[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SCRI Development Innovations, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":226},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,54,89,120,161,192],{"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":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100593833","phase-2-a-study-of-fruquintinib-plus-folfiri-as-second-line-treatment-for-participants-with-metastatic-colorectal-cancer-fruitful-100593833",false,"NCT07011576","A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)","A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)","FRUITFUL","Key Inclusion Criteria:\n\n* Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1.\n* Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600\n* Participants must have received first-line therapy for mCRC that included oxaliplatin, a fluoropyrimidine, and a BEV-based agent. FOLFOXIRI, BEV, and SOX\u002FBEV regimes are not permitted. A minimum of 2 cycles of first line of therapy must have been completed.\n* At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2\n\nKey Exclusion Criteria:\n\n* Current treatment with other anticancer treatments within 21 days of the first dose of study treatment\n* Major surgery within 4 weeks of the first planned dose of study treatment\n* More than one prior systemic treatment for mCRC or any prior systemic treatment including FOLFIRI or irinotecan-based therapy.\n* Participants who received oxaliplatin and fluoropyrimidine in the first line neoadjuvant or adjuvant setting (prior to Metastatic diagnosis) and progressed within 6 months are not eligible due to lack of BEV exposure.\n* Uncontrolled, symptomatic brain metastases\n* Uncontrolled, symptomatic gastrointestinal disease\n* Participants with uncontrolled hypertension\n* Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 6 months after the last administration of study chemotherapy\n* Men who plan to father a child while in the study and for at least 6 months after the last administration of study chemotherapy\n* Documented major electrocardiogram (ECG) abnormalities which are clinically significant.\n* Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment\n* Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC). The main goals of this study are to:\n\n* Evaluate the efficacy of the combination of fruquintinib + FOLFIRI in the 2nd-line mCRC setting\n* Evaluate the safety of the combination of fruquintinib + FOLFIRI",[27,28,29,30],"Colon Cancer","Rectal Cancer","Colorectal Cancer","Colorectal Cancer (CRC)",[32,27,33,34,35,36,37,38,39,40],"Colorectal cancer","Rectal cancer","Metastatic colorectal cancer","mCRC","VEGFR inhibitor","Fruquintinib","FOLFIRI","Second line","2L mCRC","RECRUITING","2026-06-10",{"date":44,"type":45},"2026-06-12","ACTUAL",{"date":47,"type":45},"2025-09-29",{"date":49,"type":21},"2027-06",{"name":51,"class":52},"SCRI Development Innovations, LLC","OTHER",14,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":65,"conditions":66,"keywords":71,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":4},"100642899","phase-2-a-study-of-elranatamab-outpatient-administration-in-patients-with-relapsedrefractory-multiple-myeloma-100642899","NCT07637578","A Study of Elranatamab Outpatient Administration in Patients With Relapsed\u002FRefractory Multiple Myeloma","A Phase II, Nonrandomized, Single-Arm Study of Elranatamab Outpatient Administration in Patients With Relapsed\u002FRefractory Multiple Myeloma (CORE-MM)","CORE-MM","Inclusion Criteria:\n\n1. Written informed consent, according to institutional guidelines, signed and dated by the participant or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses\n2. At least 18 years-of-age at the time of signature of the ICF\n3. Has documented diagnosis of MM according to IMWG diagnostic criteria\n4. Measurable disease at screening, as assessed by local laboratory, defined by any of the following:\n\n   1. Serum M-protein level ≥0.5 g\u002FdL\n   2. Urine M-protein level ≥200 mg\u002F24 hours\n   3. Light chain MM without measurable M-protein in the serum or the urine: serum free light chain (sFLC) ≥10 mg\u002FdL and abnormal serum immunoglobulin kappa lambda FLC ratio\n   4. For participants without measurable disease in the serum, urine, or involved FLC, presence of plasmacytomas (≥2 cm x 1 cm)\n5. Relapsed and\u002For refractory MM received ≥1 prior line of therapy and must have been exposed to both lenalidomide and an anti-CD38 monoclonal antibody (in the same or separate prior lines)\n6. ECOG Performance Status score of 0 or 1\n7. Human immunodeficiency virus (HIV)-positive participants are eligible if they meet all of the following:\n\n   1. No detectable viral load (i.e., \\\u003C50 copies\u002FmL) at screening\n   2. CD4+ count \\>300 cells\u002Fmm3 at screening\n   3. No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 6 months of screening\n   4. Receiving highly active antiretroviral therapy (HAART). Any changes in HAART due to resistance\u002Fprogression should occur at least 3 months prior to enrollment. A change in HAART due to toxicity is allowed up to 4 weeks prior to enrollment. HAART that could interfere with study treatment is excluded (consult the Medical Monitor for a review of medications prior to enrollment, if needed).\n8. Adequate organ function, defined as follows:\n\n   1. Hemoglobin (Hgb) ≥8 g\u002FdL (≥5 mmol\u002FL; without prior red blood cell \\[RBC\\] transfusion within 7 days before laboratory testing; recombinant human erythropoietin use is permitted)\n   2. Platelets \\>50 x109\u002FL\n   3. Absolute neutrophil count (ANC) ≥10.x109\u002FL (prior growth factor support is permitted but must be without support for 7 days for G-CSF or GM-CSF and for 14 days for pegylated G-CSF)\n   4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5xupper limit of normal (ULN)\n   5. Estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin based on Modified Diet in Renal Disease (MDRD) 4-variable formula calculation or creatinine clearance measured by 24-hour urine collection\n   6. Total bilirubin \\\u003C1.5xULN (isolated total bilirubin) ≥1.5xULN with conjugated \\[direct\\] bilirubin \\\u003C1.5xULN is allowed for those participants with known congenital nonhemolytic hyperbilirubinemias)\n   7. Corrected serum calcium ≤14 mg\u002FdL (≤3.5 mmol\u002FL) or free ionized calcium ≤6.5 mg\u002FdL (≤1.6 mmol\u002FL)\n9. Participants must be able and willing to receive prophylaxis for Varicella zoster virus (VZV) and Pneumocystis jirovecii pneumonia (PJP) as follows:\n\n   1. VZV prophylaxis (e.g. acyclovir or valacyclovir) must be initiated prior to or on Day 1 of study treatment, continued throughout the treatment period, and maintained for at least 3 months after the final dose\n   2. PJP prophylaxis must likewise be initiated prior to or on Day 1 of study treatment, continued throughout the treatment period, and maintained for at least 3 months after the final dose\n10. A woman of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and again within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study.