[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-tumor-adult\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-tumor-adult":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,97,0,25,[9,47,87,112,133,153,174,222,257,310,332,374,406,447,467,490,521,543,575,601,622,651,700,734,757],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":46},"100434863","adapting-for-latinx-populations-an-intervention-that-involves-discussing-and-sharing-patients-health-related-values-100434863",false,"NCT04942717","Adapting for Latinx Populations an Intervention That Involves Discussing and Sharing Patients' Health-Related Values","Communicating With Oncology Nurses About Values From the Outset (CONVO): An Innovative Primary Palliative Care Intervention in English and Espanol","Inclusion Criteria:\n\n* All participants will be adults (age ≥ 21) providing informed verbal consent. We seek a waiver of signed consent, which will allow use of virtual communication during the COVID-19 pandemic period.\n* Patients will be eligible as key informants in the translation\u002Ftranscreation process (Aim 1) if they are receiving medical oncology care for a solid tumor malignancy at RLC, SBH, or Jacobi and speak Spanish as their preferred language. In addition, English-speaking Latinx patients will be eligible to participate in interviews based on the back-translated (Spanish-to-English) version of the Guide\n\n  * We are focusing on patients with solid tumors rather than hematologic malignancies because 1) patients in the latter group may be receiving initial oncologic treatment in the hospital, whereas our study staff will be based at a distance from the hospital in the ambulatory clinics; 2) the trajectory, patient characteristics, and other aspects of hematologic malignancies tend to be different from solid tumor malignancies such that it would be more difficult to understand the overall impact of the intervention if patients with both types of malignancies w ere included.\n* Spanish-speaking family\u002Fother informal caregivers (collectively referred to as \"family\") who accompany participating patients to clinic will also be eligible to participate in interviews as part of the Aim 1 translation\u002Ftranscreation process. These will be individual interviews, conducted separately for patient and family participants.\n* Clinicians eligible for participation in the transcreation will be oncology physicians, nurses and other key clinical staff (e.g. social workers, advance practice providers, etc.) at RLC and other MSK sites who are Latinx and\u002For whose practice includes \\>20% Latinx patients.\n* Site leaders at SBH, Jacobi, and RLC with administrative responsibility for medical oncology will be eligible as key informants in transcreation of CONVO.\n* For the Aim 2 pilot trial, patients will be eligible if they are receiving systemic chemotherapy at SBH or Jacobi for a solid tumor; identify as Latinx; and speak English and\u002For Spanish. Family and\u002For informal caregivers who accompany the patient and speak English and\u002For Spanish will also be eligible (if the patient opts to include the family and\u002For informal caregiver in the CONVO discussion).\n* Nurses providing outpatient oncology care in chemotherapy areas at SBH or Jacobi will be eligible to participate in the pilot trial.\n\nExclusion Criteria:\n\n* Inability to understand consent procedure in either English or Spanish will be an exclusion. (The consenting professional will be bilingual \\[English\u002FSpanish\\] and able to explain and obtain consent in either language.)","ALL","21 Years",{"count":20,"type":21},234,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to translate and tailor for Latinx participants a program called Communicating with Oncology Nurses about Values from the Outset (CONVO). In CONVO, routine cancer care for each participant includes a discussion between the nurse and participant about the participant's health-related values.",[27,28,29],"Solid Tumor","Solid Tumor, Adult","Solid Tumor, Unspecified, Adult",[31,32,27,33,34],"Spanish speaking","Latinx","20-539","Memorial Sloan Kettering Cancer Center","RECRUITING","2026-07-01",{"date":38,"type":39},"2026-07-02","ACTUAL",{"date":41,"type":39},"2021-06-18",{"date":43,"type":21},"2027-06-18",{"name":34,"class":45},"OTHER",5,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":66,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100532907","phase-1-phase-1-study-to-investigate-tcrts-kras-mutation-in-unresectable-advanced-andor-metastatic-solid-tumors-100532907","NCT06218914","Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and\u002For Metastatic Solid Tumors","Open-label, Phase 1, Multi-Center Master Protocol to Evaluate the Safety and Preliminary Anti-Tumor Activity of TCR-engineered T Cells Recognizing KRAS Mutations in Adult Subjects With Unresectable, Advanced, and\u002For Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosed with NSCLC, Colorectal adenocarcinoma, Pancreatic adenocarcinoma, Endometrial Cancer or any other solid tumor\n* Tumors must harbor a KRAS G12D variant mutation and subject must be HLA-C\\*08:02 positive, HLA-A\\*11:01 or HLA-A\\*11:02 positive in at least one allele\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Presence of at least 1 measurable lesion per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment\n\nKey Exclusion Criteria:\n\n* Any other primary malignancy within the 3 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or low-grade prostate cancer\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of stroke or transient ischemic attack within the 12 months prior to enrollment.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* Any form of primary immunodeficiency.\n* Active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy)\n* Female of childbearing potential who is lactating or breast feeding at the time of enrollment\n* Prior treatment with pan-KRAS or KRAS G12D targeting agents unless presence of KRAS G12D mutation is confirmed after the completion of treatment with pan-KRAS or KRAS G12D targeting agents.","18 Years",{"count":56,"type":21},108,[58],"PHASE1","Phase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and\u002For Metastatic Solid Tumors.",[61,62,63,64,28,65],"Non-small Cell Lung Cancer","Colorectal Carcinoma","Pancreatic Ductal Adenocarcinoma","Endometrial Cancer","KRAS G12D",[67,68,65,69,70,71,72,73,63,74,75,76],"TCR-T cell therapy","KRAS","Autologous","PDAC","NSCLC","Colorectal Cancer","Solid tumors","HLA-C*08:02","HLA-A*11:01","HLA-A*11:02","2026-06-30",{"date":36,"type":39},{"date":80,"type":39},"2024-03-22",{"date":82,"type":21},"2043-11-18",{"name":84,"class":85},"AstraZeneca","INDUSTRY",18,{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100512874","phase-1-ima402-t-cell-engaging-receptor-molecule-tcer-in-recurrent-andor-refractory-solid-tumors-100512874","NCT05958121","IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and\u002For Refractory Solid Tumors","A Phase I\u002FII First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) Targeting PRAME, as Monotherapy or in Combination With a Checkpoint Inhibitor in Patients With Recurrent and\u002For Refractory Solid Tumors","Inclusion Criteria:\n\n* Patients ≥ 18 years old\n* Patients must have a specific pathologically confirmed and documented advanced and\u002For metastatic solid tumor indication\n* Patients must have received or not be eligible for indicated standard-of-care treatments per cohort\n* Measurable disease according to RECIST 1.1\n* Confirmed HLA status\n* ECOG Performance Status of 0 to 1\n* Adequate baseline hematologic, hepatic and renal function, acceptable coagulation status\n\nExclusion Criteria:\n\n* Other active malignancies that require treatment or that might interfere with the trial endpoints\n* The patient is pregnant or is breastfeeding\n* History of hypersensitivity to components of IMA402 or rescue medications; hypersensitivity to or contraindication according to current SmPC for respective combination medicinal product\n* The patient has concurrent severe and\u002For uncontrolled medical disease. Any other health condition that would, in the investigator's or sponsor's judgement, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures\n* Patients with active brain metastases, history of bleeding into brain metastases, known brain metastases who are receiving therapeutic anticoagulation",{"count":95,"type":21},400,[58,97],"PHASE2","The goal of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA402 in patients with recurrent and\u002For refractory solid tumors.\n\nPrimary objectives:\n\n* To determine the maximum tolerated doses and\u002For recommended doses for extensions for IMA402 as monotherapy and in combination with pembrolizumab (Phase Ia)\n* To characterize the safety and tolerability of IMA402 as monotherapy and in combination (Phase I\u002FII)\n* To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II)\n\nSecondary objectives:\n\n* To evaluate the initial anti-tumor activity of IMA402 as monotherapy and in combination (Phase I)\n* To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II)\n* To describe the PK of IMA402 as monotherapy and in combination (Phase I\u002FII)",[100,101,28,102],"Refractory Cancer","Recurrent Cancer","Cancer","2026-06-29",{"date":36,"type":39},{"date":106,"type":39},"2023-08-09",{"date":108,"type":21},"2027-09",{"name":110,"class":85},"Immatics Biotechnologies GmbH",29,{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100551646","phase-1-first-in-human-study-of-cx-801-in-advanced-solid-tumors-100551646","NCT06462794","First In Human Study of CX-801 in Advanced Solid Tumors","An Investigational Study of CX-801 as Monotherapy and in Combination With PD1 Inhibition in Participants With Solid Tumors","Inclusion Criteria:\n\n* Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Measurable disease per RECIST v1.1\n* Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue\n* Adequate organ function\n* Additional inclusion criteria may apply\n\nExclusion Criteria:\n\n* Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated\n* Known active central nervous system (CNS) involvement by malignancy\n* Prior PD-1\u002F PD-(L)1 inhibitor treatment discontinued due to grade 3 or higher immune related adverse event\n* Systemic anticancer treatment within 4 weeks or 5 half lives prior to first dose of study treatment\n* Investigational drug or device within 4 weeks prior to first dose of study treatment\n* Radiation within 2 weeks prior to first dose of study treatment\n* Serious concurrent illness\n* Pregnant or breast feeding\n* Additional exclusion criteria may apply",{"count":120,"type":21},121,[58],"The purpose of this first-in-human study, CTMX-801-101, is to characterize the safety, tolerability, and antitumor activity of CX-801 as monotherapy and in combination with pembrolizumab in adult participants with advanced solid tumors.",[28],"2026-06-25",{"date":103,"type":39},{"date":127,"type":39},"2024-08-28",{"date":129,"type":21},"2029-06-30",{"name":131,"class":85},"CytomX Therapeutics",4,{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},"100536504","phase-1-first-in-human-study-of-cx-2051-in-advanced-solid-tumors-100536504","NCT06265688","First In Human Study of CX-2051 in Advanced Solid Tumors","An Investigational Study of CX-2051 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Measurable disease per RECIST v1.1\n* Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue\n* Additional inclusion criteria may apply\n\nExclusion Criteria:\n\n* Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated\n* Known active central nervous system (CNS) involvement by malignancy\n* Systemic anticancer treatment, radiotherapy, or investigational agent(s) within 14 days prior to C1D1\n* Previous treatment with antibody-drug conjugates (ADCs) with Topo-I inhibitor payload\n* Major surgery (requiring general anesthesia) within 4 weeks prior to C1D1\n* Elevated baseline laboratory values\n* Serious concurrent illness\n* Pregnant or breast feeding\n* Additional exclusion criteria may apply",{"count":141,"type":21},160,[58],"The purpose of this first-in-human study, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 as a monotherapy and in combination with bevacizumab in adult participants with advanced solid tumors.",[28],"2026-06-23",{"date":124,"type":39},{"date":148,"type":39},"2024-04-02",{"date":150,"type":21},"2029-03-31",{"name":131,"class":85},7,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"100379336","phase-1-a-study-of-bi-1206-in-combination-with-pembrolizumab-in-subjects-with-advanced-solid-tumors-100379336","NCT04219254","A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors","A Phase 1\u002F2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n* Is willing and able to provide written informed consent for the trial.