[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-solid-malignancies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-solid-malignancies":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,52,90,118,147,168,194],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100641893","phase-1-human-adme-study-of-14c-azd1390-100641893",false,"NCT07643870","Human ADME Study of [14C]-AZD1390","A Phase I, Open-label Study to Assess the Absorption, Distribution, Metabolism, and Excretion (ADME) of AZD1390 After a Single Oral Dose of [14C]-AZD1390 in Participants With Advanced Solid Malignancies","Inclusion Criteria:\n\n* Participants with Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, no active anticancer treatment,\n* ECOG performance status of 0 or 1 with no deterioration over the 2 weeks,\n* Predicted life expectancy ≥ 12 weeks,\n* Adequate organ and marrow function,\n* Creatinine clearance ≥ 50 mL\u002Fmin,\n* Regular bowel movements,\n* No cancer-associated cachexia (weight loss).\n\nExclusion Criteria:\n\n* History or presence of myopathy or raised CK \\> 5 × ULN at screening,\n* History of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment,\n* History or presence of clinically significant hepatic disease,\n* History of epileptic disorder or any seizure history unrelated to tumour,\n* History of MDS\u002FAML or with features suggestive of MDS\u002FAML,\n* Predisposition to bleeding\n* History of persisting (\\> 2 weeks) severe cytopenia\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection\n* History of another primary malignancy\n* Persistent toxicities (CTCAE Grade ≥ 2), excluding alopecia, caused by previous anticancer therapy,\n* Spinal cord compression or brain metastases for at least 4 weeks","ALL","18 Years","99 Years",{"count":20,"type":21},8,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a Phase I, multicentre, single-dose, open-label study to assess the absorption, distribution, metabolism, and excretion of \\[14C\\]-AZD1390.",[27],"Advanced Solid Malignancies",[29,30,31,32,33,34,35,36,37,38],"AZD1390","Malignancies","Solid tumor","Glioblastoma","Radioactivity \u002F radiation","Metabolite \u002F metabolism","ATM kinase inhibitor","Pharmacokinetics","Single-dose","ADME","NOT_YET_RECRUITING","2026-06-10",{"date":42,"type":43},"2026-06-12","ACTUAL",{"date":45,"type":21},"2026-06-30",{"date":47,"type":21},"2028-04-12",{"name":49,"class":50},"AstraZeneca","INDUSTRY",2,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":65,"conditions":66,"keywords":67,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100471339","phase-1-study-of-azd9574-as-monotherapy-and-in-combination-with-anti-cancer-agents-in-participants-with-advanced-solid-malignancies-100471339","NCT05417594","Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies","A Modular Phase I\u002FIIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (CERTIS1)","CERTIS1","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group performance status (ECOG PS) with no deterioration over the previous 2 weeks.\n* Progressive cancer at the time of enrollment.\n* Adequate organ and marrow function.\n\nModule 1:\n\nPart A:\n\n\\- Participants must have one of the following: (i) Histologically or cytologically confirmed relapsed advanced ovarian, fallopian tube or primary peritoneal cancer and evidence of a predicted loss of function germline or tumour mutation in one of the following homologous recombination repair genes: BRCA1, BRCA2, PALB2, RAD51C or RAD51D (ii) Histologically or cytologically confirmed HER2-negative carcinoma of the breast with recurrent locally advanced or metastatic disease and evidence of a predicted loss of function germline or tumour mutation in one of the following homologous recombination repair genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.\n\n(iii) Histologically or cytologically confirmed advanced\u002Fmetastatic castration-resistant prostate cancer (CRPC) and evidence of a predicted loss of function germline or tumour mutation in one of the following homologous recombination repair genes:BRCA1, BRCA2, PALB2, RAD51C, or RAD51D (d) Histologically or cytologically confirmed advanced\u002Fmetastatic pancreatic cancer and evidence of a predicted loss of function germline or tumour mutation in one of the following homologous recombination repair genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.\n\n* Must have evaluable disease.\n* Must be suitable for treatment with a PARPi.\n* Must be capable of eating a high fat meal and adhering to fasting restrictions.\n\nPart B:\n\n* Must have metastatic or recurrent locally advanced histologically or cytologically confirmed Human Epidermal growth factor Receptor 2 (HER2)-negative carcinoma of the breast and evidence of a predicted loss of function germline or tumour mutation.\n* Must have at least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter.\n* Participants who have received platinum chemotherapy for advanced breast cancer are eligible to enter the study provided there has been no evidence of disease progression during the platinum chemotherapy.\n* Participants who have received prior platinum-based chemotherapy as neo-adjuvant\u002Fadjuvant treatment are eligible provided at least 12 months have elapsed between the last dose of platinum-based treatment and first dose of study intervention.