\n11. A woman must be:\n\n    a. Not of childbearing potential, or b. Of childbearing potential and practicing true abstinence; or i. Have a sole partner who is vasectomized; or ii. Practicing ≥1 highly-effective, user-independent method of contraception. R\n12. A woman must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for 4 months after receiving the last dose of study treatment.\n13. A man must wear a condom (with or without spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 90 days after receiving the last dose of study treatment. If a female partner is of childbearing potential, she must also be practicing a highly effective method of contraception.\n14. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study treatment.\n\nExclusion Criteria:\n\n1. History of antitumor therapy as follows, before the first dose of study drug\n\n   1. Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is shorter.\n   2. Monoclonal antibody treatment for MM within 21 days.\n   3. Cytotoxic therapy within 21 days.\n   4. PI therapy within 14 days.\n   5. Immunomodulatory agent therapy within 7 days.\n   6. Radiotherapy within 14 days or focal radiation within 7 days.\n   7. Prior gene modified adoptive cell therapy (e.g., chimeric antigen receptor modified \\[CAR\\]-T cells) ≤12 weeks before the first dose of study drug\n2. Has received any of the following:\n\n   1. Packed red blood cells within the last 7 days prior to dosing\n   2. Platelet transfusions within the last 7 days prior to dosing\n   3. Live vaccine within 1 month prior to screening or plans to receive a live vaccine during the study\n3. History of Grade ≥3 CRS or ICANS with prior therapies.\n4. Current treatment with strong or moderate inducers of cytochrome P450 (CYP) 3A4 (CYP3A4) that cannot be discontinued at least 7 days prior to the start of elranatamab treatment and during the study.\n5. Has myelodysplastic syndrome or active malignancies (i.e., progressing or requiring treatment change in the last 12 months) other than RRMM. The only allowed exceptions are:\n\n   a. Malignancies treated within the last 12 months and considered at very low risk for recurrence: i. Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, \\\u003C3 cm, no CIS).\n\n   ii. Skin cancer (non-melanoma or melanoma). iii. Noninvasive cervical cancer. iv. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, localized breast cancer and receiving antihormonal agents.\n\n   v. Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP\u002FRT\u002Ffocal treatment).\n\n   b. Other malignancy that is considered at minimal risk of recurrence. In the event of any questions, consult with the Medical Monitor prior to enrolling a participant.\n6. Has active autoimmune disease or documented history autoimmune disease with exception of vitiligo, type I diabetes mellitus, or prior autoimmune thyroiditis currently euthyroid based on symptoms and labs.\n7. Has active plasma cell leukemia (≥20% peripheral blood plasma cells and ≥2.0×109\u002FL plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.\n8. Any of the following cardiac criteria currently or within the last 6 months:\n\n   1. Have documented major electrocardiogram (ECG) abnormalities which are clinically significant at the Investigator's discretion (for example, symptomatic or sustained atrial or ventricular arrhythmias, second- or third-degree atrioventricular block, bundle-branch blocks, ventricular hypertrophy, or recent myocardial infarction or a mean QTc of \\>470 ms \\[calculated using Fridericia's Correction, confirmed by triplicate ECG\\])\n   2. Cardiac function: left ventricular ejection fraction (LVEF) assessed by ECHO or MUGA \\\u003C45% (evaluation based on institutional lower limit of normal) and the patient has a significant cardiac history, or the investigator suspects ongoing cardiac pathology\n   3. Have the presence of cardiac disease, including a myocardial infarction or any other arterial thrombotic event including cerebrovascular accident or transient ischemic attack within 6 months prior to enrollment, unstable angina pectoris, New York Heart Association (NYHA) Class III-IV congestive heart failure, aneurysm of major vessels or heart, uncontrolled hypertension.\n   4. Overall cardiac ineligibility determined by the Investigator based on medical history and clinically indicated evaluations\n9. Any significant neurologic or psychiatric conditions diagnosed and\u002For ongoing in the last 6 months prior to anticipated treatment start date including but not limited to severe brain injury, stroke, intracranial hemorrhage, seizure, dementia, or Parkinson's disease. Participants with a history of uncontrolled epilepsy requiring anticonvulsants are excluded if therapy not stable within 6 months prior to enrollment.\n10. Active central nervous system (CNS) multiple myeloma involvement.\n11. Has fever or active infection (bacterial, viral, or uncontrolled systemic fungal) at time of study enrollment.\n12. Has hepatitis B infection (i.e., HBsAg or HBV-DNA positive). In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status. See Section 7.4.7 for further required assessments.\n13. Has active hepatitis C infection as measured by positive HCV-RNA testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic hepatitis C infection (defined as both HCV antibody and HCV-RNA positive) completed antiviral therapy and has undetectable HCV-RNA 12 weeks following the completion of therapy, the participant is eligible for the study.\n14. Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 4 months after the last administration of study treatment.\n15. Men who plan to father a child while in the study and for at least 6 months after the last administration of study treatment.\n16. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection, including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required.