\n* Is ≥18 years of age on day of signing informed consent.\n* Phase I only: Has a histologically confirmed advanced solid tumor. Subjects must have received at least 2 doses of an approved anti-PD-1\u002FL1 mAb, and have documented progression on or within 12 weeks from the last dose of anti-PD-1\u002FL1 mAb.\n* For patients with NSCLC (phase 2A SC cohorts):\n\nHave a histologically confirmed diagnosis of advanced or metastatic NSCLC and not have an EGFR sensitizing (activating) mutation or an ALK translocation.\n\nHave a PD-L1 positive (TPS≥50%) tumor as determined by IHC at a local laboratory.\n\nHave not received prior systemic immunotherapy or chemotherapy treatment for their advanced\u002Fmetastatic NSCLC.\n\nHave provided formalin-fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of advanced or metastatic disease has been made and from a lesion not previously irradiated to perform biomarker analysis.\n\n• For patients with uveal melanoma (phase 2A SC cohort): Have a histologically confirmed diagnosis of advanced or metastatic uveal melanoma\n\nHave a PD-L1 positive (TPS≥1%) tumor as determined by IHC at a local laboratory.\n\nHave not received prior systemic immunotherapy or chemotherapy treatment for their advanced\u002Fmetastatic uveal melanoma. Subjects who have received previous treatment with tebentafusp and\u002For liver directed therapy are allowed.\n\nHave provided formalin-fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of advanced or metastatic disease has been made and from a site not previously irradiated to perform biomarker analysis.\n\n* Phase I only: Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy.\n* Has at least 1 measurable disease lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)\n* Phase IIa only: Is willing to provide an archival tumor tissue sample or newly obtained \\[core, incisional, OR excisional\\] biopsy of a tumor lesion not previously irradiated.\n* Is able to safely undergo a baseline tumor tissue biopsy prior to first dose of BI-1206.\n* Has a life expectancy of ≥12 weeks.\n* Has an ECOG performance status of 0-1.\n* Has adequate organ function as confirmed by laboratory values listed in the main body of the protocol\n* Phase IIa only: Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to enrolment\n* Phase IIa only: Participants with history of HCV infection are eligible if HCV viral load is undetectable at Screening\n* Phase IIa only: Has adequate hematological and biochemical indices as listed in the main body of the protocol\n\nExclusion Criteria:\n\n* Needs doses of prednisolone \\>10 mg daily (or equipotent doses of other corticosteroids) while on the study, other than as premedication.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Has known or suspected hypersensitivity to pembrolizumab or BI-1206 or any of their excipients.\n* Has cardiac or renal amyloid light-chain (AL) amyloidosis.\n* Has received radiotherapy within 2 weeks of the first dose of BI-1206.\n* Has not recovered from AEs to at least Grade 1 by CTCAE v5.0 (or higher) due to prior anticancer therapies• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n* Has an active, known or suspected autoimmune disease.\n* Is a female subject and has the ability to become pregnant (or already pregnant or lactating\u002Fbreastfeeding)\n* Is a male subject with partner(s) of childbearing potential (unless he agrees to use a barrier method of contraception during the study and for 12 months after completing treatment)\n* Has had major surgery from which the subject has not yet recovered Is at high medical risk because of non-malignant systemic disease, including severe active infections on treatment with antibiotics, antifungals, or antivirals\n* Has presence of chronic graft-versus-host disease.\n* Has had an allogenic tissue\u002Fsolid organ transplant.\n* Has a known history of HIV infection\n* Has a history of active tuberculosis (Bacillus tuberculosis)\n* Has received a live vaccine within 30 days before the first dose of study treatment\n* Has uncontrolled or significant cardiovascular disease as listed in the main body of the protocol\n* Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or lead to participation not being in the best interest of the subject, in the opinion of the treating Investigator.\n* Is participating or planning to participate in another interventional clinical study or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study drug\n* Has a known additional malignancy of another type, with the exception of adequately treated cone-biopsied carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) and basal or squamous cell carcinoma of the skin\n* Has a diagnosis of primary or acquired immunodeficiency disorder or has taken any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Is unable to attend the study site to receive the study treatment\n\nAdditional exclusion criteria are described in the protocol.",{"count":161,"type":21},197,[58,97],"Phase 1\u002F2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors",[28],"2026-06-22",{"date":124,"type":39},{"date":168,"type":39},"2020-06-29",{"date":170,"type":21},"2027-11",{"name":172,"class":85},"BioInvent International AB",26,{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":184,"conditions":185,"keywords":196,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100564176","phase-1-open-label-study-of-bbo-10203-in-subjects-with-advanced-solid-tumors-100564176","NCT06625775","Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)","Inclusion Criteria:\n\n* Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive\u002FHER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC)\n* Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Adequate LVEF assessed by ECHO or MUGA (BBO-10203 + Trastuzumab cohorts only)\n* Stable brain metastases\n* Patients with HER2-positive aBC: Must have had at least 2 prior lines of anti-HER2-directed therapy. Only 1 prior line is acceptable where there is no other regionally available standard of care (SoC)\n* Monotherapy Cohort patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after at least one line of SOC treatment or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from SoC therapy\n* BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4\u002F6i\n* BBO-10203 + Fulvestrant + ribociclib combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, no prior systemic therapy in the aBC setting permitted\n* BBO-10203 + FOLFOX + Bevacizumab combination cohort patients with KRAS mutant aCRC: One prior line of irinotecan-containing therapy for locally advanced or metastatic CRC is allowed but not required\n\nExclusion Criteria:\n\n* Patients with KRAS mutant aCRC who have KRAS G12R mutation, BRAFV600E mutation, HER2amp, or dMMR\u002FMSI-H tumors\n* Patients with KRAS mutant aNSCLC who have KRAS G12R mutation, or tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1\u002FBRAF\u002FRET\u002FMET\u002FEGFR exon20 insertion\u002FNTRK\u002FHER2)\n* Patients with untreated and\u002For non-stable brain metastases\n\nOther inclusion\u002Fexclusion criteria are specified in the protocol",{"count":182,"type":21},392,[58],"First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.",[28,186,187,188,189,190,191,192,193,194,195],"Metastatic Breast Cancer","Advanced Breast Cancer","HER2 Mutation-Related Tumors","HER2-positive Metastatic Breast Cancer","KRAS Mutant Metastatic Colorectal Cancer","Metastatic Lung Cancer","Metastatic Colorectal Cancer","Advanced Lung Cancer","HR-positive, HER2-negative Advanced Breast Cancer","HER2-positive Advanced Breast Cancer",[197,198,199,200,201,202,203,204,205,206,71,207,208,209,210,211,212],"BREAKER-101","BridgeBio Oncology Therapeutics","BBOT","Phase1","Phase 1a\u002F1b","Trastuzumab","Breast","Colorectal","Non-Small Cell Lung Cancer","CRC","Metastatic Cancer","Advanced Cancer","HER2-positive","HR-positive","HR-positive, HER2-negative","HER2-negative","2026-06-18",{"date":145,"type":39},{"date":216,"type":39},"2024-10-29",{"date":218,"type":21},"2028-11",{"name":220,"class":85},"TheRas, Inc., d\u002Fb\u002Fa BBOT (BridgeBio Oncology Therapeutics)",40,{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":22,"phases":230,"briefSummary":231,"conditions":232,"keywords":244,"overallStatus":246,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":256},"100644129","phase-1-imaging-study-of-89zrdfo-ys5-for-cancer-detection-100644129","NCT07664397","Imaging Study of [89Zr]DFO-YS5 for Cancer Detection","A Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detection of Cancer in Patients With Various Malignancies","Inclusion Criteria:\n\n1. Histological or cytological confirmation of malignant peripheral nerve sheath tumor, bladder cancer, or solid tumor neoplasm.\n2. At least one soft tissue lesion measurable at 1 cm or greater in short axis measurement on cross sectional imaging such as Computerized tomography (CT), magnetic resonance imaging (MRI), or Positron Emission Tomography (PET)\u002FCT (scan imaging as documented in the medical record). Exception: For participants with localized bladder cancer (pre-cystectomy), lesions smaller than 1 centimeter (cm) are permitted, provided there is cystoscopic confirmation of a bladder mass.\n3. Clinically able to undergo PET-CT imaging or PET-MRI.\n4. Age ≥ 18 years.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky ≥ 50% (see Appendix 1).\n6. Adequate organ function as defined below:\n\n   * Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits).\n   * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)): ≤ 3 x ULN.\n   * Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)): ≤ 3 x ULN.\n   * Estimated creatinine clearance: ≥ 60 mL\u002Fmin, calculated using the Cockcroft-Gault equation.\n7. Females of reproductive potential (defined below) must be willing to undergo a urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours before administration of \\[89Zr\\]DFO-YS5. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries). The result of the urine or serum pregnancy test must be negative in order to initiate the \\[89Zr\\]DFO-YS5 administration. If a urine pregnancy test is positive or equivocal, a confirmatory a serum pregnancy test is required. The individual must be excluded from participation if the serum pregnancy result is positive. Pregnant individuals are excluded from this study because there is an unknown but potential risk for adverse effects in the unborn child secondary to treatment of the study participant with \\[89Zr\\]DFO-YS5.