"conditions":68,"keywords":69,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100646984","phase-1-safety-tolerability-and-efficacy-of-cp-pca07-in-combination-with-enzalutamide-in-patients-with-castration-resistant-prostate-cancer-100646984","NCT07683013","Safety, Tolerability, and Efficacy of CP-PCA07 in Combination With Enzalutamide in Patients With Castration-Resistant Prostate Cancer","An Open-Label, Dose-Escalation, Multicenter Phase 1 Study to Evaluate the Safety, Tolerability, and Efficacy of CP-PCA07 in Combination With Enzalutamide in Patients With Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n* 1\\. Male patients aged ≥19 years at the time of providing written informed consent.\n* 2\\. Patients with histologically or cytologically confirmed castration-resistant prostate cancer without small-cell features, who have experienced treatment failure with monotherapy of Enzalutamide or Abiraterone.\n* 3\\. Patients with a serum testosterone level \\\u003C 50 ng\u002FdL at screening.\n* 4\\. Patients with an increase in PSA compared to baseline, confirmed by two consecutive measurements within 8 weeks prior to the date of written informed consent (with at least 1 week between measurements and an increase of ≥ 50% compared to baseline).\n* 5\\. Patients with PSA levels ≥ 2 ng\u002FmL both prior to the date of written informed consent and at screening.\n* 6\\. Patients with an ECOG performance status ≤ 2 and an expected survival of at least 6 months.\n* 7\\. Patients whose spouse or partner is a woman of childbearing potential must agree to use one of the protocol-specified highly effective methods of contraception from the time of study participation consent until 3 months after the last administration of the investigational product.\n* 8\\. Patients who voluntarily agree to participate in this study and provide written informed consent.\n\nExclusion Criteria:\n\n* 1\\. Patients who have received chemotherapy, chemoradiotherapy, biologic therapy, immunotherapy, or radiotherapy within 4 weeks prior to the first administration of the investigational product (for docetaxel or cabazitaxel therapy, within 9 weeks prior to the screening date).\n* 2\\. Patients diagnosed with immunodeficiency or who are in an immune-suppressed condition.\n* 3\\. Patients with autoimmune diseases.\n* 4\\. Patients with a pacemaker or severe heart failure \\[Class III or IV heart failure according to the New York Heart Association (NYHA) classification\\], or patients with uncontrolled arrhythmia (all patients with implanted medical devices other than a pacemaker are excluded).\n* 5\\. Patients with a history of chronic liver disease or evidence of cirrhosis.\n* 6\\. Patients with a history of gastrectomy or other conditions that may affect drug absorption.\n* 7\\. Patients with a history of deep vein thrombosis, pulmonary embolism, acute coronary syndrome, or major cerebrovascular disease within 6 months prior to screening.\n* 8\\. Patients with a history of major surgery requiring general anesthesia or assisted ventilation within 4 weeks prior to screening.\n* 9\\. Patients with active hepatitis B, a history of hepatitis B, or known active hepatitis C virus infection at screening.\n* 10\\. Patients who meet any of the following laboratory criteria at screening:\n* ① Absolute neutrophil count (ANC) \\\u003C 1,500\u002FuL without G-CSF administration within 2 weeks prior to screening\n* ② Platelet \\\u003C 100,000\u002FuL without transfusion within 2 weeks prior to screening\n* ③ Hemoglobin \\\u003C 9.0 g\u002FdL without transfusion within 2 weeks prior to screening\n* ④ Serum creatinine \\> 1.8 mg\u002FdL or eGFR (or GFR) \\\u003C 40 mL\u002Fmin\u002F1.73 m2\n* ⑤ AST and ALT \\> 2.5 x ULN\n* ⑥ Total bilirubin \\> 2.0 x ULN\n* 11\\. Patients expected to have hypersensitivity to the active ingredient or components of the investigational product.\n* 12\\. Patients who have received another investigational drug or investigational medical device within 4 weeks prior to the first administration of the investigational product.\n* 13\\. Patients deemed by the investigator to be unsuitable for participation in the study or unable to comply with the study requirements due to other diseases or conditions.","19 Years",{"count":64,"type":21},18,[66],"PHASE1","The purpose of this clinical study is to evaluate the safety, tolerability, and efficacy of CP-PCA07 in combination with enzalutamide in patients with castration-resistant prostate cancer (CRPC).