\n17. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and\u002For follow-up procedures outlined in the protocol.",{"count":63,"type":21},46,[24],"This is a Phase II, open-label, nonrandomized, single-arm study of elranatamab that will be administered in the outpatient setting in 2 sequential cohorts of participants with relapsed or refractory multiple myeloma (RRMM). The primary objective of this study is to evaluate the overall incidence of cytokine release syndrome (CRS) during Cycle 1 of elranatamab treatment following a single prophylactic dose of tocilizumab.",[67,68,69,70],"Multiple Myeloma (MM)","Multiple Myeloma Refractory","Multiple Myeloma in Relapse","Multiple Myeloma",[70,72,73,74,75,76,77,78,79],"MM","RRMM","Relapsed multiple myeloma","Refractory multiple myeloma","Relapsed or refractory multiple myeloma","Elranatamab","Tocilizumab","T-cell engager","NOT_YET_RECRUITING","2026-06-09",{"date":83,"type":45},"2026-06-11",{"date":85,"type":21},"2026-08",{"date":87,"type":21},"2030-02",{"name":51,"class":52},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":17,"minAge":97,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100591004","phase-2-frontline-t-cell-engager-vs-autologous-stem-cell-transplant-asct-and-measurable-residual-disease-mrd-guided-sequential-intensification-therapy-in-multiple-myeloma-100591004","NCT06974786","Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma","Frontline T-cell Engager vs Autologous Stem Cell Transplant and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma (FASTER)","FASTER","Inclusion Criteria:\n\n1. Age \\>18 years with no upper age limit.\n2. Newly diagnosed multiple myeloma with indication for initiation of therapy diagnosed within last 12 months. Pretreatment parameters necessary for disease characterization and response assessment must be available.\n3. Eligible for ASCT according to institutional policy as evaluated by investigator.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix A).\n5. Prior induction therapy including one PI, lenalidomide, and an anti-CD38 mAb for 16-24 weeks, obtaining at least a partial response (PR).\n6. Measurable disease meeting at least 1 of the following criteria (at the time of diagnosis):\n\n   a. Serum monoclonal (M) protein ≥1.0 g\u002Fdl (≥0.5 g\u002Fdl if IgA, IgD, IgE or IgM MM).\n\n   b. ≥200 mg of M protein\u002F24h in the urine. c. Difference between affected and unaffected free light chain ≥10 mg\u002FdL with abnormal kappa to lambda ratio.\n7. Have trackable clonogenic sequence using ClonoSEQ® (Seattle, WA) identified from a high disease burden sample obtained as SoC and enabling MRD testing during screening phase.\n8. Have clinical laboratory values meeting the following criteria during the Screening Phase and also at start of administration of study treatment:\n\n   • Hemoglobin ≥8g\u002FdL without prior red blood cells (RBC) transfusion within 14 days before the laboratory test; recombinant human erythropoietin use is permitted\n\n   • Platelets ≥75,000\u002Fµl\n\n   • Absolute neutrophil count ≥1,000\u002Fµl (prior growth factor support is permitted but must be without support for 7 days for granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating Factor (GM-CSF) and for 14 days for pegylated G-CSF before screening lab test\n\n   • Aspartate aminotransferase and alanine aminotransferase ≤2.5 × upper limit of normal (ULN)\n   * Renal function: Creatinine clearance (CrCl) ≥40 mL\u002Fmin based on calculation using Cockcroft-Gault formula or measured by a 24-hour urine collection.\n   * Total bilirubin ≤2 × ULN, except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤3 × ULN is required)\n   * Serum calcium corrected for albumin ≤14 mg\u002FdL (≤3.5 mmol\u002FL) or free ionized calcium ≤6.5 mg\u002FdL (≤1.6 mmol\u002FL)\n9. Achievement of at least PR to induction therapy, without prior progression of disease.\n10. Prior completion of standard of care mobilization and collection of stem cells (minimum 2 × 106 CD34+ cells\u002Fkg) without use of chemotherapy mobilization, any time prior to or during screening phase.\n11. A woman of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and again within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study.\n12. A woman must be:\n\n    a. Not of childbearing potential, or b. Of childbearing potential and practicing true abstinence; or i. Have a sole partner who is vasectomized; or ii. Practicing ≥1 highly-effective, user-independent method of contraception (Appendix B) NOTE: Participant must agree to continue the above throughout the study and for 4 months after the last dose of study treatment. If a woman becomes of childbearing potential after start of the study the woman must comply with point (b) as described above.\n13. A woman must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for 4 months after receiving the last dose of study treatment.\n14. A man must wear a condom (with or without spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 90 days after receiving the last dose of study treatment. If a female partner is of childbearing potential, she must also be practicing a highly effective method of contraception.\n\n    NOTE: If the male participant is vasectomized, he still must wear a condom (with or without spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository), but his female partner is not required to use contraception.\n15. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study treatment.\n16. Must be willing and able to adhere to the lifestyle restrictions specified in this protocol.\n17. Must sign an Informed Consent Form (ICF) (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n18. All participants must agree to comply with and be enrolled in Revlimid Risk Evaluation and Mitigation Strategy (REMS) program.\n19. All participants must agree to comply with and be enrolled in elranatamab Risk Evaluation and Mitigation Strategy (REMS) program.\n20. All participants must meet institution-specific criteria for ASCT eligibility as assessed by the Investigator.\n\nExclusion Criteria:\n\n1. Diagnosis of primary light chain amyloidosis, POEMS, Waldenstrom's macroglobulinemia, plasma cell leukemia, or central nervous system (CNS) involvement by MM.\n2. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the elranatamab Investigator's Brochure \\[IB\\] and appropriate package inserts).