\n8. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.\n9. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Individuals with a contraindication to PET-CT imaging (e.g., severe claustrophobia) or PET-MRI (e.g., implanted devices, metallic objects, or other implants). Participants must be able to undergo either PET-CT or PET-MRI.\n2. Individuals who are pregnant or breastfeeding\u002Fchest-feeding. Pregnant and breastfeeding\u002Fchest-feeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn\u002Fnursing child secondary to treatment of the study participant with \\[89Zr\\]DFO-YS5. Females of childbearing potential must have a negative pregnancy test before administration of \\[89Zr\\]DFO-YS5, as outlined in inclusion criterion #7. Breastfeeding\u002Fchest-feeding should be discontinued before administration of \\[89Zr\\]DFO-YS5.\n3. Individuals who do not agree to follow the below contraception requirements:\n\n   Females of reproductive potential (defined below) must agree to use two forms of contraception, consisting of a barrier method (such as condoms) in combination with a secondary complementary method (such as hormonal, Intrauterine device (IUD), etc.), or strict abstinence, for the duration of study participation and for 1 month after administration of \\[89Zr\\]DFO-YS5. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries).\n4. Hypersensitivity to \\[89Zr\\]DFO-YS5 or any of its excipients.\n5. Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures.",{"count":221,"type":21},[58],"This is a single-center, pilot, PET-imaging study of the novel radiotracer 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody (\\[89Zr\\]DFO-YS5) in participants with nerve sheath tumor, bladder cancer, or advanced solid tumor neoplasms.",[233,234,235,236,237,238,239,240,241,242,28,243],"Bladder Cancer","Nerve Sheath Tumor","Nerve Sheath Tumors","Solid Tumor Malignancies","Solid Tumor Cancer","Solid Tumor Neoplasms","Advanced Solid Tumor","Bladder Neoplasm","Nerve Sheath Neoplasms","Nerve Sheath Tumor, Nos","Solid Carcinoma",[245],"Imaging Study","NOT_YET_RECRUITING","2026-06-17",{"date":249,"type":39},"2026-06-24",{"date":251,"type":21},"2026-08-01",{"date":253,"type":21},"2029-09-30",{"name":255,"class":45},"Robert Flavell, MD, PhD",1,{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":22,"phases":267,"briefSummary":268,"conditions":269,"keywords":285,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":309},"100520064","phase-1-a-study-to-evaluate-the-safety-and-efficacy-of-mesothelin-targeting-logic-gated-car-t-in-participants-with-solid-tumors-that-express-msln-and-have-lost-hla-a02-expression-100520064","NCT06051695","A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression","A Seamless Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Autologous Logic-gated Tmod™ CAR T Products, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression","EVEREST-2","Inclusion Criteria:\n\nKey Inclusion Criteria:\n\n1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\\*02 by NGS (whenever possible from the primary site), successful apheresis and PBMC processing, and with sufficient stored cells available for Tmod CAR T-cell therapy\n2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, OVCA, MESO, or other solid tumors with MSLN expression. Measurable disease is required with lesions of ≥1.0 cm by CT.\n3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol\n4. Has adequate organ function as described in the protocol\n5. ECOG performance status of 0 to 1\n6. Life expectancy of ≥3 months\n7. Willing to comply with study schedule of assessments including long term safety follow up\n\nKey Exclusion Criteria:\n\n1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative\n2. Prior allogeneic stem cell transplant\n3. Prior solid organ transplant\n4. MESO with pleural involvement extending into the peritoneum\n5. Cancer therapy within 3 weeks or 3 half lives of infusion\n6. Radiotherapy within 28 days of infusion\n7. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months\n8. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated\n9. History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year\n10. Requires supplemental home oxygen\n11. Females of childbearing potential who are pregnant or breastfeeding\n12. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion",{"count":266,"type":21},474,[58,97],"The goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\\*02 expression.\n\nThe main questions this study aims to answer are:\n\nPhase 1: What is the recommended dose that is safe for patients\n\nPhase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells\n\nParticipants will be required to perform study procedures and assessments, and will also receive the following study treatments:\n\nEnrollment and Apheresis in BASECAMP-1 (NCT04981119)\n\nPreconditioning Lymphodepletion (PCLD) Regimen\n\nTmod CAR T cells at the assigned dose",[28,72,71,270,271,272,273,274,275,206,276,277,102,278,279,280,281,282,283,284],"Non Small Cell Lung Cancer","NSCLC, Recurrent","Non-Small Cell Squamous Lung Cancer","Pancreas Cancer","Pancreatic Neoplasm","Colorectal Adenocarcinoma","Colon Cancer","Rectal Cancer","Ovarian Cancer","Ovarian Neoplasms","Mesothelioma","Mesothelioma, Malignant","Ovary Cancer","Lung Cancer","MESOM",[286,287,69,288,289,290,291,292,293,294,295,296,102,297,206,72,283,71,298,284,278,280,299],"CAR T Cell","Solid Tumors","T Cell","Mesothelin","MSLN","HLA-A2","Solid Tumors expressing MSLN","Pancreatic","Cell Therapy","Gene Therapy","blocker","PANC","OVCA","Logic-gate","2026-06-10",{"date":302,"type":39},"2026-06-12",{"date":304,"type":39},"2024-04-03",{"date":306,"type":21},"2029-06",{"name":308,"class":85},"A2 Biotherapeutics Inc.",12,{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":22,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":331},"100558720","phase-1-first-in-human-study-of-db-1419-for-advancedmetastatic-solid-tumors-100558720","NCT06554795","First-in-human Study of DB-1419 for Advanced\u002FMetastatic Solid Tumors","A Phase 1\u002F2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1419 in Participants With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Adults aged ≥ 18 years at the time of voluntarily signing informed consent.\n2. Histologically or cytologically confirmed unresectable advanced\u002Fmetastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or refused the standard treatment, or for which no standard treatment is available.\n3. At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria (Only applicable to backfill participants in phase 1a and participants in phase 1b\u002F2a). CRPC participants with bone-only disease may be eligible on a case-by-case basis after discussion with the Medical Monitor.\n4. Has a life expectancy of ≥ 3 months.\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.\n6. Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.\n7. Has adequate organ function within 7 days prior to the first dose of study treatment.\n8. Has adequate treatment washout period prior to the first dose of study treatment.\n9. Is willing to provide pre-existing resected tumor samples when available or undergo fresh tumor biopsy if feasible for the measurement of B7-H3 level and other biomarkers if no contraindication.\n\n   Note: there is no minimum B7-H3 expression level mandatory for entry into the study.\n10. Is capable of comprehending study procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments.\n11. Male and female participants of reproductive\u002Fchildbearing potential must agree to avoid pregnancy during the study and for at least 4 months and 7 months after the last dose of study treatment, respectively.\n12. Male participants must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study treatment administration. Female participants must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study treatment administration.\n\nExclusion Criteria:\n\n1. Prior treatment with B7-H3 targeted therapy or prior treatment with ADC containing a topoisomerase I inhibitor payload.\n2. Has a medical history of symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] classes II-IV or serious cardiac arrhythmia requiring treatment.\n3. Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.\n4. Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \\> 470 millisecond (ms) in males and females based on a 12-lead electrocardiogram (ECG) in triplicate.\n5. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis which needs glucocorticoids and antibiotics) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.\n6. Has a history of underlying pulmonary disorder including, but not limited to, pulmonary emboli within 3 months of the start of study treatment, severe asthma, severe COPD, restrictive lung disease, and other clinically significant pulmonary compromise or requirement for supplemental oxygen.\n7. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.\n8. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals within 2 weeks before first dose of study treatment.\n9. Know human immunodeficiency virus (HIV) infection.\n10. Has active viral hepatitis.\n11. Is a lactating mother, or pregnant as confirmed by pregnancy tests performed within 7 days prior to enrollment.\n12. Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with asymptomatic CNS metastases who are radiologically and neurologically stable for at least 4 weeks following CNS-directed therapy, and are on stable or decreasing doses of corticosteroids equivalent to ≤10 mg\u002Fday prednisone are eligible for study entry.\n13. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v 5.0, Grade ≤ 1 or baseline.\n14. Has a prior history of immune-related adverse event that required permanent immune checkpoint inhibitor discontinuation per NCCN guidelines.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":318,"type":21},360,[58,97],"A Phase 1\u002F2a First-in-Human Study of DB-1419 in Advanced\u002FMetastatic Solid Tumors",[28],"2026-06-04",{"date":324,"type":39},"2026-06-05",{"date":326,"type":39},"2024-09-03",{"date":328,"type":21},"2027-02",{"name":330,"class":85},"DualityBio Inc.",36,{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":342,"conditions":343,"keywords":354,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":373},"100586569","phase-1-bbo-11818-in-adult-subjects-with-kras-mutant-cancer-100586569","NCT06917079","BBO-11818 in Adult Subjects With KRAS Mutant Cancer","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers","Inclusion Criteria:\n\n* Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation\n* Measurable disease by RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Life expectancy \\>24 weeks\n* Adequate organ function\n\nExclusion Criteria:\n\n* Malignancy within the last 2 years as specified in the protocol\n* Untreated brain metastases\n\nOther inclusion\u002Fexclusion criteria are specified in the protocol.",{"count":340,"type":21},665,[58],"A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.",[205,71,344,345,346,347,348,349,65,350,351,352,353,28],"PDAC - Pancreatic Ductal Adenocarcinoma","CRC (Colorectal Cancer)","Metastatic Non-Small Lung Cell Cancer","Metastatic Colorectal Cancer (CRC)","KRAS G12A","KRAS G12C","KRAS G12S","KRAS G12V","Metastatic Pancreatic Ductal Adenocarcinoma","Advanced Lung Carcinoma",[199,198,200,201,71,206,70,207,208,355,356,357,358,359,360,361,362,363,364],"Pembrolizumab","Cetuximab","Platinum Chemotherapy","Pemetrexed","KONQUER","KONQUER-101","mFOLFOX6","mFOLFIRINOX","Gemcitabine","Nab-paclitaxel","2026-05-29",{"date":367,"type":39},"2026-06-02",{"date":369,"type":39},"2025-03-31",{"date":371,"type":21},"2029-09",{"name":220,"class":85},17,{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":384,"phases":4,"briefSummary":385,"conditions":386,"keywords":393,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":399,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":405},"100437810","solid-tumor-analysis-for-hla-loss-of-heterozygosity-loh-and-apheresis-for-car-t--cell-manufacturing-100437810","NCT04981119","Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing","An Observational Study Obtaining Solid Tumor Tissue From Participants and Apheresis for CAR T-Cell Therapy Manufacturing","BASECAMP-1","Key Eligibility Criteria (additional criteria may apply) Part 1 Key Inclusion Criteria\n\n1\\. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), or Pancreatic Cancer (PANC), that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years.\n\nPart 1: Key Exclusion Criteria\n\n1. History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.\n2. Prior allogeneic stem cell transplant.\n3. Prior solid organ transplant.\n\nPart 2 : Key Inclusion Criteria\n\n1. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer (PANC), Mesothelioma, or Ovarian Cancer (OVAC) that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years.\n2. Participants are germline HLA-A\\*02 heterozygous confirmed by HLA typing.\n3. Primary tumor tissue showing LOH of HLA-A\\*02 by NGS testing.\n4. Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status.\n\nPart 2: Key Exclusion Criteria\n\n1. History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.\n2. Prior allogeneic stem cell transplant.\n3. Prior solid organ transplant.\n4. Participants who have received any cancer therapy on any investigational therapy for any indication, including but not limited to chemotherapy, small molecules, monoclonal antibodies, or radiotherapy (with bone marrow impact) within 2 weeks of planned apheresis or 3 half-lives, whichever is shorter.\n5. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment necessitating specific treatment, or any major episode of infection requiring treatment with Intravenous (IV) antimicrobials (e.g., IV antibiotics) or hospitalization (relating to completion of antibiotic course).\n6. Has known active central nervous system metastases. Subjects with previously treated brain metastases may participate upon medical monitor agreement.\n7. In the Investigator's judgement, any other condition or reason the subject would not complete the required study visits and procedures, and follow up visits, or comply with the study requirements for participation.",{"count":383,"type":21},200,"OBSERVATIONAL","Objective:\n\nTo collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment.\n\nDesign:\n\nThis is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.",[28,72,270,387,206,71,273,280,278,279,388,281,389,102,390,391,392],"Pancreatic Cancer","Ovarian Carcinoma","Mesothelioma; Lung","Triple Negative Breast Cancer (TNBC)","Renal Cell Carcinoma (Kidney Cancer)","Head and Neck Squamous Cell Carcinoma HNSCC",[394,395,396,397,398],"CAR T Cell Therapy","Next Generation Sequencing","Leukapheresis","Apheresis","Immunotherapy",{"date":367,"type":39},{"date":401,"type":39},"2021-10-29",{"date":403,"type":21},"2029-04",{"name":308,"class":85},16,{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":415,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":440,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":256},"100348926","intravital-microscopy-in-human-solid-tumors-100348926","NCT03823144","Intravital Microscopy in Human Solid Tumors","Intravital Microscopy (IVM) in Human Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Eastern Cooperative Oncology Group (ECOG)Performance Status of ≤ 2\n* Measurable tumor by direct visualization requiring surgical resection in the operating room (OR)\n* Tumor types of origin include gastric, pancreatic, hepatobiliary, colorectal, sarcoma, brain, or breast cancer that may involve the axillary lymph nodes cancers. Tumors may be primary or metastatic\n* Subject must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent\n* Subject must have a skin prick test pre-operatively (at the time of the preoperative visit and after signed informed consent for entry into this clinical trial is given) to determine any sensitivity to fluorescein\n\nExclusion Criteria:\n\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations\n* Renal dysfunction as defined as a glomerular filtration rate (GFR) \\\u003C 45\n* Liver dysfunction as defined by Child-Pugh score \\> 5, or liver function test (LFT)'s 1.5 x above normal range\n* Any known allergy or prior reaction to fluorescein or a positive skin prick test to fluorescein\n* Pregnant or nursing female subjects, determined preoperatively with a urine pregnancy test\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigators' opinion deems the patient unsuitable (e.g., abnormal electrocardiography \\[EKG\\], including T wave inversion, elevated T waves, prolonged QRS interval, or conduction blocks) or that requires further work-up (including cardiac echo or stress test)\n* Any condition that excludes surgical resection as the standard of care for the patient",{"count":414,"type":21},85,[24],"This study will investigate the tumor-associated vasculature of patients with solid tumors. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the vessels associated with solid tumors. The IVM observations may determine if an individual patient's tumor vessels would be amenable to receiving systemic therapy, based on the functionality of the vessels.",[28,418,419,420,421,422,423,424,425,426,427,428,429,430,431,432,433,434,435,436,437,438,439],"Clinical Stage IV Gastric Cancer AJCC v8","Malignant Solid Neoplasm","Metastatic Colorectal Carcinoma","Metastatic Gastric Carcinoma","Metastatic Primary Malignant Brain Neoplasm","Metastatic Sarcoma","Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8","Resectable Colorectal Carcinoma","Resectable Liver and Intrahepatic Bile Duct Carcinoma","Resectable Pancreatic Carcinoma","Resectable Sarcoma","Stage IV Colorectal Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Malignant Brain Neoplasm","Metastatic Breast Carcinoma","Metastatic Liver Carcinoma","Metastatic Pancreatic Carcinoma","Resectable Brain Neoplasm","Resectable Breast Carcinoma","Resectable Gastric Carcinoma","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IV Pancreatic Cancer AJCC v8",{"date":367,"type":39},{"date":442,"type":39},"2019-02-28",{"date":444,"type":21},"2027-09-30",{"name":446,"class":45},"Mayo Clinic",{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":22,"phases":456,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":256},"100562041","phase-1-a-study-to-determine-the-effect-of-ct3001-in-patients-with-advanced-solid-tumors-100562041","NCT06598007","A Study to Determine the Effect of CT3001 in Patients With Advanced Solid Tumors","A Phase 1\u002F2 First-In-Human, Open-Label, Multicenter, Dose Escalation and Dose Expansion Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CT3001 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures.\n* Aged ≥ 18 years (or adult age as per local regulations).\n* Histologically\u002Fcytologically confirmed, locally advanced unresectable or metastatic solid tumors that are refractory to standard therapy, or for whom no standard therapy exists. Note: In Phase 2b, only participants with advanced CRC who are eligible for re-engaging FOLFOX will be enrolled.\n* Has measurable disease per RECIST Version 1.1. that was not in a prior radiation or other locally treated area unless imaging-based progression has been clearly documented following radiation or other local therapy.\n* Life expectancy ≥ 3 months, in the opinion of the PI or designee.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic, liver, and kidney function as follows:\n\nBone marrow reserve:\n\n1. Absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL without growth factor support in the 2 weeks prior to study entry.\n2. Hemoglobin ≥9.0 g\u002FdL without transfusion, growth factor support, or other supportive medication in the 2 weeks prior to study entry.\n3. Platelet count ≥ 75 × 10\\^9\u002FL without transfusion in 2 weeks prior to study entry.\n\nHepatic function:\n\n1. Serum TBIL \\\u003C 1.5 × ULN.\n2. AST and ALT \\\u003C 3 × ULN.\n\nRenal function:\n\nSerum creatinine clearance (CrCL) \\> 60 mL\u002Fmin, as per the Cockcroft-Gault Equation:\n\nCGGFR = \\[(140 - age in years) × weight in kg\\] \u002F (7.2 × serum creatinine in mg\u002FdL) (× 0.85 for females) (for urine protein \\\u003C 2+; if urine protein \\> 2+, 24-hour urinary protein quantity should be measured and must be \\\u003C 1.0 g).\n\n* Coagulation tests: international normalized ratio (INR) \\\u003C 1.5, activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (Note: for those on oral anticoagulants, an INR in the range of 2 to 3 is acceptable).\n* Participants (both males and females) of childbearing potential should be willing to use a viable contraception method that is deemed effective by the PI or designee from Screening, during the study, and for at least 3 months following the last dose of IP. Postmenopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential; postmenopausal status, if not known, is to be confirmed through testing of follicle-stimulating hormone (FSH) levels of ≥ 40 IU\u002FL. Male participants must be willing not to donate sperm until 3 months following the last IP administration.\n\nExclusion Criteria:\n\n* During Phase 1 Dose Escalation, receiving concurrent anticancer treatment (including chemotherapy, targeted drugs, radiotherapy \\[excluding the following small-area radiotherapy for bone metastasis\\], endocrine therapy, antitumor traditional Chinese Medicine), except during Phase 2b, Standard Care Chemotherapy (FOLFOX-based regimen) for advanced CRC patients is allowed.\n* Use of other IP within 5 half-lives of the product (if the IP is a small molecule) or anti-cancer investigational medical device within two weeks prior to the first administration of CT3001. Prior use of investigational monoclonal antibody IP can be permitted upon obtaining an approval from the Sponsor. Use of these investigational IP or devices are not permitted for the duration of treatment with CT3001.\n* Evidence of severe or uncontrolled systemic diseases, infection, or laboratory finding that in the view of the PI or designee makes it undesirable for the patient to participate in the trial.\n* Females who are pregnant or nursing, or any participant who is planning to become pregnant (self or partner) at any time during the study, including the Follow-up Period.\n* Has had major surgery or significant traumatic injury within 4 weeks of start of CT3001; participants have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or participant might require major surgery during the course of the study.\n* Has a prolonged QT interval corrected by Fredericia's formula (QTcF interval) of \\> 470 ms (determined by average of 3 readings on triplicate 12-lead ECG) or has a history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of long-QT syndrome) or current use of medications that prolong the QTcF interval.\n* Any psychiatric, psychological, familial or geographical condition that, in the judgment of the PI or designee, may interfere with the treatment and follow-up, affect compliance or place the participant at high risk of treatment-related complications will be excluded.\n* Blood donation or significant blood loss within 60 days prior to the first administration of CT3001.\n* History of severe allergic or anaphylactic reactions, or sensitivity to the CT3001 or its constituents.