\n\nThis is an open-label, dose-escalation, multicenter Phase 1 study. The primary objective is to assess the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) to determine the recommended Phase 2 dose (RP2D) of the combination therapy.\n\nThe secondary objective is to assess changes in Prostate-Specific Antigen (PSA) levels and pharmacokinetic characteristics.\n\nExploratory objectives include assessment of tumor response, disease control, progression-free survival, and biomarker analyses, including AR-V7 status, according to RECIST version 1.1 and other applicable criteria.",[27],[70,35,71,72,73,74,75],"Castration-resistant prostate cancer","CP-PCA07","Enzalutamide","Niclosamide","Phase 1","Dose escalation","NOT_YET_RECRUITING","2026-07-02",{"date":79,"type":46},"2026-07-06",{"date":81,"type":21},"2026-07",{"date":83,"type":21},"2027-12",{"name":85,"class":53},"Hyundai Bioscience Co., Ltd.",1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":94,"minAge":18,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":105,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100634506","phase-1-a-study-to-investigate-the-safety-pharmacokinetics-and-preliminary-efficacy-of-ide574-therapy-in-adult-participants-with-advanced-solid-tumors-100634506","NCT07540572","A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors","An Open Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of IDE574 as Monotherapy in Locally Advanced or Metastatic Solid Tumors and as Combination Therapy With Fulvestrant in Locally Advanced or Metastatic ER+, HER2- Breast Cancer","Inclusion Criteria:\n\nArchival Tissue sample for testing\n\n* Part 1A - Participants with advanced or metastatic ER+, HER2- breast cancer, NSCLC, CRPC, and MSS colorectal adenocarcinoma who have progressed on\u002Fafter at least one line of standard of care therapy or are intolerant to additional effective therapies.\n* Parts 1B, 2A and 2B: Participants with ER+, HER2- breast cancer who have progressed after at least 1 prior line of treatment with an endocrine therapy and a CDK4\u002F6 inhibitor\n* Female participants with ER+, HER2- breast cancer considered to be of childbearing potential (or have tubal ligations only) must be willing to undergo medically induced menopause (Parts 2A and B only)\n* Female participants of nonchildbearing potential with ER+, HER2- breast cancer must meet at least 1 of the following criteria: Age ≥ 60 years or age \\\u003C60 years with absence of menstruation for at least 12 months, or had prior removal of both ovaries\n* Have Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤1.\n* Have adequate bone marrow, renal and liver function.\n* Life expectancy of \\>3 months\n* Able to safely administer and retain orally administered study treatment\n* Able to comply with contraceptive\u002Fbarrier requirements\n\nKey Exclusion Criteria:\n\n* Known symptomatic brain metastases or leptomeningeal metastasis\n* Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose with the exception of adequately treated localized tumor.\n* Have impairment of GI function or GI disease that may significantly alter the absorption of IDE574.\n* Have active liver or biliary disease.\n* Have active, uncontrolled bacterial, fungal, or viral infection\n* Have clinically significant cardiac abnormalities and\u002For blood clotting events within 6 months before the first dose\n* If participants had adverse reactions to previous experimental antitumor treatment that have not recovered to Grade ≤ 1\n* Prior irradiation to \\>25% of the bone marrow.\n* Known or suspected hypersensitivity to IDE574\u002Fexcipients or components (Parts 1 \\& 2) or fulvestrant\u002Fexcipients or components (Part 2 only)","ALL","99 Years",{"count":97,"type":21},160,[66],"IDE574 is a synthetically manufactured small molecule inhibitor that co-targets the lysine acetyltransferase enzymes KAT6 and KAT7.