\n3. Prior or concurrent exposure to any of the following:\n\n   c. Any anti-BCMA therapy. d. Epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less.\n\n   e. Investigational vaccine within 4 weeks. f. Live, attenuated vaccine within 4 weeks before randomization. g. Radiotherapy within 14 days. h. Gene-modified adoptive cell therapy (e.g., CAR modified T cells, NK cells). i. Cytotoxic therapy within 14 days.\n4. Minimum washout period for prior therapy:\n\n   1. PI therapy - 14 days.\n   2. IMiD agent therapy -14 days.\n   3. Anti CD38 monoclonal therapy - 14 days.\n   4. Corticosteroids - 7 days.\n5. Known active CNS involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging and lumbar cytology are required.\n6. Myelodysplastic syndrome or active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than MM. The only allowed exceptions are:\n\n   a. Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured.\n\n   b. Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured.\n\n   c. Non-invasive cervical cancer treated within the last 24 months that is considered completely cured.\n\n   d. Localized prostate cancer (N0M0): i. With a Gleason score of ≤6, treated within the last 24 months, or untreated and under surveillance.\n\n1\\) With a Gleason score of 3+4 that has been treated \\>6 months prior to full study screening and considered to have a very low risk of recurrence, or e. History of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence.\n\nf. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence (\\\u003C5% over 5 years).\n\ng. Other malignancy that is considered cured with minimal risk of recurrence. 7. Stroke or seizure within 6 months prior to signing ICF. 8. Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \\\u003C50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is \\\u003C50% of predicted normal.\n\n9\\. Moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study.\n\n10\\. Prior allogeneic bone marrow, hematopoietic stem cell or solid organ transplant.\n\n11\\. Participant is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment.\n\n12\\. Participant plans to father a child while enrolled in this study or within 90 days after the last dose of study treatment.\n\n13\\. Presence of the following cardiac conditions: h. New York Heart Association Class III or IV congestive heart failure i. Myocardial infarction or coronary artery bypass graft ≤6 months prior to randomization j. History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration.\n\nk. History of severe non-ischemic cardiomyopathy. 14. Any of the following:\n\n1. History of Human Immunodeficiency Virus (HIV) infection or Acquired Immunodeficiency Syndrome (AIDS)-related illness.\n2. Active or recent infection (including SARS-COV-2). Participants with prior or recent infection must have infection resolved for \\>21 days and no use of systemic anti-infective therapy for \\>28 days.\n3. Hepatitis B infection (i.e., hepatitis B surface antigen \\[HBsAg\\] or hepatitis B virus \\[HBV\\]-DNA positive). In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status.\n4. Active hepatitis C infection as measured by positive hepatitis C virus (HCV)-RNA testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic hepatitis C infection (defined as both HCV antibody and HCVRNA positive) completed antiviral therapy and has undetectable HCV-RNA for at least 12 weeks following the completion of therapy, the participant is eligible for the study.\n\n   15\\. Major surgery within 14 days prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment.\n\nNOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery. If there is a question whether a procedure is considered a major surgery, the Investigator must consult with the appropriate Sponsor representative and resolve any issues before enrolling a participant in the study.\n\n16\\. Contraindication or intolerance to required supportive care medications in the absence of alternative options.\n\n17\\. Contraindication or intolerance to daratumumab or lenalidomide, or prior to toxicities to lenalidomide during induction requiring reduction of dose to \\\u003C10 mg\u002Fday.\n\n18\\. Significant neuropathy (Grades 3-4 or Grade 2 with pain). 19. History of Guillain-Barre Syndrome or variant. 20. Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the Investigator would constitute a hazard for participating in this study, such as:\n\n1. Uncontrolled diabetes.\n2. Acute diffuse infiltrative pulmonary disease.\n3. History of autoimmune disease with the exception of vitiligo, type I diabetes, and prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing.\n4. Disabling psychiatric conditions (e.g., alcohol or drug abuse), severe dementia, or altered mental status.\n5. Any other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n6. History of non-compliance with recommended medical treatments.","19 Years",{"count":99,"type":21},100,[24],"This is an open-label, multi-site, Phase II randomized trial with response-adaptive design for newly diagnosed multiple myeloma (NDMM) participants who have had prior induction therapy. The primary objective of this study is to compare the rates of achieving undetectable measurable residual disease (MRD) in the bone marrow with elranatamab and daratumumab employed as post-induction consolidation and maintenance treatment (Arm A) versus autologous stem cell transplant (ASCT) followed by lenalidomide and daratumumab treatment (Arm B).",[103,67],"Multiple Myeloma, Newly Diagnosed",[72,105,106,107,108,79,77,109,110],"Newly diagnosed multiple myeloma","NDMM","MRD","ASCT","Daratumumab","Lenalidomide","2026-06-02",{"date":113,"type":45},"2026-06-04",{"date":115,"type":45},"2025-08-08",{"date":117,"type":21},"2033-04",{"name":51,"class":52},11,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},"100575563","phase-2-bms-986489-atigotatug--nivolumab-vs-durvalumab-in-limited-stage-small-cell-lung-cancer-tigos-ls-100575563","NCT06773910","BMS-986489 (Atigotatug + Nivolumab) vs Durvalumab in Limited-stage Small-cell Lung Cancer (TIGOS-LS)","An Open-label, Randomized Study of BMS-986489 (Atigotatug + Nivolumab Fixed-dose Combination) vs Durvalumab as Consolidation Therapy Following Chemoradiotherapy in Limited-stage Small-cell Lung Cancer (TIGOS-LS)","TIGOS-LS","Inclusion Criteria:\n\n* At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (Appendix A)\n* Histologically or cytologically confirmed pulmonary SCLC, evaluable by RECIST v1.1\n* Limited-stage (LS) disease as determined by positron emission tomography (PET) scan prior to initiation of chemotherapy and radiation therapy\n* Completed concurrent chemotherapy and radiotherapy for LS-SCLC without progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (computed tomography \\[CT\\] scan chest\u002Fabdomen\u002Fpelvis; Appendix B) within 42 days before date of randomization and first dose of study treatment\n\n  * Chemotherapy should consist of a platinum and IV etoposide. Participants who received at least 3 cycles of chemotherapy will be eligible to participate.