\n* Vaccination with a live vaccine within 4 weeks prior to the first administration of CT3001.\n* Exposure to any significantly immune suppressing drug (including experimental therapies as part of a clinical study) within 5 half-lives of the product prior to the first administration of CT3001; these medications will not be permitted for the duration of treatment with CT3001.\n* Use of any medications with a narrow therapeutics index that are sensitive substrates of and metabolized mainly through CYP2C8 within 5-half-lives of the products prior to the first administration of CT3001; these medications will not be permitted for the duration of treatment with CT3001.\n* Use of any gastric acid reducing agents during the time period between 6 hours prior to and 2 hours after the administration of CT3001.\n* Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibodies (HIV-1\u002F-2) at Screening, unless the participant meets 1 of the following criteria:\n\n  1. Has chronic hepatitis B virus (HBV) infection or virologically suppressed (VS) HBV AND has been on suppressive antiviral therapy (unless it is a prohibited medication per exclusion criteria #12) for at least 4 weeks.\n  2. Has chronic HCV infection but has completed curative antiviral treatment (note: patients may be HCV antibody positive but must be HCV RNA negative to be eligible).\n\nPlease note: the eligibility of patients with HBV or HCV infection should be considered on a case-by-case basis by the PI in consultation with the independent Medical Monitor.\n\n* Anything that the PI considers would jeopardize the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.",{"count":455,"type":21},78,[58,97],"This is an FIH, multicenter, open-label, dose escalation and dose expansion\u002Fdose optimization study of CT3001, which will be conducted in 2 phases: Phase 1 and Phase 2b. Phase 1 will be a standard 3+3 dose escalation and dose finding study in patients with advanced solid tumors for whom there is no available therapy (or patients are not candidates for such therapy) for the assessment of DLTs at up to 7 dose levels of CT3001. Phase 2b is a dose finding\u002Fdose optimization study of CT3001 in combination with SOC chemotherapy (FOLFOX) to evaluate the safety and preliminary efficacy of CT3001 in patients with advanced CRC who are eligible for re-engaging FOLFOX-based chemotherapy.",[28,72,63],"2026-05-27",{"date":365,"type":39},{"date":462,"type":39},"2024-09-20",{"date":464,"type":21},"2027-06-30",{"name":466,"class":85},"Crossignal Therapeutics, Inc.",{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":475,"targetDuration":4,"studyType":22,"phases":477,"briefSummary":478,"conditions":479,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":489},"100591231","phase-1-a-study-of-attr-01-in-participants-with-select-epithelial-solid-tumours-100591231","NCT06977737","A Study of ATTR-01 in Participants With Select Epithelial Solid Tumours","A Phase 1-2 Master Protocol to Study Intravenous ATTR-01 in Adult Participants With Select Epithelial Solid Tumours Under Multiple Sub-protocols","ATTEST","Inclusion Criteria:\n\n* Consenting male and female adults (18 years of age) with select solid epithelial tumour indications known to have high frequency (75 percent) of αvβ6 integrin receptor expression as detailed in the applicable SP.\n* Received and failed\u002Fintolerant of Standard of Care (SoC) therapy where eligible (not including neoadjuvant).\n* Tumour lesion (not previously irradiated), suitable for safe pre- and post-treatment biopsies.\n* Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.\n* Minimum life expectancy anticipated to be greater than three months\n* Willing to undertake appropriate measures of hygiene to prevent any spread of virus and protection of vulnerable individuals.\n* Adequate organ function.\n* Compliant with requirements for prior treatment washout and contraceptive measures applicable to genetically modified organisms (GMOs) and cancer therapies\n* Prior immune checkpoint antibody therapies as single agents or in combination with other anti-cancer agents is permissible.\n\nExclusion Criteria:\n\n* Significant degree of fibrotic disease, including autoimmune diseases (e.g. systemic lupus, rheumatoid arthritis) or idiopathic and occupation-related pulmonary fibrosis.\n* Known prior history of intolerance to anti-programmed cell death protein 1 (PD-1) and\u002For anti-PD-L1 immunotherapy due to toxicity.\n* Has any of the comorbid conditions listed in the detailed protocol exclusion criteria.",{"count":476,"type":21},72,[58,97],"ATTR-01 is the experimental drug being studied in the ATTEST clinical trial. The drug is made from a common cold virus that has been changed to only infect and multiply in cancer cells. This virus delivers an immune therapy drug into the cancer that is intended to promote a participant's own immune system to attack the cancer. The first part of this trial (sub-protocol A) is a phase 1 trial including dose escalation and expansion at one or more doses. It is the first time that ATTR-01 will be given to humans. If an optimal dose is identified, additional sub-protocols will be added by to further elicit whether ATTR-01 may successfully treat cancer. Expanded access is not available.",[28],"2026-05-21",{"date":482,"type":39},"2026-05-22",{"date":484,"type":39},"2025-03-21",{"date":486,"type":21},"2034-12-31",{"name":488,"class":85},"Accession Therapeutics Limited",8,{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":496,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":22,"phases":500,"briefSummary":501,"conditions":502,"keywords":503,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":520},"100338413","phase-1-actengine-ima203ima203cd8-as-monotherapy-or-in-combination-with-nivolumab-in-recurrent-andor-refractory-solid-tumors-100338413","NCT03686124","ACTengine® IMA203\u002FIMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and\u002For Refractory Solid Tumors","Phase 1\u002F2 Study Evaluating Genetically Modified Autologous T Cells Expressing a TCR Recognizing a Cancer\u002FGermline Antigen as Monotherapy or in Combination With Nivolumab in Patients With Recurrent and\u002For Refractory Solid Tumors","ACTengine","Inclusion Criteria:\n\n* Patients must have recurrent\u002Fprogressing and\u002For refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* HLA-A\\*02:01 positive\n* For patients with ovarian\u002Ffallopian tube cancer only: Patients must have confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.\n* For patients with endometrial carcinoma only: Patients must have a histologically confirmed diagnosis of recurrent or persistent endometrial carcinoma.\n* Measurable disease according to RECIST 1.1\n* Adequate selected organ function per protocol\n* Patient's tumor must express tumor antigen by \"IMADetect® RT-qPCR. Retrospective testing will be required for patients that qualify.\n* Life expectancy more than 5 months\n* Female patient of childbearing potential must use adequate contraception prior to study entry until 12 months after the infusion of IMA203\u002FIMA203CD8\n* Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203\u002FIMA203CD8\n* The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to lymphodepletion.\n\nExclusion Criteria:\n\n* History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years\n* Pregnant or breastfeeding\n* Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents.\n* History of cardiac conditions as per protocol\n* Prior stem cell transplantation or solid organ transplantation\n* Concurrent severe and\u002For uncontrolled medical disease that could compromise participation in the study\n* History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician\n* Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.\n* Patients with LDH greater than 2.0-fold ULN.\n* Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and\u002For IMA203\u002FIMA203CD8 treatment\n* Patients with active brain metastases\n* Concurrent treatment in another clinical trial.\n* For nivolumab treatment, patients must not have a history of severe immune-related toxicities, defined as any Grade 3 or 4 toxicities related to prior PD1\u002FPD-L1 inhibitor therapy (e.g., atezolizumab, pembrolizumab or nivolumab etc.).\n\nOther protocol defined inclusion\u002Fexclusion criteria could apply",{"count":499,"type":21},375,[58,97],"The study's purpose is to establish the safety and tolerability of IMA203\u002FIMA203CD8 products with or without combination with nivolumab in patients with solid tumors that express preferentially expressed antigen in melanoma (PRAME).",[100,101,28,102],[504,505,506,507,388,508,509,510],"T-cell therapy","immunotherapy","Melanoma (Skin)","Melanoma, Uveal","Uterine Carcinoma","Uterine Carcinosarcoma","Immatics","2026-05-12",{"date":513,"type":39},"2026-05-13",{"date":515,"type":39},"2019-05-14",{"date":517,"type":21},"2032-06",{"name":519,"class":85},"Immatics US, Inc.",21,{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":22,"phases":531,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":256},"100442041","phase-1-coast-therapy-in-advanced-solid-tumors-and-prostate-cancer-100442041","NCT05036226","COAST Therapy in Advanced Solid Tumors and Prostate Cancer","Combination of Autophagy Selective Therapeutics (COAST) in Advanced Solid Tumors or Relapsed Prostate Cancer, A Phase I\u002FII Trial","COAST","Inclusion Criteria:\n\n1. Patient must have advanced solid tumor cancer of any type (Phase I) or advanced prostate cancer (Phase II). Prostate cancer patients must have a PSA of at least 0.1 ng\u002FmL.\n2. Tissue diagnosis documented by pathology report, or clinic note attesting to same.\n3. Measurable \u002F evaluable tumor by RECIST, quantitative blood biomarker, or radionuclide imaging\n4. Voluntary, signed and dated, Institutional Review Board (IRB) approved consent form in accordance with regulatory and institutional guidelines.\n5. Documented progression of disease during treatment with one or more standard systemic regimens. Single or multiple regimens of chemotherapy, hormone suppression therapy, radiation therapy, surgery, immunotherapy, or adoptive cell therapy are allowed.\n6. 18 years of age or older.\n7. ECOG performance status of 0-2.\n8. Bilirubin ≤ 1.5 times upper limit of normal (ULN) and AST \u002F ALT ≤ 3 times ULN. Subjects with Gilbert's syndrome may be included if the total bilirubin is \\\u003C 3 times ULN and the direct bilirubin is within normal limits.\n9. Serum creatinine ≤ 1.5 times ULN.\n10. Absolute neutrophil count (ANC) ≥ 1,000 cells \u002F mm3\n11. Platelet count ≥ 75,000 cells \u002F mm3\n12. Hemoglobin ≥ 9 g\u002F dL.\n13. Fasting glucose ≤ 160 mg\u002FdL or non-fasting glucose ≤ 200 mg\u002FdL.\n14. Urinalysis with no clinically significant abnormalities.\n15. Adequately controlled blood pressure as determined by the treating investigator.\n16. Subjects with the potential to produce children must agree to effective contraceptive method use during study participation.\n17. Patients requiring narcotic analgesics must be on stable doses for at least 2 weeks prior to study entry.\n18. Patients being considered for a dose level containing nelfinavir mesylate must discontinue any statin use within 48 hours of beginning study treatment.\n\nExclusion Criteria:\n\n1. New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or history of ischemia on ECG.\n2. Underlying psychiatric disorder requiring hospitalization within the last two years.\n3. Clinically significant neurological disorder (Parkinson's disease, dementia, multiple sclerosis), as determined by the enrolling investigator.