\n\nThe purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of IDE574 as monotherapy in participants with locally advanced or metastatic solid tumors and as combination therapy with fulvestrant in participants with advanced or metastatic ER+, HER2- breast cancer.",[101,102,103,104],"ER+, HER 2- Breast Cancer","Non-small Cell Lung Cancer (NSCLC)","Castration-resistant Prostate Cancer (CRPC)","Microsatellite Stable (MSS) Colorectal Carcinoma",[101,102,103,104,106,107],"KAT6A\u002FB","KAT7","2026-06-12",{"date":110,"type":46},"2026-06-16",{"date":112,"type":46},"2026-03-17",{"date":114,"type":21},"2030-06-30",{"name":116,"class":53},"IDEAYA Biosciences",11,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":94,"minAge":18,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":140,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":164,"locationsCount":5},"100607539","phase-1-177lu-betabart-in-patients-with-relapsedrefractory-locally-advanced-inoperable-or-metastatic-solid-tumors-100607539","NCT07189871","177Lu-BetaBart in Patients With Relapsed\u002FRefractory, Locally Advanced Inoperable, or Metastatic Solid Tumors","A Phase 1\u002F2a Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients With Relapsed\u002FRefractory, Locally Advanced Inoperable, or Metastatic Solid Tumors","BetaBart","Inclusion Criteria:\n\n1. Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n2. Participants ≥ 18 years of age.\n3. Participants with a documented history of histopathologically confirmed CRPC\\*, CRC, NSCLC, SCLC, HNSCC, ovarian cancer, cervical cancer, endometrial cancer, TNBC, or ESCC. (Note: inclusion or exclusion criteria below marked with \\* refer to CRPC only, criteria without \\* refer to all tumor indications including CRPC)\n\n   a. \\*Progressive CRPC defined as castrate levels of testosterone and progressing by at least one of the following criteria: i. Serum PSA progression consisting of two consecutive increases in PSA measured at least 1 week apart. The minimal baseline value is 2.0 ng\u002FmL.\n\n   ii. Soft tissue progression defined as a ≥20% increase in the sum of the diameter (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest sum of the diameter since the previous treatment was started or the appearance of one or more new lesions by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI).\n\n   iii. Progression of bone disease defined by Prostate Cancer Working Group 3 (PCWG3) as evaluable disease or new bone lesions by bone scan.\n\n   iv. Identification of new soft tissue or bone lesions on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging.\n\n   b. \\*Metastatic disease defined as either or both of the following: i. Documented M1 disease on conventional imaging (CT\u002FMRI of the chest\u002Fabdomen\u002Fpelvis and\u002For Technetium 99m \\[99mTc\\] whole-body bone scan) ii. Identification of bone lesion(s), extra-pelvic soft tissue lesion(s), or visceral metastases on PSMA PET imaging with an FDA-approved imaging agent (e.g., 68Ga-PSMA-11, 18F-DCFPyL, or 18F-rhPSMA-7.3) c. \\*Progression following treatment with ADT and at least one ARSI (e.g., enzalutamide, apalutamide, darolutamide, and\u002For abiraterone acetate). If a participant is currently on ADT, they should continue ADT for the duration of their participation in the study but will not be permitted to start a new therapy or ADT regimen. If a participant has progressed on an ARSI, they will have the option to remain on the same ARSI or discontinue therapy. If they discontinue the ARSI, a 28-day washout period will be required prior to initiating study intervention.\n\n   d. Prior definitive and palliative external beam radiation therapy and stereotactic body radiation therapy is allowed.\n\n   Note: Participants with extended external beam radiation therapy to the axial skeleton, which in the opinion of the Investigator may pose a risk for increased myelotoxicity, will be discussed with the Sponsor to determine eligibility.\n\n   e. Participants with liver metastases are eligible if they meet the following criteria: i. ≤3 lesions i. All lesions must be ≤2 cm in the short axis ii. SUVmean ≥2 x that of liver parenchyma f. \\*Prior treatment with one taxane-based chemotherapy is allowed but not required. A taxane-based chemotherapy is defined as a minimum exposure of two cycles of a taxane chemotherapy.