\n  * Radiotherapy should be administered per institutional guidelines\n* Prophylactic cranial irradiation (PCI) may be delivered at the discretion of the Investigator and institutional guidelines. PCI, if applicable, must be conducted after the end of chemoradiotherapy and completed between 14 and 42 days before date of randomization and first dose of study treatment.\n* Adequate hematologic and organ function\n* Willingness to abide by protocol defined contraceptive requirements for the duration of the study.\n\nExclusion Criteria:\n\n* Small-cell cancer not pulmonary in origin\n* Large cell neuroendocrine carcinoma\n* ES-SCLC\n* Mixed SCLC and NSCLC histologic features; diagnosis of NSCLC; or EGFR-activating, mutation-positive NSCLC that has transformed to SCLC\n* History of severe hypersensitivity reaction to monoclonal antibodies\n* Known hypersensitivity to any excipients of atigotatug, nivolumab, or durvalumab\n* Grade ≥2 peripheral neuropathy by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0\n* Active, prior, or suspected autoimmune disease, including autoimmune neurologic disorders such as paraneoplastic syndrome involving the CNS, peripheral sensory\u002Fmotor nerves, or neuromuscular junction. Exceptions to this criterion include:\n\n  * Type 1 diabetes mellitus\n  * Hypothyroidism requiring only hormone replacement\n  * Skin disorders not requiring systemic treatment\n  * Autoimmune conditions not expected to recur during the study\n* Diseases or conditions requiring chronic systemic corticosteroids (\\>10 mg daily prednisone or equivalent) or other immunosuppressive therapy within 14 days of starting study treatment. Limited-course (\\\u003C2 weeks' duration) oral steroids (10 mg prednisone or equivalent) are permitted. Bronchodilators, inhaled or topical steroids, and adrenal replacement steroid doses \\>10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.\n* History of solid organ or bone marrow transplantation\n* History of Grade ≥2 pneumonitis (excepting resolved infective pneumonitis)\n* Any of the following cardiac criteria, currently or within the last 3 months:\n\n  * Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third-degree heart block, atrial fibrillation not rate controlled. Certain conditions may be considered through discussion with the Medical Monitor.\n  * Congestive heart failure (New York Heart Association \\[NYHA\\] \\> Grade 2) or classified as Class 3 or 4 by the NYHA Functional Classification (Appendix D)\n  * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, uncontrolled hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval (Appendix E). Certain conditions may be considered through discussion with the Medical Monitor.\n  * Participants with a left ventricular ejection fraction \\\u003C55% or the lower limit of normal of the institutional standard\n  * Uncontrolled hypertension, defined as systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>90 mmHg despite optimal medical management\n  * Active coronary artery disease, including unstable or newly diagnosed angina\n  * Myocardial infarction\n  * History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes)\n  * History or current diagnosis of myocarditis\n* As judged by the Investigator, participants with serious or uncontrolled medical disorders\n* Presence of other active invasive cancers. Participants with a previously treated malignancy will be eligible to participate if treatment of that malignancy was completed at least 2 years before date of screening and the participants has no evidence of disease. Exceptions to this criterion include appropriately treated basal cell carcinoma of the skin; in situ carcinoma of uterine cervix; localized prostate cancer that has been definitively treated; or other local tumors considered cured by local treatment.\n* Received sequential chemotherapy and radiotherapy as a definitive treatment for LS-SCLC\n* Treatment with any of the following:\n\n  * Any systemic anticancer chemotherapy, small molecule, biologic, or hormonal agent from a previous treatment regimen or clinical study within 21 days or 5 half-lives (whichever is longer) prior to the first dose of study treatment\n  * Wide-field radiotherapy (including therapeutic radioisotopes such as strontium-89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study treatment or has not recovered from side effects of such therapy\n  * Prior systemic treatment for LS-SCLC, with the exception of chemoradiotherapy and PCI\n  * Prior treatment with an anti-PD-1, anti-PD-L1, anti-programmed cell death ligand 2 (anti-PD-L2), anti-CD137, anti-cytotoxic T-lymphocyte associated protein 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways\n  * Prior treatment with fuc-GM-1 vaccine or targeted agent or similar vaccine targeting ganglioside antigens\n  * Current treatment with immunosuppressive medications\n  * Live attenuated vaccine within 100 days before first dose of study treatment\n* Major surgery (excluding placement of vascular access) within 4 weeks of date of screening\n* With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment. Note: Participants with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be eligible with approval by the Medical Monitor or Principal Investigator.\n* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and\u002For follow-up procedures outlined in the protocol",{"count":129,"type":21},250,[24],"This is an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab in limited-stage (LS)-small-cell lung cancer (SCLC) participants.