\n4. Active, uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy.\n5. Treatment with local or systemic radiation therapy, surgery, or investigational therapy within 28 days prior to registration.\n6. Unwillingness or inability to comply with procedures required in this protocol.\n7. Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator.\n8. Patients who are receiving, coumadin, apixaban, argatroban or rivaroxaban.\n9. Patients who are currently participating in any other clinical trial of an investigational product.\n10. Any other mental incapacitation or psychiatric illness that would preclude study participation, as determined by the enrolling investigator.\n11. Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.",{"count":530,"type":21},76,[58,97],"The purpose of this Phase I\u002FII study is to determine the safety and effectiveness of up to 5 study drugs used together for the treatment of solid tumor cancers. The drugs are hydroxychloroquine, metformin, sirolimus, dasatinib and nelfinavir and are given orally.",[534,28],"Prostate Cancer Recurrent","2026-05-11",{"date":513,"type":39},{"date":538,"type":39},"2022-03-03",{"date":540,"type":21},"2028-05-21",{"name":542,"class":45},"Medical University of South Carolina",{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":22,"phases":552,"briefSummary":553,"conditions":554,"keywords":558,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":574},"100375230","phase-2-study-of-induction-pd-1-blockade-in-subjects-with-locally-advanced-mismatch-repair-deficient-solid-tumors-100375230","NCT04165772","Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors","A Phase II Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors","Inclusion Criteria:\n\n* Willing and able to provide written informed consent for the trial.\n* Be ≥18 years of age on the date of signing informed consent.\n* ECOG performance status of 0 or 1.\n* Histologically confirmed locally advanced solid tumor (Cohorts 1 \\& 2)\n* Histologically confirmed endometrial cancer (Cohort 3)\n* Solid tumors that in standard practice would be treated with neoadjuvant therapy or surgery (depending on tumor type) (Cohorts 1 \\& 2)\n* Endometrial cancer that is clinically FIGO 2009 Stage I or II (Cohort 3).\n* No evidence of distant metastases.\n\n  * Radiologically measurable or clinically evaluable disease\n* Tumor specimen that demonstrates mismatch repair deficiency by Immunohistochemistry or microsatellite instability as demonstrated by NGS or PCR.\n* Negative pregnancy test done 72 hours prior to beginning treatment, for women of childbearing potential only. Subjects of childbearing potential must be willing to use an adequate method of contraception. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom). Contraception, for the course of the study starting with the first dose of study medication through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n\n  1. For Cohort 3, the use of a combination estrogen\u002Fprogesterone contraceptive is allowed; the use of progesterone-only methods including hormone (progestin) releasing IUD, depot medroxyprogesterone acetate, and progestin-only birth control pills is not allowed.\n\nNonchildbearing potential is defined as follows (by other than medical reasons):\n\n* ≥45 years of age and has not had menses for \\>1 year\n* Patients who have been amenorrhoeic for \\\u003C2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation\n* Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study.\n\n  * Participant receiving corticosteroids may continue if their dose is stable for least 4 weeks prior to initiating protocol therapy.\n  * Has QTcF ≤ 450 msec, or ≤ 480 msec for participants with bundle branch block.\n  * Demonstrate adequate organ function as defined below within 14 days of Cycle 1, Day 1, all screening labs should be performed within 14 days of treatment initiation.\n  * Hematological\n* Absolute neutrophil count (ANC) ≥1,500 \u002FmcL\n* Platelets ≥100,000 \u002F mcL\n* Hemoglobin \\>9 g\u002FdL or ≥5.6 mmol\u002FL\n\n  * Renal\n* Serum creatinine OR Measured or calculated(a) creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × upper limit of normal (ULN) OR ≥60 mL\u002Fmin for subject with creatinine levels \\> 1.5 × institutional ULN\n\n  * Hepatic\n* Serum total bilirubin ≤ 1.5 × ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN\n* AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN\n\n  * Coagulation\n* International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) ≤1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants ≤1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended (a) Creatinine clearance should be calculated per institutional standard.\n\nExclusion Criteria:\n\n* Presence of metastatic or recurrent disease\n* Prior radiation therapy, chemotherapy, or surgery for tumor\n\n  a. NOTE: For Cohort 3, patients are allowed to have received prior hormonal therapy for treatment of endometrial hyperplasia and\u002For endometrial cancer. Hormonal therapy must be discontinued at least 1-week prior to first dose of study treatment (dostarlimab).\n* For patients with colorectal primary -Tumor is causing symptomatic bowel obstruction (patients who have a temporary diverting ostomy are eligible).\n* Cohort 1 Only: Other invasive malignancy ≤ 5 years prior to registration. Exceptions are non-melanoma skin cancer that has undergone potentially curative therapy and in situ cervical carcinoma.\n* Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of non- physiologic dose immunosuppressive therapy within 7 days prior to first dose of trial treatment.\n* Active autoimmune disease requiring systemic treatment within the past 2 years or documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents at non-physiologic doses.\n* Active infection requiring systemic therapy.\n* Cohort 1 \\& 3: Received prior therapy with an antibody or drug specifically targeting T- cell co-stimulation or checkpoint pathways.\n* Experienced ≥ Grade 3 immune-related AE with prior immunotherapy, except for non-clinically significant lab abnormalities.\n* Other Anticancer or Experimental Therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide, anti-VEGF\u002FFlk-1 monoclonal antibody or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.\n* Known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies)\n* Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Women who are pregnant or breastfeeding, or men expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening visit through 150 days after the last dose of study medication.\n* Concurrent medical or psychiatric condition or disease which, in the investigator's judgement, would make them inappropriate candidates for entry into the study. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.\n* Received a live vaccine within 30 days of planned start of study medication.\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment.\n\n  a. NOTE: For Cohort 3: endometrial sampling (e.g., biopsies, dilatation and curettage), is NOT considered major surgical procedure.\n* History of interstitial lung disease.\n* Known hypersensitivity to TSR-042 components or excipients.",{"count":551,"type":21},212,[97],"The purpose of this study is to find out whether the study drug, TSR-042, followed by standard chemoradiotherapy (the chemotherapy drug capecitabine + radiation therapy) and standard surgery is an effective treatment for advanced dMMR solid tumors. The study will also look at the safety of the study drug.",[555,556,557,27,28],"Rectal Adenocarcinoma","Clinical Stage: Stage II (T3-4, N-)","Stage III (Any T, N+)",[559,560,561,562,563,564,565,566],"PD1 blockade","TSR-042","Radiation","Capecitabine","5-FU","19-288","Solid tumor","Dostarlimab","2026-05-08",{"date":513,"type":39},{"date":570,"type":39},"2019-12-11",{"date":572,"type":21},"2026-11-30",{"name":34,"class":45},10,{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":582,"targetDuration":584,"studyType":384,"phases":4,"briefSummary":585,"conditions":586,"keywords":589,"overallStatus":246,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":256},"100584924","ucsf-biobank-for-hereditary-cancers-and-tumor-associated-mutations-100584924","NCT06895681","UCSF Biobank for Hereditary Cancers and Tumor-Associated Mutations","UCSF Biobank for Studying Hereditary Cancers and Tumor-Associated Mutations","Inclusion Criteria:\n\nFor participants undergoing collection of tissue, ascites, and\u002For pleural effusions:\n\n1. Ability to understand and willingness to voluntarily sign a written informed consent document prior to any study-related assessments or procedures are conducted.\n2. Individuals 18 years of age or older on the day of signing informed consent.\n3. Individuals with solid tumor malignancy with germline or somatic cancer-associated mutations and\u002For Individuals with a family history or personal history of cancer.\n4. Must be planning to undergo one of the following procedures as part of their routine care (or as a research procedure under a UCSF-sponsored IIT protocol):\n\n   1. Surgical resection\n   2. Biopsy (open, incisional, excisional, punch, core needle, and\u002For fine needle aspiration (FNA) are all permitted)\n   3. Paracentesis\n   4. Thoracentesis\n\nFor participants undergoing blood banking:\n\n1. Ability to understand and willingness to voluntarily sign a written informed consent document prior to any study-related assessments or procedures are conducted.\n2. Individuals 18 years of age or older on the day of signing informed consent.\n3. Individuals with a family history or personal history of cancer.\n4. Must be planning to undergo a blood draw as part of their routine care (or as a research procedure under a University of California, San Francisco (UCSF) -sponsored investigator-initiated trial (IIT) protocol); or willing to undergo an additional blood draw outside of their routine care.\n\nExclusion Criteria:\n\n1\\. Known history of HIV, Hepatitis B, or Hepatitis C (as documented in the medical record) or other infectious disease that in the judgment of the investigator could pose a risk to research personnel or mice, or negatively impact Patient derived xenografts (PDX) tumor engraftment.",{"count":583,"type":21},50000,"10 Years","This is a non-therapeutic clinical research biorepository protocol designed to obtain, store, and clinically annotate biospecimens from participants with hereditary cancers. Those biospecimens will be used to generate participant-derived tumor models that will serve as a resource to better understand hereditary cancers and develop new efficient therapies.",[27,28,587,29,588],"Somatic Mutation","Hereditary Cancer",[590,591],"Germline Mutations","Tumor-Associated Mutations","2026-04-28",{"date":594,"type":39},"2026-05-04",{"date":596,"type":21},"2026-08-31",{"date":598,"type":21},"2035-12-31",{"name":600,"class":45},"University of California, San Francisco",{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":608,"enrollmentInfo":609,"targetDuration":4,"studyType":22,"phases":610,"briefSummary":611,"conditions":612,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":132},"100527200","phase-1-gt201-injection-for-the-treatment-of-advanced-solid-tumors-100527200","NCT06144671","GT201 Injection For The Treatment Of Advanced Solid Tumors","A Single-Arm Phase I\u002FII Clinical Study of Autologous Tumor-Infiltrating Lymphocyte Injection (GT201) for The Treatment Of Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board\u002FIndependent Ethics Committee (IRB\u002FIEC), must have the ability to understand the requirements of the study;\n* 2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies;\n* 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues ≥1.0cm\\^3 (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible.\n\nExclusion Criteria:\n\n* 1.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\\>10 mg\u002Fday of prednisone or equivalent hormone);\n* 2\\. Arterial\u002Fvenous thrombotic events within 3 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;\n* 3\\. Patients who have refractory or intractable epilepsy, poorly controlled hydrothorax, hydrops abdominis, pericardial effusion or IL-2 contraindications;\n* 4\\. Participate in other clinical trials within 4 weeks prior to the first dose of this study, or planning to participate in this study and other clinical trials at the same;\n* 5\\. Patients who have received allogeneic bone marrow transplantation or an organ allograft;\n* 6.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin).","70 Years",{"count":86,"type":21},[58,97],"Expected to complete 7 to 18 evaluable subjects (patients with advanced solid tumors)，3 dose groups.A modified \"3+3\" dose-escalation design is utilized,This includes both accelerated dose escalation and traditional \"3+3\" dose escalation.The first dose group is accelerated titration,The first dose group is an accelerated titration of 1 to 6 evaluable subjects;The second and third dose groups are based on the traditional \"3+3\" dose-escalation principle,The second and third dose groups are based on the traditional \"3+3\" dose-escalation principle, with 3 to 6 evaluable subjects enrolled respectively.",[28],"2026-04-22",{"date":615,"type":39},"2026-04-27",{"date":617,"type":39},"2023-09-13",{"date":619,"type":21},"2026-09-13",{"name":621,"class":85},"Grit Biotechnology",{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":4,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":629,"targetDuration":4,"studyType":22,"phases":631,"briefSummary":632,"conditions":633,"keywords":635,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":650},"100594498","phase-1-a-phase-12-study-of-vs-7375-in-patients-with-kras-g12d-mutated-solid-tumors-100594498","NCT07020221","A Phase 1\u002F2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors","A Phase 1\u002F2, Open-label Study of VS-7375, a KRAS G12D (ON\u002FOFF) Inhibitor, as Monotherapy and in Combination, in Patients With Advanced KRAS G12D-Mutated Solid Tumors","Key Inclusion Criteria:\n\n* Individuals ≥18 years of age.\n* Agreement to sign and date an informed consent form (ICF) approved by the Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC).\n* Histologic or cytologic evidence of locally advanced unresectable or metastatic solid tumor harboring a KRAS G12D mutation.\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Adequate organ function\n* Adequate cardiac function\n* Recovered from all AEs due to previous therapies to Grade ≤1 or baseline.\n* Agreement to use highly effective contraception\n\nKey Exclusion Criteria:\n\n* Underwent major surgical procedure as defined by the Investigator, other than for diagnosis, within 4 weeks prior to Cycle 1 Day 1,\n* Receipt of chemotherapy, targeted therapy, or radiotherapy (excluding palliative radiation) within 4 weeks or 5 half-lives, whichever is shorter, or immunotherapy within 4 weeks prior to Cycle 1 Day 1\n* Treatment with any investigational drug at least 4 weeks or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1.\n* History of treatment with direct and specific KRAS G12D inhibitors.\n* Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases.\n* Inability to swallow oral medications.\n* Evidence or history of uncontrolled, clinically significant hematological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, coagulation, neurologic, dermatologic, autoimmune, or allergic disease\n* Individuals who are pregnant or breastfeeding.",{"count":630,"type":21},295,[58,97],"This study will assess the safety and efficacy of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.",[63,270,72,28,634],"G12D Mutated KRAS",[636,73,270,283,72,207,387,63,71,206,70,637,638,639,640,68,641],"KRAS G12D mutation","Pancreatic Neoplasms","Colorectal Neoplasms","Lung Neoplasms","Gastrointestinal Neoplasms","RAS","2026-04-21",{"date":613,"type":39},{"date":645,"type":39},"2025-06-24",{"date":647,"type":21},"2028-12",{"name":649,"class":85},"Verastem, Inc.",14,{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":4,"eligibilityCriteria":657,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":658,"targetDuration":4,"studyType":22,"phases":660,"briefSummary":661,"conditions":662,"keywords":684,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":691,"lastUpdatePostDateStruct":692,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":697,"locationsCount":699},"100561192","phase-1-a-study-with-nkt3964-for-adults-with-advancedmetastatic-solid-tumors-100561192","NCT06586957","A Study With NKT3964 for Adults With Advanced\u002FMetastatic Solid Tumors","A Phase 1, First-in-human, Open-label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral CDK2 Degrader NKT3964 in Adults With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n\\- Must have a pathologically confirmed advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. Part 1 only: subjects must be refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.\n\nDose Escalation:\n\n1. Ovarian cancer\n2. Endometrial cancer (only endometrioid subtype will require CCNE1 amplification)\n3. Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification\n4. Small cell lung cancer (SCLC)\n5. Triple-negative breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative)\n6. HR+ (includes estrogen-receptor or progesterone-receptor) and HER2- breast cancer (must have progressed following treatment with a CDK4\u002F6 inhibitor, and is not suitable for endocrine therapy \\[ET\\])\n7. Other solid tumors with CCNE1 amplification\n\nDose Expansion:\n\nPart 2A: HR+ and HER2- breast cancer that is locally advanced and unresectable (Stage III) or metastatic (Stage IV); previously treated with ≥1 line of standard of care (SOC) including CDK4\u002F6 inhibitor plus ET and not suitable for further ET. Subjects must have progressed after receiving therapy for ≥3 months in the metastatic setting or for ≥6 months in the adjuvant setting. Subjects must have received ≤2 lines of systemic cytotoxic therapy (chemotherapy or cytotoxic antibody drug conjugate \\[ADC\\]) in the metastatic setting..\n\nPart 2B: Advanced platinum-based-chemotherapy resistant or refractory epithelial ovarian\u002Ffallopian\u002Fprimary peritoneal carcinoma or clear cell ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least one platinum containing therapy and previously treated with ≤4 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease and with CCNE1 amplification.\n\nPart 2C: Advanced unresectable or metastatic gastric, GEJ or esophageal adenocarcinoma with progression on at least one systemic therapy and previously treated with ≤3 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease, with CCNE1 amplification as determined by NGS by local liquid or tissue test.\n\nPart 2D: Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease with CCNE1 amplification.\n\nPart 2E: Advanced\u002Frecurrent uterine carcinosarcoma previously treated with 1 prior platinum-based chemotherapy regimen and ≤3 prior lines of systemic therapy. Prior bevacizumab or PARP inhibitors are allowed and must be at least 3 weeks prior to the start of study drug.\n\n* Have adequate organ function\n* Subjects with female reproductive organs must be surgically sterile, post-menopausal, or must be willing to use highly effective method(s) of contraception\n* Ability to swallow oral medications.\n* Consent to provide archived tumor tissues and paired tumor biopsy at pretreatment\n\nExclusion Criteria:\n\n* Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and\u002For radiotherapy, or chemotherapy.\n* History of another malignancy with exceptions\n* History of lymphohistiocytic or lymphoid hyperplasia; hemophagocytic lymphohistiocytosis.\n* Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)\n* Clinically significant cardiovascular event within 6 months prior to start of NKT3964 treatment\n* Known active CNS metastases and\u002For carcinomatous meningitis\n* Active interstitial lung disease currently requiring treatment\n* History of uveitis, retinopathy or other clinically significant retinal disease\n* Active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease\n* Active wound healing from major surgery within 1 month or minor surgery within 10 days before the first dose of NKT3964.\n* Known human immunodeficiency virus (HIV), active hepatitis B or C infection\n* Prior investigative treatment with a selective or nonselective CDK2 inhibitor or degrader\n* Childs-Pugh class B or C cirrhosis or any other clinically significant liver disorder\n* Palliative radiation therapy within 14 days or other radiation therapy within 4 weeks prior to C1D1",{"count":659,"type":21},150,[58],"The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).",[27,239,28,663,278,279,388,664,665,666,667,668,669,670,671,672,673,674,421,675,676,677,678,679,680,681,682,683],"Metastatic Tumor","Metastatic Ovarian Carcinoma","Endometrial Neoplasms","Endometrial Diseases","Metastatic Endometrial Cancer","Triple Negative Breast Cancer","Metastatic Endometrial Carcinoma","Advanced Endometrial Carcinoma","Advanced Ovarian Carcinoma","Gastric Cancer","Advanced Gastric Carcinoma","Metastatic Gastric Cancer","Small Cell Lung Cancer","Small Cell Lung Carcinoma","Triple Negative Breast Neoplasms","Platinum-resistant Ovarian Cancer","Platinum-refractory Ovarian Carcinoma","CCNE1 Amplification","Hormone Receptor Negative Breast Carcinoma","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","Progesterone-receptor-positive Breast Cancer",[685,686,687,688,689,690],"CDK 2 Inhibitor","CDK 4 Inhibitor","CDK 6 Inhibitor","CDK2 Degrader","Protein Degrader","PROTAC","2026-04-16",{"date":642,"type":39},{"date":694,"type":39},"2024-09-19",{"date":696,"type":21},"2029-05",{"name":698,"class":85},"NiKang Therapeutics, Inc.",19,{"id":701,"slug":702,"hasResults":12,"nctId":703,"briefTitle":704,"officialTitle":705,"acronym":706,"eligibilityCriteria":707,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":708,"targetDuration":4,"studyType":22,"phases":710,"briefSummary":711,"conditions":712,"keywords":720,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":724,"lastUpdatePostDateStruct":725,"startDateStruct":727,"completionDateStruct":729,"leadSponsor":731,"locationsCount":733},"100541173","phase-1-a-study-to-investigate-the-safety-and-efficacy-of-nst-628-oral-tablets-in-subjects-with-solid-tumors-100541173","NCT06326411","A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors","A Phase I, Open Label Single-arm Two-part Study to Investigate Safety, Pharmacokinetics, and Preliminary Efficacy of Pan-RAF\u002FMEK Glue NST-628 Oral Tablets in Subject With Solid Tumors Harboring Genetic Alterations in the MAPK Pathway and With Other Solid Tumors","NST-628","Inclusion Criteria:\n\nSubjects are eligible to be included in the study only if all of the following criteria apply:\n\n1. Subjects must be ≥18 years old (or of legal age of consent in the country in which the study is taking place) at the time of signing the informed consent.\n2. Subjects who have a histologically or cytologically documented metastatic or locally advanced solid tumor, for which standard of care (SoC) therapy does not exist, no longer provides benefit, or is not tolerated by the subject, or the subject has been assessed by the Investigator as not being suitable for SoC therapy.