\n\nModule 2:\n\n* Must be suitable for treatment with TMZ and have IDH1\u002F2-mutant glioma.\n* Should have progressive disease after prior radiation therapy and one prior line of alkylating chemotherapy for their disease.\n* Recurrent disease must be evaluable by MRI.\n* Female participants of childbearing potential (CBP) must have a negative pregnancy test result at screening and prior to each cycle administration of AZD9574 and TMZ.\n* Adequate organ and marrow function.\n\nModule 3:\n\nPanel 1\n\n* Must consent to provide mandated blood samples and archival\u002Ffresh tumour tissue for confirmatory tests of their cancer using central laboratory.\n* Participants must have one of the following:\n\n  1. Histologically or cytologically confirmed HER2-negative carcinoma of the breast with recurrent locally advanced or metastatic disease and evidence of a predicted loss of function germline or tumour mutation in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D,\n  2. Histologically or cytologically confirmed relapsed advanced ovarian, fallopian tube or primary peritoneal cancer and evidence of a predicted loss of function germline or tumour mutation in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D\n  3. Histologically or cytologically confirmed advanced\u002Fmetastatic castration-resistant prostate cancer (CRPC) and evidence of a predicted loss of function germline or tumour mutation in in BRCA1, BRCA2, PALB2, RAD51C or RAD51D.\n  4. Histologically or cytologically confirmed advanced\u002Fmetastatic pancreatic cancer and evidence of a predicted loss of function germline or tumour mutation in in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.\n* Participants must have evaluable disease: at least one measurable and\u002For non-measurable lesions per RECIST 1.1\n* Must be refractory to standard therapy or for which no standard therapy exists.\n* Any 2 participants in this panel must meet the following CNS criteria:\n\n  1. Must have previously treated and progressing or untreated brain metastases confirmed by brain MRI at screening that do not need immediate local therapy.\n  2. Should have stable neurological function for ≥ 14 days prior to signing the main study ICF.\n  3. If receiving steroids, the dose should be stable or decreasing for ≥ 14 days prior to signing the main study ICF.\n\nPanel 2\n\n* Must be suitable for treatment with TMZ and have IDH1\u002F2-mutant glioma.\n* Should have progressive disease after prior radiation therapy and one prior line of alkylating chemotherapy for their disease.\n* Recurrent disease must be evaluable by MRI and at least 1 tumour of \\> 1cm diameter detected on MRI.\n* Formalin-fixed, paraffin-embedded (FFPE) tumour sample from the primary cancer must be available for central testing\n* Adequate organ and marrow function (in the absence of transfusions or growth factor support within 14 days prior to enrolment)\n\nPanel 3\n\n* Must consent to provide mandated blood samples and archival\u002Ffresh tumour tissue for confirmatory tests of their cancer using central laboratory.\n* Must have histologically or cytologically confirmed HER2-negative carcinoma of the breast with recurrent locally advanced or metastatic disease and evidence of a predicted loss of function germline or tumour mutation in in BRCA1, BRCA2, PALB2, RAD51C or RAD51D .\n* Must have evaluable disease: at least one measurable and\u002For non-measurable lesions per RECIST 1.1 .\n* Must be refractory to standard therapy or for which no standard therapy exists.\n\nModule 4:\n\nPart A:\n\n* Must have the following HER2 status:\n\n  1. Breast cancer must be IHC 3+ or IHC 2+\u002FISH-positive or IHC 2+\u002FISH-negative or IHC 1+ as determined by local testing using current American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) guidelines for scoring HER2 + breast cancer.\n  2. Gastric cancer should be IHC 3+ or IHC 2+\u002FISH-positive based on local tissue testing results.\n  3. Participants with non-breast and non-gastric cancers must have HER2-overexpression (IHC 3+ or IHC 2+; as determined by local testing using current ASCO-CAP guidelines for gastric IHC scoring).\n  4. Participants with NSCLC will also be eligible based on the presence of a HER2activating mutation.\n* Must have progressed following at least one prior systemic treatment and not more than 2 prior lines of cytotoxic therapy for metastatic or advanced disease and have no satisfactory alternative treatment option.\n* Should have unresectable, or metastatic disease based on most recent imaging. The following tumour types are eligible for this study: Breast cancer, Non-Small Cell Lung Cancer, Colorectal Cancer, Bladder Cancer, Ovarian Cancer, Gastric Cancer, and Other tumour types ( unresectable or metastatic biliary tract cancer, cervical cancer, endometrial cancer, and pancreatic adenocarcinoma).\n* Adequate organ and marrow function (in the absence of transfusions or growth factor support) within 14 days prior to the first dose of study intervention.\n* Left ventricular ejection fraction (LVEF) ≥ 50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before start of treatment.\n* Must have at least one lesion not previously irradiated (or with evidence of disease progression following radiation).