\n\nThe main goals of this study are to:\n\n* Evaluate the efficacy of BMS-986489 vs durvalumab\n* Evaluate the safety profile of BMS-986489",[133],"Limited Stage Small Cell Lung Cancer",[135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151],"limited stage small cell lung cancer","limited stage small cell lung carcinoma","LS-SCLC","Limited-stage SCLC","Nivolumab","Opdivo","fucosyl-monosialoganglioside-1","fuc-GM1","programmed cell death protein 1","PD-1 inhibitor","anti-PD-1 antibody","Durvalumab","Imfinzi","PD-L1 inhibitor","Anti-PD-L1 antibody","Limited-stage (LS)-small-cell lung cancer (SCLC)","BMS-986489","2026-04-17",{"date":154,"type":45},"2026-04-22",{"date":156,"type":45},"2025-03-11",{"date":158,"type":21},"2032-09",{"name":51,"class":52},33,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":171,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},"100513950","phase-2-outpatient-administration-of-teclistamab-or-talquetamab-for-multiple-myeloma-100513950","NCT05972135","Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma","Inclusion Criteria:\n\n* Be ≥18 years of age (or the higher legal age in the jurisdiction in which the study is taking place) at the time of informed consent\n* Has documented diagnosis of MM according to the IMWG diagnostic criteria (Rajkumar 2011).\n* Teclistamab or Talquetamab + Tocilizumab: has received 2 or more prior MM therapies including a PI, IMiD and CD38 antibody.\n* Teclistamab + Oral Dexamethasone: has received 1 or more prior MM therapies including a PI, IMiD and\u002For CD38 antibody.\n* Teclistamab or Talquetamab + Tocilizumab: has an ECOG performance status (Oken 1982) of 0 to 1.\n\nTeclistamab + Oral Dexamethasone: has an ECOG performance status (Oken 1982) of 0 to 2.\n\n* Measurable disease at screening, as assessed by local laboratory, defined by any of the following:\n\n  * Serum M-protein level ≥0.5 g\u002FdL; or\n  * Urine M-protein level ≥200 mg\u002F24 hours; or\n  * Light chain MM without measurable M-protein in the serum or the urine: serum free light chain (sFLC) ≥10 mg\u002FdL and abnormal serum immunoglobulin kappa lambda FLC ratio.\n  * For participants without measurable disease in the serum, urine, or involved FLC, presence of plasmacytomas (≥2 cm).\n* Human immunodeficiency virus-positive participants are eligible if they meet all of the following:\n\n  * No detectable viral load (i.e., \\\u003C50 copies\u002FmL) at screening\n  * CD4+ count \\>300 cells\u002Fmm3 at screening\n  * No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 6 months of screening\n  * Receiving highly active antiretroviral therapy (HAART). Any changes in HAART due to resistance\u002Fprogression should occur at least 3 months prior to enrollment. A change in HAART due to toxicity is allowed up to 4 weeks prior to enrollment.\n* Adequate organ system function\n* Body weight \\>35 kg.\n* A participant of childbearing potential must have a negative highly sensitive serum (β-hCG) at screening and within 72 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study.\n* A participant must agree to abide by protocol defined contraceptive requirements for the duration of the study including avoiding donating gametes for specified period of time.\n* A participant must sign an ICF indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n* A participant is required to stay within 60 minutes of transportation to the site and remain in the company of a competent adult at all times until 48 hours following administration of all doses within the teclistamab step-up dosing schedules\n* A participant is required to stay within 30 minutes of transportation to the site and remain in the company of a competent adult at all times until 48 hours following administration of all doses within the talquetamab step-up dosing schedule\n* A participant must agree to carry the study participant identification wallet card at all times.\n* A participant must comply with all the protocol requirement procedures, including measuring and recording of body temperature and blood oxygen saturation twice daily (≥8 hours apart) during the first 2 cycles of teclistamab or talquetamab treatment and coming to the study site for safety assessments.\n* A participant and the accompanying competent adult must be made aware of the presenting sign sand symptoms of teclistamab- or talquetamab- associated toxicities, including but not limited to CRS, ICANS, infections, etc. The accompanying competent adult must watch the participant at all times for teclistamab- or talquetamab- associated toxicities, until 48 hours after the first treatment dose of teclistamab or talquetamab.\n\nExclusion Criteria:\n\n* Has a rapidly progressing disease per investigator assessment.\n* Has plasma cell leukemia (\\>2.0×10\\^9\u002FL plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.\n* Has known active CNS involvement or exhibits clinical signs of meningeal involvement of MM.\n* Has risk factors for developing clinically significant TLS and requiring management with increased hydration, allopurinol, or rasburicase.\n* Has myelodysplastic syndrome or active malignancies (ie, progressing or requiring treatment change in the last 12 months) other than RRMM. The only allowed exceptions are:\n\n  * Any malignancy that was not progressing nor requiring treatment change in the last 12 months.\n  * Malignancies treated within the last 12 months and considered at very low risk for recurrence:\n  * Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, \\\u003C3 cm, no CIS).\n  * Skin cancer (non-melanoma or melanoma).\n  * Noninvasive cervical cancer.\n  * Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, localized breast cancer and receiving antihormonal agents.\n  * Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP\u002FRT\u002Ffocal treatment).\n  * Other malignancy that is considered at minimal risk of recurrence.\n* Has Grade ≥3 hematologic AEs or Grade ≥3, clinically significant non-hematologic AEs.\n* Has fever or active infection (bacterial, viral, or uncontrolled systemic fungal) at time of study enrollment.\n* Has active autoimmune disease or a documented history of autoimmune disease with the exception of vitiligo, type I diabetes, and prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing.\n* Has clinically significant coagulopathy that would increase the risk of bleeding in the setting of cytopenia.\n* Shows a deterioration in neurologic status, including mental status changes such as confusion or increased somnolence.\n* Has psychiatric disorders (eg, alcohol or drug abuse), dementia, or altered mental status that would compromise the ability to provide informed consent or comply with the clinical protocol.\n* History of stroke, transient ischemic attack or seizure within 6 months of signing ICF.\n* Presence of the following cardiac conditions:\n\n  * New York Heart Association stage III or IV congestive heart failure.