\n\n   1. Part A: Subjects with any solid tumor with genetic alteration of or evidence of tumor dependence upon the RAS\u002FMAPK pathway (subject to additional restrictions specified in the study protocol)\n   2. Part B: Subjects must be diagnosed with one of the following solid tumors harboring specified genetic alterations based on a validated local test:\n\n   i. Melanoma Cohorts:\n   1. Activating NRAS mutations\n   2. Select BRAF alterations\n\n   ii. Non-Melanoma Cohorts:\n   1. Solid tumors with NRAS activating mutations\n   2. Solid tumors with KRAS activating mutations\n   3. Solid tumors with select BRAF alterations\n   4. Glioma with BRAF alterations\n3. Newly obtained or archived tumor tissue is required\n4. Part B: measurable disease as defined by RECIST Version 1.1 or by other disease assessment tool standard for a given tumor type (if RECIST v. 1.1 is not standard)\n5. Performance status\n\n   1. Solid tumors other than glioma: ECOG 0 or 1\n   2. Glioma: Karnofsky ≥ 70 and ECOG 0 or 1\n6. Have adequate organ function\n7. Understand and voluntarily sign an Institutional Review Board\u002FIndependent Ethics Committee-approved informed consent form prior to any study-specific evaluation.\n8. Life expectancy ≥ 12 weeks\n\nExclusion Criteria:\n\nSubjects are excluded from the study if any of the following criteria apply:\n\n1. Conditions interfering with oral intake of NST-628\n2. Conditions interfering with intestinal absorption of an orally administered drug\n3. A history or current evidence of significant retinal pathology leading to increased risk of RVO\n4. A history or evidence of cardiovascular risk\n5. Current or history within 6 months of planned Cycle 1 Day 1 of pneumonitis or interstitial lung disease (ILD)\n6. Part B: prior treatment with any MEK or BRAF inhibitor\n7. Untreated or symptomatic central nervous system (CNS) metastases\n8. Chemotherapy, radiation, gene therapy, vaccine therapy, or anti-cancer antibodies \u002F ADCs within 28 days of Cycle 1 Day 1\n9. Targeted small molecule agents within 14 days or 5 half-lives of Cycle 1 Day 1\n10. Females who are pregnant or breastfeeding.\n11. For fertile patients (female able to become pregnant or male able to father a child), refusal to use effective contraception during the period of the trial and for 6 months after the last dose of NST-628\n12. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study",{"count":709,"type":21},230,[58],"This is a two-part Phase 1, open label, multi-center, single arm, non-randomized, multiple dose, safety, pharmacokinetic (PK) and preliminary efficacy study of single agent NST-628 in adult patients with MAPK pathway mutated\u002Fdependent advanced solid tumors who have exhausted standard treatment options.",[713,714,715,716,717,71,718,28,719],"Oncology","MEK Mutation","RAF Gene Mutation","Ras (KRAS or NRAS) Gene Mutation","Melanoma","Glioma","MAPK Pathway Gene Mutation",[641,721,722,723],"MEK","RAF","solid tumor","2026-04-15",{"date":726,"type":39},"2026-04-20",{"date":728,"type":39},"2024-04-09",{"date":730,"type":21},"2029-11",{"name":732,"class":85},"Nested Therapeutics, Inc",23,{"id":735,"slug":736,"hasResults":12,"nctId":737,"briefTitle":738,"officialTitle":739,"acronym":4,"eligibilityCriteria":740,"healthyVolunteers":12,"sex":17,"minAge":741,"maxAge":4,"enrollmentInfo":742,"targetDuration":4,"studyType":22,"phases":744,"briefSummary":745,"conditions":746,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":748,"lastUpdatePostDateStruct":749,"startDateStruct":751,"completionDateStruct":753,"leadSponsor":754,"locationsCount":756},"100331374","phase-1-a-study-of-hqp1351-in-patients-with-gist-or-other-solid-tumors-100331374","NCT03594422","A Study of HQP1351 in Patients With GIST or Other Solid Tumors","A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Oral HQP1351 in Patients With GIST or Other Solid Tumors.","Inclusion Criteria:\n\n1. Male or not pregnant or lactating women, age≥12years.\n2. Advanced and\u002For metastatic GIST or other solid tumors, confirmed by histology and\u002For cytology. GIST patients must be primary resistant to imatinib (tumor progresses within 6 months first-line imatinib treatment, or succinate dehydrogenase B (SDHB) deficient confirmed by immunohistochemistry, or NF1 mutation), OR imatinib or imatinib and at least one other TKI treatment failure (after imatinib or other TKI treatment for more than 6 months, tumor progress again after achieving tumor remission or stability).\n3. ECOG≤ 2.\n4. Estimated survival at least 3 months.\n5. Adequate hematologic and bone marrow functions.\n6. Adequate renal and liver function.\n7. Heart function index:\n\n   * Troponin(I\u002FT) ≤ Upper Limit of Normal;\n   * Ejection fraction \\>40%;\n   * QTc interval ≤ 450 ms in male or ≤ 470 ms in female.\n8. Negative serum pregnancy test (for women of childbearing potential) documented within the 24-hour prior to the first dose of investigational product.\n9. Willing to use contraception by a method that is deemed effective by the investigator by Subject and their partners throughout the treatment period and for at least 30 days following the last dose of study drug.\n10. Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the subject prior to any study-specific procedures).\n11. Willing and ability to comply with study procedures and follow-up examination.\n\nExclusion Criteria:\n\n1. Received any anti-cancer chemotherapy, biological agent treatment (e.g. Monoclonal antibody), immunotherapy (e.g. IFN) or radiotherapy with 28 days or 5 times half- time before first dose of HQP1351.\n2. Received any TKIs within 14 days before first dose of HQP1351.\n3. Attended any clinical trials on other drugs within 14 days before first dose of HQP1351.\n4. Have not recovered (\\> Grade 1 by CTCAE, v. 4.0) from AEs (except alopecia) due to agents previously administered.\n5. Malabsorption syndrome or other diseases that affect the absorption of oral drugs.\n6. Cardiovascular diseases of clinical significance, uncontrollable or active, including but not limited to: history of myocardial infarction; unstable history of angina pectoris; a history of congestive heart failure or lower left ventricular ejection fraction (LVEF) than normal limit within 6 months; the history of atrial arrhythmias was judged by the researchers to have important clinical significance; history of ventricular arrhythmias, etc.\n7. Hypertension was still poorly controlled after medication treatment (SBP \\> 140 mmHg and\u002For DBP \\> 90 mmHg).\n8. Concurrent use any medication led to prolong QT interval.\n9. Pulmonary mean arterial pressure\\>35 mmHg by ECHO.\n10. Significant severe cardiovascular conditions during previous TKI treatment.\n11. Uncontrollable hypertriglyceridemia.\n12. Performed major surgery (except for intravenous catheterization or bone marrow biopsy) within 14 days of first dose of HQP1351.\n13. Arterial thrombosis or embolism events such as cerebrovascular accident (including transient ischemic attack, TIA), or venous thrombosis events or pulmonary embolism within 6 months before the first dose of HQP1351 or deep vein thrombosis within 3 months before the first dose of HQP1351.\n14. Brain metastasis.\n15. Had other primary malignant tumors in the last three years (exception of the tumors being cured for 5 years or more, or complete removal of non-melanoma skin cancer or successful treatment of carcinoma in situ, or the controlled prostate cancer).\n16. Had active, symptomatic infections (including known infections of HIV, viral hepatitis (A, B, or C)). If there is no history of infection, screening is not required.\n17. Subjects who are known to be allergic to pharmaceutical ingredients or their analogs.\n18. Pregnancy or lactation, or expect to be pregnant during the study period.\n19. According to the judgment of the investigator or sponsor, any symptoms or disease of the subject may jeopardize the safety or safety assessment of the subject.\n20. Any other condition or circumstance of that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.","12 Years",{"count":743,"type":21},100,[58],"This study is a Multi-center, Open-label Phase 1 Study to Determine the Recommend Phase 2 Dose (RP2D) and Evaluate PK\u002FPD and preliminary Efficacy of HQP1351 in Patients With GIST or Other Solid Tumors.",[747,28],"Gastrointestinal Stromal Tumor (GIST)","2026-04-06",{"date":750,"type":39},"2026-04-09",{"date":752,"type":39},"2018-07-11",{"date":647,"type":21},{"name":755,"class":85},"Ascentage Pharma Group Inc.",6,{"id":758,"slug":759,"hasResults":12,"nctId":760,"briefTitle":761,"officialTitle":762,"acronym":763,"eligibilityCriteria":764,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":765,"targetDuration":4,"studyType":22,"phases":767,"briefSummary":768,"conditions":769,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":780,"lastUpdatePostDateStruct":781,"startDateStruct":783,"completionDateStruct":785,"leadSponsor":787,"locationsCount":152},"100550264","phase-1-a-study-of-vet3-tgi-in-patients-with-solid-tumors-100550264","NCT06444815","A Study of VET3-TGI in Patients With Solid Tumors","A Phase 1\u002F1b Study of VET3-TGI Administered Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors","STEALTH-001","Key Inclusion Criteria:\n\n* Have pathologically confirmed, advanced, unresectable, or metastatic solid tumors. Preferred indications include, but are not limited to, breast carcinoma, bladder carcinoma, cervical squamous carcinoma, colorectal carcinoma, esophageal carcinoma, head and neck squamous carcinoma, renal cell carcinoma, ovarian carcinoma, sarcoma, thymoma, and uterine carcinoma.\n* Failed, intolerant to, or refused potentially curative treatment options, including but not limited to, standard of care molecularly targeted agents, immunotherapy (e.g., anti -pembrolizumab\u002FPDL1 antibodies), and chemotherapy\n* Measurable disease as per RECIST 1.1 criteria\n* At least one tumor amenable to safe ITu injections and\u002For biopsies\n* ECOG performance status 0 or 1\n* Demonstrate adequate organ function\n* Must be willing to comply with all protocol procedures and adhere to post-treatment care instructions\n\nAdditional Inclusion criteria exist\n\nKey Exclusion Criteria:\n\n* Prior systemic therapy washout (dependent upon the therapy)\n* Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections.\n* CNS metastases and\u002For carcinomatous meningitis that have not been completely resected or completely irradiated.\n* Prior history of myocarditis\n* Known HIV\u002FAIDS, active HBV or HCV infection.\n* Receiving high dose immunosuppressive medication or has a significant immunodeficiency (e.g. transplant recipient, etc).\n\nAdditional Exclusion criteria exist",{"count":766,"type":21},60,[58],"VET3-TGI is an oncolytic immunotherapy designed to treat advanced cancers. VET3-TGI has not been given to human patients yet, and the current study is designed to find a safe and effective dose of VET3-TGI when administered by direct injection into tumor(s) (called an intratumoral injection) or when given intravenously (into the vein) both alone and in combination with atezolizumab in patients with solid tumors (STEALTH-001).",[28,770,771,772,773,774,775,776,280,61,777,778,779],"Microsatellite Stable Colorectal Cancer","Head and Neck Squamous Cell Carcinoma","Cervical Cancer","Kidney Cancer","Renal Cell Carcinoma","Melanoma Stage IV","Merkel Cell Carcinoma of Skin","Cutaneous Squamous Cell Carcinoma (CSCC)","Urothelial Carcinoma Bladder","Squamous Cell Carcinoma","2026-04-01",{"date":782,"type":39},"2026-04-07",{"date":784,"type":39},"2024-09-16",{"date":786,"type":21},"2027-12-31",{"name":788,"class":85},"KaliVir Immunotherapeutics"]