\n* Non-sterilised male participants who are sexually active with a female partner of CBP must use a condom with spermicide from screening to approximately 6 months after the last dose of study intervention.\n* Male participants must refrain from fathering a child or donating sperm during the study and for approximately 6 months after the last dose of study intervention.\n\nPart B - All participants:\n\n* Histologically documented unresectable or metastatic breast cancer.\n* Metastatic or recurrent locally advanced unresectable histologically or cytologically confirmed HER2-low or HER2-ultralow breast carcinoma.\n* No prior chemotherapy for locally advanced unresectable or metastatic breast cancer.\n\nPart B - Participants with brain metastases:\n\n* Stable neurological function for ≥ 14 days prior to signing the main study ICF.\n* If receiving steroids, the dose should be stable or decreasing for ≥ 14 days prior to signing the main study ICF.\n* Must not have progressing or untreated (stable or progressing) brain metastases.\n\nPart B - Participants in CNS cohort:\n\n\\- Untreated brain metastases, previously treated and stable or progressing brain metastases on screening contrast brain MRI\u002FCT scan, not needing immediate local therapy.\n\nModule 5 :\n\n* Should have unresectable, or metastatic disease based on most recent imaging. The following tumour types are eligible for this study: TNBC, Endometrial cancer, Ovarian Cancer and CRPC.\n* Must have progressed following at least one prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment option.\n* Must have at least one lesion, not previously irradiated that can be accurately measured at baseline as ≥ 10 mm in the longest diameter.\n* Non-sterilised male participants who are sexually active with a female partner of CBP must use a condom with spermicide from screening to approximately 4 months after the last dose of study.\n* Male participants must refrain from fathering a child or donating sperm during the study and for approximately 4 months after the last dose of study intervention.\n* Adequate organ and marrow function (in the absence of transfusions or growth factor support) within 14 days prior to the first dose of study intervention.\n\nModules 1, 2 and 3:\n\n* Female participants of CBP:\n\n  1. Must have a negative pregnancy test result at screening and prior to each cycle of study treatment.\n  2. If sexually active with a non-sterilised male partner, must use at least one highly effective method of birth control plus a barrier method from screening to approximately 6 months after the last dose of study treatment.\n* Female participants must not breastfeed and must not donate or retrieve ova for their own use from screening to approximately 6 months after the last dose of study treatment.\n* Non-sterilised male participants who are sexually active with a female partner of CBP must use a condom with spermicide from screening to approximately 3 months after the last dose of study intervention.\n* Female partners of male participants should use at least one highly effective method of contraception from screening to approximately 3 months after the last dose of study intervention of the male participant.\n* Male participants must refrain from fathering a child or donating sperm from the start of study intervention and for approximately 3 months after the last dose of study intervention.\n\nModules 4 and 5:\n\n* Female participants of CBP:\n\n  1. Must have a negative pregnancy test result at screening and prior to each cycle of study intervention.\n  2. If sexually active with a non-sterilised male partner, must use at least one highly effective method of birth control in combination with one effective method (male condom plus spermicide) from screening until approximately 7 months after the last dose of study intervention.\n* Female participants must not breastfeed and must not donate or retrieve ova for any use from screening to approximately 7 months after the last dose of study intervention.\n* Participants must provide an existing FFPE tumour sample for retrospective, tissue-based IHC testing in a central laboratory to determine HER2 expression and other correlatives.\n* ECOG performance status of 0 or 1.\n* Participants recruited specifically for PD evaluation must have at least 1 tumour suitable for paired biopsies and be willing to consent to pre-treatment and on-treatment biopsies.\n\nExclusion Criteria:\n\n* Major surgery within 4 weeks of the first dose of study intervention.\n* Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study intervention.\n* With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study intervention.\n* Any known history of persisting severe pancytopenia due to any cause.\n* Spinal cord compression unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of \\> 10 mg prednisone\u002Fday or equivalent for at least 4 weeks prior to start of study intervention.\n* History of uncontrolled seizures or with need for concurrent administration of more than 2 antiepileptic drugs, or history of epileptic disorder or any seizure history unrelated to tumour.\n* History of severe brain injury or stroke.\n* Any evidence of severe or uncontrolled systemic diseases including active bleeding diatheses, active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).