\n  * Myocardial infarction or CABG ≤6 months prior to enrollment.\n  * History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration.\n  * History of severe non-ischemic cardiomyopathy.\n  * Poorly controlled coronary artery disease and\u002For congestive heart failure.\n  * Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities.\n* Has hepatitis B infection (ie, HBsAg or HBV-DNA positive). In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status.\n* Has active hepatitis C infection as measured by positive HCV-RNA testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic hepatitis C infection (defined as both HCV antibody and HCV-RNA positive) completed antiviral therapy and has undetectable HCV-RNA 12 weeks following the completion of therapy, the participant is eligible for the study.\n* Has COPD with FEV1 \\\u003C50% of predicted.\n* Has eGFR \\\u003C20 ml\u002Fmin or is dependent on dialysis.\n* Has other medical issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n* For talquetamab arm only: Prior Grade 3 or higher CRS related to any T-cell redirection (e.g., CD-3 redirection technology or CAR-T cell therapy), or any prior GPRC5D-targeting therapy.\n* Has received packed RBC or platelet transfusions within the last 7 days prior to dosing.\n* Has contraindications to the use of tocilizumab or IVIG per local prescribing information.\n* Has received live vaccine(s) within 1 month prior to screening or plans to receive live vaccines during the study.\n* Has received live, attenuated vaccine(s) within 30 days before the first dose of teclistamab or talquetamab. Live, attenuated influenza vaccines are permitted as late as 30 days before the study treatment.\n* Has received any non-anti-cancer investigational intervention or used any non-anti-cancer invasive investigational medical device within 21 days before the planned first dose of study treatment or received any non-anti-cancer investigational biological product within 21 days or 5 half-lives, whichever is shorter, before the planned study treatment, or is currently enrolled in an investigational study.\n* History of prior anti-cancer therapy as follows, before the first dose of study drug:\n\n  * Targeted therapy, epigenetic therapy, or treatment with an investigational anti-cancer drug or used an invasive investigational medical device within 21 days or 5 half-lives, whichever is shorter.\n  * Monoclonal antibody treatment for MM within 21 days.\n  * Cytotoxic therapy within 21 days.\n  * PI therapy within 14 days.\n  * Immunomodulatory agent therapy within 7 days.\n  * Radiotherapy within 14 days or focal radiation within 7 days.\n  * For teclistamab arms only: Prior Gene modified adoptive cell therapy (eg, chimeric antigen receptor modified \\[CAR\\]-T cells, NK cells, or BCMA therapy)\n  * For talquetamab arm only: Prior CAR-T or BCMA bispecific antibody therapy are allowed with the appropriate wash-out period: 1) Gene modified adoptive cell therapy (eg, chimeric antigen receptor modified \\[CAR\\]-T cells, NK cells) within 3 months, or 2) BCMA therapies (antibody-drug conjugates and bispecific antibodies, etc) within 21 days or at least 5 half-lives, whichever is less.\n* History of stem cell transplant:\n\n  * An allogeneic stem cell transplant within 6 months. Participants who received an allogeneic transplant must be off all immunosuppressive medications for ≥42 days without signs of graft-versus-host disease.\n  * An autologous stem cell transplant ≤12 weeks before the first dose of study drug.",{"count":99,"type":21},[24],"This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients",[70],[172,173,174,175,176,177,178,179,180,181,182,183,184],"Teclistamab (TECVAYLI™)","Humanized IgG-4 PAA bispecific antibody","CD3 receptor complex","RRMM-Relapsed or Refractory Multiple Myeloma","MM-Multiple Myeloma","Tocilizumab prophylaxis","CRS- Cytokine Release Syndrome","Neurologic toxicity","ICANS-Immune Effector Cell-associated Neurotoxicity Syndrome","Talquetamab (TALVEY™)","GPRC5D","BCMA","Oral dexamethasone prophylaxis",{"date":154,"type":45},{"date":187,"type":45},"2023-10-23",{"date":189,"type":21},"2027-10",{"name":51,"class":52},17,{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":225},"100496791","phase-2-study-of-tucatinib-and-doxil-in-participants-with-human-epidermal-growth-factor-receptor-2-positive-her2-metastatic-breast-cancer-100496791","NCT05748834","Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer","Phase 2 Single Arm Trial With a Safety Lead-in of Tucatinib in Combination With Doxil for the Treatment of HER2+ Metastatic Breast Cancer","Inclusion Criteria:\n\n* Written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses\n* At least 18 years-of-age at the time of signature of the informed consent form (ICF)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1\n* Have a confirmed diagnosis of locally advanced\u002Fmetastatic HER2+ breast cancer (based on local laboratory testing per American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines immunohistochemistry 3+ (IHC3+) or fluorescence in situ hybridization + (FISH+))\n* Have had prior treatment with at least 1 line of anti-HER2 therapy for locally advanced\u002Fmetastatic disease or relapsed within 6 months of completion of adjuvant anti-HER2 therapy. Prior treatment with tucatinib in the metastatic setting is allowed\n* Measurable disease as measured by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1\n* Females of child-bearing potential should be using adequate contraceptive measures from the time of screening until 6 months following the last dose of study drug(s), should not be breast feeding and must have a negative pregnancy test prior to start of dosing, or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:\n\n  * Post-menopausal: defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments\n  * Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation\n  * Women under 50 years-of-age will be considered postmenopausal if they have been amenorrheic for at least 12 months following the cessation of exogenous hormonal treatments, and have serum follicle-stimulating hormone and luteinizing hormone levels in the postmenopausal range for the institution.\n* Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 6 months following last dose. Male patients must also refrain from donating sperm during their participation in the study.