\n4. Participants must have documented disease progression during or after their most recent line of anticancer therapy. Participants must be refractory to or intolerant of standard of care therapy or have no standard of care therapy available that is likely to provide clinical benefit. Any number of prior treatment lines are allowed.\n5. Must have at least 1 measurable target lesion according to RECIST v1.1. (Note: this does not apply for CRPC)\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n7. Participants must have a life expectancy of ≥ 4 months in the opinion of the Investigator.\n8. Participants of child-bearing potential (CBP) must have a negative β-hCG test and must not be breastfeeding. Participants of CBP are defined as those who are not surgically sterile or post-menopausal. Participants will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. Participants \\\u003C 50 years of age who meet the criteria for post-menopausal status without previous surgical sterilization should be considered for further investigation with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels to confirm serological post-menopausal status.\n9. Participants of CBP must agree to use a highly effective method of contraception during the study and for 6 months after the last dose of 177Lu-BetaBart, as described in Appendix 4.\n10. Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 6 months after the last dose of 177Lu-BetaBart, as described in Appendix 4. All male participants must agree to not donate sperm during the study and for 6 months after the last dose of 177Lu-BetaBart.\n11. Participants who have received prior radiation therapy \\>28 days before the first dose of 177Lu-BetaBart are permitted. Documentation of the dates the radiotherapy was received, the cumulative dose, and the absorbed dose to critical organs, if available, should be provided.\n12. Participants with previously treated brain metastases are eligible to participate if:\n\n    * they are neurologically and radiologically stable (no evidence of progression by imaging; same imaging modality \\[MRI or CT scan\\] must be used for each assessment) for at least 28 days prior to the first dose of 177Lu-BetaBart; and\n    * do not require corticosteroids to treat associated neurological symptoms or if required, are on a stable dose of corticosteroids not exceeding 10 mg\u002Fday of prednisone (or equivalent), and\n    * have no history of leptomeningeal disease or spinal cord compression.\n\nExclusion Criteria:\n\n1. History of prior organ transplant.\n2. Any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer. Participants with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with the Sponsor, if it is determined not to put the participant at an increased risk of adverse drug effects and\u002For interfere with the integrity of the study outcome.\n3. Have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures such as participants with severe claustrophobia who are unresponsive to oral anxiolytics, participants with low back pain who cannot lie comfortably on an imaging table, participants who are hyperactive or hyperkinetic such that they cannot tolerate lying still for multiple time point imaging procedures, etc.\n4. Residual toxicity ≥ Grade 2 from prior anti-cancer therapy (except alopecia and peripheral sensory neuropathy).\n5. History of uncontrolled allergic reactions and\u002For known or expected hypersensitivity to protein therapeutics, 177Lu-BetaBart, or any of its excipients.\n6. Inadequate organ functions as reflected in laboratory parameters:\n\n   * Estimated glomerular filtration rate (eGFR) \\\u003C 50 mL\u002Fmin adjusted for participant's body surface area using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI 2021) formula\n   * Platelet count of \\\u003C 100 x 109\u002FL\n   * Absolute neutrophil count (ANC) \\\u003C 1.5 x 109\u002FL\n   * Hemoglobin \\\u003C 9 g\u002FdL\n   * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 x upper limit of normal (ULN), or \\> 5 x ULN for participants with known liver metastases\n   * Total bilirubin \\> 1.5 x ULN, except for participants with documented Gilbert's syndrome who are eligible if total bilirubin ≤ 3 x ULN\n   * For participants not taking warfarin or other anticoagulants: INR ≤1.5 or PT ≤1.5 x ULN; and either PTT or aPTT ≤1.5 x ULN. Participants taking warfarin must be on a stable dose that results in a stable INR \\\u003C3.5. Among participants receiving other anticoagulant therapy, PT or aPTT must be within the intended therapeutic range of the anticoagulant.