\n* Uncontrolled intercurrent illness within the last 12 months.\n* Any known predisposition to bleeding.\n* Patients with myelodysplastic syndrome (MDS)\u002Facute myeloid leukaemia (AML) or with features suggestive of MDS\u002FAML.\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD9574.\n* Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).\n* Known contra-indication to gadolinium-enhanced Magnetic Resonance Imaging (MRI) or, if applicable, not able to be maintained on a stable or decreasing dose of corticosteroid regimen (no increase for 7 days) prior to the baseline MRI.\n* Any concurrent anti-cancer therapy or concurrent use of prohibited medications.\n\nModule 1:\n\nPart A:\n\n* Have received \\> one prior line of therapy in any setting with a PARPi-based regimen.\n* Participants with an INR \\>1.5 unless the patient is receiving non-vitamin K antagonist oral anticoagulants.\n* Participants with leptomeningeal disease (LMD) unless the LMD is of low volume or is previously treated and the participant is asymptomatic or minimal symptoms.\n* Participants with insulin-dependent diabetes.\n* Currently on ARA treatment.\n\nPart B:\n\n* Participants with an International Normalised Ratio (INR) \\>1.5 unless the patient is receiving non-vitamin K antagonist oral anticoagulants.\n* Participants with LMD are excluded unless the LMD is of low volume or is previously irradiated and the participant is asymptomatic from the LMD.\n\nModule 2:\n\n* Received a PARPi previously.\n* Known hypersensitivity to TMZ or dacarbazine or known history of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD9574.\n* Have received \\> 1 prior line of alkylating chemotherapy regimen. Participants who have received procarbazine, lomustine (CCNU), vincristine (PCV) as a prior line of treatment are not allowed.\n* Previously experienced Grade 4 haematological toxicities or Grade 3 neutropenia associated with infections, or Grade 3 thrombocytopenia with clinically significant bleeding during prior alkylating chemotherapy.\n* Received bevacizumab within the last 6 months.\n* Not requiring continuous corticosteroids at a dose of \\>10 mg prednisone\u002Fday or equivalent for at least 4 weeks prior to start of study intervention.\n\nModule 3:\n\nAll Panels\n\n* Positive Allen's test\n* BMI \\> 30.0 kg\u002Fm2 or body weight \\> 100.0 kg\n* Suffer from claustrophobia.\n* Implanted metal devices or implants containing metal.\n* An INR \\>1.5\n* Taking acid-reducing agents.\n\nPanel 1\n\n* Received \\> 1 prior line of therapy in any setting with a PARPi-based regimen\n* Participants with LMD\n\nPanel 2\n\n* Received a PARPi previously.\n* Known hypersensitivity to TMZ.\n* Received \\> 1 prior line of alkylating chemotherapy regimen.\n* Previously experienced Grade 4 haematological toxicities or Grade 3 neutropenia associated with infections, or Grade 3 thrombocytopenia with clinically significant bleeding during prior alkylating chemotherapy.\n* Received bevacizumab within the last 6 months.\n\nPanel 3\n\n* Received \\> one prior line of therapy in any setting with a PARPi-based regimen.\n* Participants with LMD.\n\nModule 4:\n\nAll participants:\n\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of T-DXd and within 4 weeks for continuous corticosteroids at a dose of approximately \\> 10 mg prednisone\u002Fday or equivalent.\n* Should not have received more than 2 prior lines of systemic cytotoxic therapy.\n* Prior treatment with HER2 directed TOPO1i ADCs and prior AZD9574 is not permitted.\n* Must not enter the study if they received chloroquine\u002Fhydroxychloroquine \\\u003C 14 days prior to the first dose.\n* Presence of unresolved toxicities from previous anti-cancer therapy, defined as toxicities not yet resolved to Grade ≤ 1 or baseline.\n* Known history of prior platelet transfusion(s) or febrile neutropenia in the advanced disease treatment setting.\n* Medical history of myocardial infarction. Participants with troponin levels above ULN at screening and without any myocardial related symptoms.\n* History of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis.\n* Additional lung-related exclusion criteria: (a) Lung-specific intercurrent clinically significant illnesses (b) Any autoimmune, connective tissue or inflammatory disorders (c) Prior pneumonectomy.\n* Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy.\n* Known hypersensitivity to T-DXd, any of the excipients or other mAbs.\n* History of another primary malignancy.\n* An uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.\n* Active primary immunodeficiency, known uncontrolled active HIV infection or active hepatitis B or hepatitis C infection.\n\nPart A (dose escalation):\n\n\\- Participants with brain metastases are excluded unless asymptomatic, treated, and participant is clinically stable and not requiring continuous corticosteroids at a dose of \\> 10 mg prednisone\u002Fday or equivalent for at least 4 weeks prior to study intervention.\n\nPart B (dose expansion):\n\n\\- Prior systemic cytotoxic-containing treatment in the metastatic\u002Flocally advanced unresectable setting.\n\nPart B (dose expansion) - Participants with Brain Metastases:\n\n* Known and symptomatic leptomeningeal disease.\n* Spinal cord compression.