\n* Adequate hematologic function\n\n  * Absolute neutrophil count (ANC) ≥1500\u002FµL\n  * Platelet count ≥100,000\u002FµL (no transfusions allowed to meet this requirement)\n  * Hemoglobin ≥9 g\u002FdL (at least 2-week washout from any transfusion)\n* Adequate hepatic function\n\n  * Total bilirubin ≤1.5 × upper limit of normal (ULN). Exception: participants with known history of Gilbert's Syndrome who have a direct bilirubin ≤1.5 × ULN in addition to a normal aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are eligible.\n  * AST and ALT ≤2.5 × ULN (≤5 × ULN if liver metastases are present)\n* Estimated glomerular filtration rate (eGFR) ≥50 mL\u002Fmin\u002F1.73 m2\n* Left ventricular ejection fraction (LVEF) ≥50% based on screening echocardiogram (ECHO)\u002Fmultigated acquisition (MUGA)\n* Central nervous system (CNS) Inclusion - Based on screening contrast brain magnetic resonance imaging (MRI), patients must have one of the following:\n\n  * No evidence of brain metastases\n  * Untreated brain metastases not needing immediate local therapy. For patients with untreated CNS lesions \\>2.0 cm on screening contrast brain MRI, discussion with and approval from the Medical Monitor is required prior to enrollment.\n  * Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions.\n  * Previously treated brain metastases:\n* Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy in the opinion of the Investigator.\n* Patients treated with CNS local therapy for newly identified lesions found on contrast brain MRI performed during screening for this study may be eligible to enroll if all of the following criteria are met:\n* Time since whole brain radiotherapy (WBRT) is ≥14 days prior to first dose of treatment, time since stereotactic radiosurgery (SRS) is ≥7 days prior to first dose of treatment, or time since surgical resection is ≥28 days\n* Other sites of disease assessable by RECIST 1.1 are present\n\nExclusion Criteria:\n\n* Treatment with any of the following:\n\n  * Any systemic anti-cancer chemotherapy or small molecule, biologic, or hormonal agent from a previous treatment regimen or clinical study within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of study drugs. At least 10 days must have elapsed between the last dose of such agent and the first dose of study drugs.\n  * Prior treatment with anthracycline in any setting\n  * Major surgery (excluding placement of vascular access) within 28 days of first dose of study drugs\n  * Palliative radiation therapy within 14 days of first dose of study drugs\n* Based on screening brain MRI, patients must not have any of the following:\n\n  * Any untreated brain lesions \\>2.0 cm in size, unless discussed with the Medical Monitor and approval for enrollment is granted\n  * Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \\>2 mg of dexamethasone (or equivalent). However, patients on a chronic stable dose of ≤2 mg total daily of dexamethasone (or equivalent) may be eligible with discussion and approval by the Medical Monitor\n  * Any brain lesion thought to require immediate local therapy, including (but not limited to) a lesion in an anatomic site where increase in size or possible treatment-related edema may pose risk to patient (e.g., brain stem lesions). Patients who undergo local treatment for such lesions identified by screening contrast brain MRI may still be eligible for the study based on criteria described under CNS inclusion criteria 14c\n  * Known or suspected leptomeningeal disease (LMD) as documented by the Investigator\n  * Have poorly controlled (\\>1 week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases, notwithstanding CNS-directed therapy.\n* Use of a strong cytochrome P450 (CYP)2C8-inhibitor or use of a strong CYP3A4 or use of a CYP2C8 inducer within 5 days prior to the first dose of study treatment\n* With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment. Note: patients with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be eligible with approval by the Medical Monitor.\n* Women who are pregnant or nursing or plan to become pregnant while in the study and for at least 6 months after the last administration of study treatment\n* Men who plan to father a child while in the study and for at least 6 months after the last administration of study treatment\n* Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of tucatinib (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea Grade ≥2, malabsorption syndrome)\n* Any of the following cardiac criteria:\n\n  * Mean resting QT interval with QT corrected for heart rate by Fridericia's formula \\[QTcF\\]) prolongation to \\>480 msec for females and \\>460 msec for males in three successive screening measures\n  * Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third-degree heart block\n  * Congestive heart failure (New York Heart Association ≥ Grade 2 within past 6 months)\n  * Patients with a left ventricular ejection fraction (LVEF) \\\u003C50% or the lower limit of normal of the institutional standard\n* As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection, including hepatitis B and hepatitis C. Screening for chronic conditions is not required.\n* Known human immunodeficiency virus (HIV) infection or positivity on immunoassay. Testing for seropositive status during screening will be at the discretion of the Investigator for subjects without previously reported results.\n* Presence of other active invasive cancers other than the one treated in this study within 3 years prior to screening, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment\n* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and\u002For follow-up procedures outlined in the protocol.",{"count":200,"type":21},36,[24],"This clinical trial is evaluating tucatinib in combination with Doxil in participants with human epidermal growth factor 2 positive (HER2+) locally advanced or metastatic breast cancer. The main goals of this study are to:\n\n* Learn how well the combination of tucatinib and Doxil works\n* Learn more about the side effects of the combination of tucatinib and Doxil",[204],"Breast Cancer",[204,206,207,208,209,210,211,212,213,214,215,216],"HER2+","HER2 positive breast cancer","Human epidermal growth factor receptor 2 positive","Doxil","Tucatinib","Tukysa","Anti-HER2","HER2 inhibitor","HER2 blocker","Tyrosine Kinase Inhibitor","Anthracycline","2026-03-17",{"date":219,"type":45},"2026-03-20",{"date":221,"type":45},"2023-07-24",{"date":223,"type":21},"2027-11",{"name":51,"class":52},8,""]