\n7. Participants requiring blood product transfusion within 2 weeks of first dose of 177Lu-BetaBart are not eligible to participate.\n8. \\*Participants with CRPC who have received prior Lu-177-PSMA radioligand therapy.\n9. Clinically significant cardiovascular disease including but not limited to:\n\n   * Unstable angina\n   * Acute myocardial infarction within 6 months prior to screening\n   * New York Heart Association (NYHA) Class II or greater congestive heart failure\n   * Clinically significant abnormalities in rhythm, conduction or morphology on resting ECG (e.g., complete left bundle branch block, third degree heart block)\n   * Known left ventricular ejection fraction \\\u003C 50%\n   * QTcF \\> 480 msec on screening electrocardiogram (ECG), or congenital long QT syndrome.\n10. Participation in any other interventional investigational trial for treatment of underlying malignancy at the time of informed consent signature.\n11. Participants who are pregnant or breastfeeding.\n12. Major surgery within 4 weeks prior to first dose of 177Lu-BetaBart.\n13. Received anti-cancer therapy, including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy or investigational device, ≤ 28 days (or 5 half-lives for biologic\u002Fnon-cytotoxic agents, whichever is shorter), prior to the first dose of 177Lu-BetaBart.\n14. Known active hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n\n    * Active viral (any etiology) hepatitis participants are excluded.\n    * Participants with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen test and a positive anti hepatitis core antigen antibody test) who have a viral load below the limit quantification (HBV DNA titer \\\u003C 1000 cps\u002FmL or 200 IU\u002FmL) and are not currently on viral suppressive therapy may be eligible and should be discussed with the Sponsor's Medical Monitor (or designee).\n    * Note, participants with a history of HCV infection should have completed curative antiviral treatment and have a viral load below the limit of quantification to be eligible to enroll into the study.\n    * No testing for HBV or HCV is required unless mandated by local health authority.\n15. Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy.\n16. Untreated moderate to severe hydronephrosis. If hydronephrosis is corrected via stent or nephrostomy, hydronephrosis will be considered resolved.\n17. \\*Prescence of a superscan by nuclear medicine\u002F99mTc bone scan.\n18. Active autoimmune disease that has required systemic treatment within 90 days (i.e., with the use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid \\[stable \u002F low doses of ≤10 mg\u002Fday prednisone or equivalent dose\\]) for adrenal or pituitary insufficiency is allowed.\n19. Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of the investigator could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the subject to safety risks.",{"count":127,"type":21},61,[66,24],"A Phase 1\u002F2a Dose Escalation and Expansion Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients with Relapsed\u002FRefractory, Locally Advanced Inoperable, or Metastatic Solid Tumors",[27,131,132,133,134,135,136,137,138,139],"Colorectal Cancer","NSCLC (Non-small Cell Lung Cancer)","Ovarian Cancer","Cervical Cancer","Endometrial Cancer","TNBC, Triple Negative Breast Cancer","Small Cell Lung Cancer (SCLC )","Head &Amp; Neck Squamous Cell Carcinoma (HNSCC)","Esophageal Squamous Cell Carcinoma (ESCC)",[141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157],"Castration-resistant prostate cancer (CRPC)","colorectal cancer (CRC)","non-small-cell lung cancer (NSCLC)","small-cell lung cancer (SCLC)","head and neck squamous cell carcinoma (HNSCC)","ovarian cancer","cervical cancer","endometrial cancer","triple negative breast cancer (TNBC)","esophageal squamous cell carcinoma (ESCC)","B7-H3","177Lu","radiotheranostics","radioligand therapy","radioimmunotherapy","monoclonal antibody","metastatic solid tumors","2026-03-24",{"date":160,"type":46},"2026-03-27",{"date":162,"type":46},"2026-02-23",{"date":83,"type":21},{"name":165,"class":53},"Radiopharm Theranostics, Ltd","Castration Resistant Prostate Cancer (CRPC)"]