\n\nModule 5:\n\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of Dato-DXd and within 4 weeks for continuous corticosteroids at a dose of approximately \\> 10 mg prednisone\u002Fday or equivalent.\n* Corticosteroid mouthwash formulations are permitted to prevent and manage certain AEs.\n* Prior anti-cancer treatments:\n\n  1. Should not have received more than 2 prior lines of systemic cytotoxic therapy\n  2. Prior treatment with PARPi is permitted\n  3. Prior TOPO1 inhibitor therapy is NOT permitted\n  4. Prior treatment with TROP2-directed ADCs is NOT permitted.\n  5. Prior radiation therapy requires the washout periods.\n* Must not enter the study if they received chloroquine \u002F hydroxychloroquine \\\u003C 14 days prior to the first dose.\n* History of another primary malignancy.\n* History of non-infectious ILD\u002Fpneumonitis including radiation pneumonitis that required steroids, has current or suspected ILD\u002Fpneumonitis.\n* Clinically severe pulmonary function compromise.\n* Clinically significant corneal disease.\n* History of severe hypersensitivity reactions to Dato-DXd, any of the excipients or to other mabs.\n* Participant is pregnant or breastfeeding or planning to become pregnant.","130 Years",{"count":62,"type":21},695,[24,64],"PHASE2","This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9574 individually and in combination with anti-cancer agents in participants with advanced cancer that has recurred\u002Fprogressed.",[27],[68,69,70,71,72,73,74,75,76,77,78,79],"Poly ADP-ribose Polymerase inhibitor (PARPi)","Anti-tumour","Breast cancer","Ovarian cancer","Fallopian tube cancer","Prostate cancer","Pancreatic cancer","Soft tissue disease","Glioma","Astrocytoma","Oliogodendroglioma","Solid tumours","RECRUITING","2026-06-01",{"date":83,"type":43},"2026-06-02",{"date":85,"type":43},"2022-06-24",{"date":87,"type":21},"2027-10-13",{"name":49,"class":50},32,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":105,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":20},"100610089","phase-1-a-study-to-evaluate-the-safety-tolerability-and-efficacy-of-bms-986523-alone-and-in-combination-with-anti-cancer-agents-in-participants-with-advanced-solid-malignancies-100610089","NCT07223047","A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies","A Phase 1\u002F2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 As Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies","Inclusion Criteria\n\n* Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification).\n* Participants must, for Arm D, have a PD-L1 expression (≥50%).\n* Participants must have previously received, be ineligible for, or decline (after having been provided adequate information to make an informed decision) the protocol defined standard of care (SoC) treatments.\n\nExclusion Criteria\n\n* Participants must not have untreated central nervous system (CNS) metastases.\n* Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.\n* Participants must not have a history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis. A history of radiation pneumonitis in the radiation field is permitted.\n* Participants must not have a history of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":98,"type":21},252,[24,64],"The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies",[27,102,103,104],"Non-small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)","Pancreatic Ductal Adenocarcinoma (PDAC)",[102,103,104,106,107,108],"Pancreatic Cancer","Lung Cancer","Kirsten rat sarcoma viral oncogene homolog (KRAS)","2026-05-26",{"date":111,"type":43},"2026-05-28",{"date":113,"type":43},"2025-11-25",{"date":115,"type":21},"2028-10-13",{"name":117,"class":50},"Bristol-Myers Squibb",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":146},"100587354","phase-1-phase-i-study-of-the-safety-tolerability-and-efficacy-of-an-engineered-mitochondrial-vaccine-in-advanced-solid-tumors-100587354","NCT06927297","Phase I Study of the Safety, Tolerability, and Efficacy of an Engineered Mitochondrial Vaccine in Advanced Solid Tumors","A Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of an Engineered Mitochondrial Vaccine in Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n1. Patients aged 18 to 75 years at the time of acquisition informed consent form.\n2. Patients with advanced malignant solid tumors such as non-small cell lung cancer or colorectal cancer, confirmed by histology or cytology, who are unable to receive or tolerate standard treatments, or who refuse standard treatments, exhibit positive expression of target antigens in the tumor tissue.\n3. The presence of at least one measurable or evaluable lesion according to RECIST v1.1 criteria.\n4. Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2.\n5. Predicted survival time ≥3 months.\n6. The main organs are functioning well and the following requirements are met within 7 days before receiving treatment:\n\n   ① Hemoglobin (HGB) ≥80 g\u002FL (no blood transfusion within 14 days); Absolute neutrophil count (ANC) \\>1.5×109\u002FL; White blood cell count ≥3.0×109\u002FL; Platelet count (PLT) ≥80×109\u002FL;\n\n   ② Total bilirubin ≤1.5× upper limit of normal value (ULN); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5×ULN; If there was liver metastasis, ALT or AST≤5×ULN;\n\n   ③ Creatinine (SCr) ≤1.5×ULN or creatinine clearance (CRCI) estimated by Cockcroft-Gault formula ≥60 mL\u002Fmin;\n\n   ④ Prothrombin time (PT), international normalized ratio (INR) ≤1.5×ULN (unless anticoagulation with warfarin);\n\n   ⑤ Cardiac function: left ventricular ejection fraction ≥50%. QTcF interval ≤450 ms.\n7. Men of childbearing potential and women of childbearing age voluntarily use effective contraceptive methods (e.g., condoms, intrauterine devices, spermicides) from the time of signing the informed form until 6 months after the completion of vaccination, and contraceptive use is not allowed. Female cancer patients who have a negative pregnancy test and agree not to breastfeed during the study and for at least 18 months after receipt of the trial vaccine;\n8. The washout period of previous anti-tumor therapy should be at least 4 weeks, and the washout period of molecular targeted drugs should be at least 5 half-lives. Palliative radiotherapy needs to have been completed for at least 2 weeks; Chest radiation therapy needed to have been completed for at least 3 months, and major surgery needed to have been completed with at least 4 weeks of recovery.\n\nExclusion Criteria:\n\n1. The patient has a history of other tumors in the past, except for the history of malignant tumors that have been cured and have not recurred within 5 years before screening, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical cancer in situ, and intramucosal cancer of the gastrointestinal tract, which the investigator considers to be eligible for enrollment.\n2. Have any uncontrolled clinical diseases (e.g., diseases of the respiratory system, circulatory system, digestive system, nervous system, hematologic system, urogenital system, endocrine system) or psychiatric or other major medical condition that the investigator considers to interfere with the provision of informed consent, to interfere with the interpretation of the trial results, to pose a risk to the study participants, or to otherwise interfere with the achievement of the study objectives.\n3. Have any active autoimmune disease or a history of autoimmune disease. Participants with asthma for which medical intervention with bronchodilators was required could not be included.\n4. Allergy to the trial drug (including any excipients). Previous history of severe allergy to any drug, food or vaccination, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc.\n5. There are contraindications to subcutaneous injection.\n6. Received prior antitumor therapeutic vaccine or cellular immunotherapy.\n7. Participated in other drug or device clinical trials 4 weeks before screening.\n8. Study participants on systemic therapy with corticosteroids (\\>10 mg\u002F day of prednisone or equivalent doses of other glucocorticoids) or other immunosuppressive agents within 14 days before the first dose of vaccine. Inhaled or topical steroids and adrenal hormone replacement at a therapeutic dose of prednisone of 10 mg or less per day were allowed in the absence of active autoimmune disease.\n9. Before the first dose of the study drug. Any toxic effects from previous antineoplastic therapy have not recovered to NCI CTCAE grade 5.0 ≤1 (any degree of alopecia, other than grade 2 previous platinum-based treatment-related neuropathy).\n10. Has active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.\n11. Have a history of substance abuse or known medical, psychological, or social conditions such as alcohol or drug abuse.\n12. Have received any vaccine within 30 days before receiving the study vaccine or plan to receive any vaccine other than the study vaccine during the study.\n13. The presence of any other factor that was deemed by the investigator to preclude study participant entry into the trial or that study participant had any medical condition that could interfere with the assessment of the safety or efficacy of the study treatment.\n14. Study participants who were unwilling or unable to comply with study requirements.","75 Years",{"count":127,"type":21},12,[24],"This study is a dose-escalation, prospective clinical trial to assess the safety, tolerability, and preliminary therapeutic efficacy of engineered mitochondria expressing specific tumor antigen in patients with advanced solid tumors.",[131,27],"Advanced Solid Tumor Malignancies",[133,134,135],"advanced solid tumors","cancer vaccines","engineered mitochondria","2026-03-15",{"date":138,"type":43},"2026-03-17",{"date":140,"type":43},"2025-05-09",{"date":142,"type":21},"2028-04-30",{"name":144,"class":145},"West China Hospital","OTHER",1,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":146},"100621273","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-pk-and-preliminary-efficacy-of-bc2027-in-patients-with-advanced-solid-malignancies-100621273","NCT07368478","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC2027 in Patients With Advanced Solid Malignancies","A Phase Ⅰa\u002FⅠb, Open-Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC2027 in Patients With Advanced Solid Malignancies","Inclusion Criteria:\n\n1. Provide written informed consent.\n2. Be at least 18 years old.\n3. Have an Eastern Cooperative Group (ECOG) performance status (PS) of 0 or 1.\n4. Have a life-expectancy of at least 3 months based on the Investigator's assessment.\n5. Patients with advanced solid tumors confirmed by histology or cytology, who have failed standard therapy, have no available standard therapy, or are intolerant to standard therapy.\n6. Phase 1a (dose escalation, Part 1)\n\n   a. Have an advanced solid malignancy confirmed by histologic or cytologic examination that is known to express GPC3 including, but not limited to, HCC, NSCLC (particularly squamous cell NSCLC), sarcoma (undifferentiated), ovarian clear cell adenocarcinoma (OCCC), esophageal squamous cell carcinoma (ESCC).\n7. Must provide either a previously archived tumor tissue sample or a fresh core or excisional biopsy from a site that was not irradiated. There must be at least 3-5 unstained sections. A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred to slides, and fresh biopsies are preferred over archival tissue. If archival tissue cannot be provided and a fresh biopsy cannot be obtained in Part 1, an exemption may be provided by the Sponsor.\n8. Must have adequate organ function within 7 days prior to the start of study treatment as defined below:\n\n   Hematological\\* ANC ≥1,500\u002FμL or ≥1.5×109\u002FL Platelets ≥100,000\u002FμL or ≥100×109\u002FL (For HCC patients, PLTs ≥75×109\u002FL) Hemoglobin ≥9.0 g\u002FdL Kidney Function Creatinine clearance (CrCl)\\*\\* ≥50 mL\u002Fmin Liver Function Total Bilirubin (TBIL) ≤1.5×ULN, or direct bilirubin ≤ULN (patients with total bilirubin level \\>1.5×ULN).\n\n   AST (SGOT) and ALT (SGPT) ≤2.5×ULN (≤5×ULN in patients with liver metastases) Coagulation International Normalized Ratio (INR), Prothrombin Time (PT), and activated partial thromboplastin time (aPTT) :INR≤1.5; PT and aPTT ≤1.5×ULN or within a therapeutic range if on an anticoagulant.\n\n   \\* Blood transfusion or growth factor support is not allowed within 14 days prior to blood sampling.\n\n   \\*\\* CrCl should be calculated according to institutional standards.\n9. Must have at least one measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (In the dose escalation part of the study (Part 1), patients without measurable lesions may be enrolled if they have evaluable disease and are approved by the sponsor). Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n10. Must agree to use highly effective contraceptive measures if patient is a man or woman of childbearing potential. Highly effective contraceptive measures include measures like hormonal contraceptives, intrauterine devices, vasectomy, or tubal ligation, and others (Section 5.3), from the time of signing the informed consent until 6 months after the last dose of the study drug. Women of childbearing potential (WCBP) must have a negative blood or urine pregnancy test within 7 days prior to the first dose of study drug. Female patients with surgically sterile or are postmenopausal for at least 12 months without an alternative medical cause are also allowed.\n\nAdditional Inclusion Criteria for Part 2\n\nIn addition to fulfilling the inclusion for Part 1, patients enrolling in cohorts in Part 2\u002FPhase Ib must have:\n\n1. Cohort 1 (NSCLC Cohort)\n\n   1. Positive expression of GPC3 confirmed by immunohistochemistry (IHC) assay, or with existing prior IHC test report documenting GPC3 positivity.\n   2. Patients with non-small cell lung cancer (NSCLC) who have failed no more than 3 prior lines of systemic antineoplastic therapy.\n2. Cohort 2 (HCC Cohort)\n\n   1. IHC evidence of GPC3 expression on archival tumor or a fresh biopsy unless biopsy is not feasible or safe and with approval of the Sponsor.\n   2. The subject has received treatment with 1 prior regimen in the first line advanced setting consisting of an appropriate monoclonal antibody (mAb) targeting PD-1 or PD-L1 with an appropriate mAb targeting CTLA-4 and\u002For an appropriate tyrosine kinase inhibitor (TKI) or mAb targeting vascular endothelial growth factor (VEGF, e.g., bevacizumab). The subject must have progressed, demonstrated intolerance, or refused such treatment. If a subject had refused treatment, the reasons for such must be documented in the records and case report form (CRF).\n   3. The patient must have Barcelona Clinic Liver Cancer (BCLC) stage B or C HCC (See Appendix 1), not amenable to locoregional therapy or refractory to locoregional therapy likely to result in reasonable clinical benefit, and not amenable to a curative treatment approach.\n   4. The subject has a Child-Pugh A score (See Appendix 2) within 7 days of study drug treatment.\n3. Cohort 3 (Advanced GPC3 expressing solid cancer).\n\n   1. GPC3 positivity confirmed by IHC assay, or documented in prior IHC reports.\n   2. Patients excluding Cohort 1 and Cohort 2 with failure of ≤ 2 prior lines of systemic antineoplastic therapy.\n\nExclusion Criteria:\n\nPatients who meet any of the exclusion criteria must not be enrolled in the study.\n\n1. Prior treatment with GPC3-targeted ADC.\n2. Prior treatment with systemic anticancer treatment, including investigational agents, within a period that is less than five half-lives or 2 weeks before the start of treatment, whichever is shorter.\n3. Known hypersensitivity or delayed hypersensitivity reactions to the same class and\u002For any component of BC2027.\n4. Treatment with strong CYP3A4 inhibitors or inducers, and P-gp inhibitors within 14 days or 5 half-lives whichever is shorter, before the first dose.\n5. For patients with advanced NSCLC:\n\n   a. Positive for driver oncogenes: including EGFR mutation, ALK gene fusion, ROS1 gene fusion, KRAS-G12C mutation, c-MET (exon 14 skipping, MET amplification and overexpression), HER2 mutation, RET gene fusion, etc.\n\n   For HCC patients:\n   1. Received local hepatic therapy including, but not limited to, surgery, radiotherapy, hepatic arterial embolization (TAE), hepatic arterial chemoembolization (TACE), hepatic arterial perfusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) within 4 weeks prior to initiation of the study drug.\n   2. History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy (eg, no lactulose, rifaximin, etc if used for purposes of hepatic encephalopathy)\n   3. The patient has main portal vein thrombosis ((i.e. thrombosis in the main trunk of the portal vein, with or without blood flow) on baseline imaging.)\n   4. Documented gastrointestinal bleeding within past 6 months or at high risk of gastrointestinal bleeding per investigator's clinical judgement, due to esophageal varices, active gastric or duodenal ulcers.\n6. Active and severe viral infections meeting the following criteria:\n\n   1. Known HIV seropositivity.\n   2. Known active hepatitis B (Screening for hepatitis B is not required for non-HCC patients):\n\n      * For HCC patients: HBV DNA \\> 2000 IU\u002FmL. (For patients with positive hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibodies (anti-HBcAb) with detectable HBV DNA (≥10 IU\u002FmL)\\], patients with the following conditions may be enrolled: patients who have received antiviral therapy and had sufficient suppression of viral replication before enrollment (HBV DNA ≤ 2000 IU\u002Fml), and patients must continue to receive antiviral therapy during the study and for 6 months after the last dose.)\n      * For other solid malignancies patients: HBsAg positive and HBV-DNA titer \\> 500 IU\u002FmL or \\> 2500 copies\u002FmL.\n   3. Known active hepatitis C :\n\n      * For HCC patients: Co-infection of HBV and HCV. (The following conditions are allowed for inclusion: positive HCV RNA test or positive HCV antibody, and patients complying with local medical practice for treatment.)\n7. Severe immunodeficiency requiring systemic corticosteroid therapy at a prednisone-equivalent dose (\\>10 mg\u002Fday), or any other systemic immunosuppressive therapy, unless approved by the sponsor.\n8. A history of allogeneic tissue or solid organ transplantation.\n9. A history of radiation pneumonitis, or receipt of radiotherapy within 2 weeks prior to the initiation of study treatment.\n\n   Note: Patients must have recovered from radiation-related toxicities and must not be receiving corticosteroid treatment. A 1-week washout period is permitted for palliative radiotherapy (≤ 2 weeks of radiotherapy) for non-central nervous system (non-CNS) diseases.\n10. Unstable central nervous system (CNS) metastases and\u002For carcinomatous meningitis. For patients with previously treated brain metastases who have achieved radiological stability (i.e., no evidence of disease progression on repeated imaging examinations for at least 4 weeks, as documented in imaging obtained during screening; and no requirement for corticosteroid treatment for at least 14 days prior to the first dose), routine brain imaging is not required during screening.\n11. Uncontrolled pleural effusion, ascites, or pericardial effusion at the time of screening.\n12. A history of interstitial lung disease (ILD) or drug-related interstitial lung disease, or any evidence of clinically active interstitial lung disease.\n13. Clinically significant cardiovascular disease, including but not limited to:\n\n    * Congestive heart failure (CHF) of New York Heart Association (NYHA) functional class III or higher, or left ventricular ejection fraction (LVEF) \\\u003C 50%.\n    * Unstable angina pectoris or myocardial infarction occurring within 6 months prior to enrollment.\n    * Severe cardiac arrhythmias, including but not limited to complete left bundle branch block, atrioventricular block of second degree or higher, and ventricular tachycardia (including frequent ventricular premature beats).\n    * Clinically uncontrolled hypertension, defined as systolic blood pressure (SBP) ≥ 160 mmHg and\u002For diastolic blood pressure (DBP) ≥ 100 mmHg despite anti-hypertensive medication use.\n14. Clinically significant electrocardiogram (ECG) abnormalities, including any of the following:\n\n    * Markedly prolonged QT\u002FQTc interval on screening ECG (i.e., repeated measurements demonstrating a QTc interval \\> 470 ms) (QTcF calculated based on the Fridericia formula).\n    * A history of risk factors for torsades de pointes, such as congestive heart failure, hypokalemia, family history of long QT syndrome, and other risk factors.\n15. Grade ≥ 2 peripheral neurotoxicity or neuropathy, and other toxicities caused by prior anti-tumor therapy that have not resolved to Grade ≤ 1 (per CTCAE Version 5.0). Exceptions include alopecia, skin hyperpigmentation, other events deemed tolerable by the investigator, or specific-grade toxicities specified in the inclusion\u002Fexclusion criteria of this study.\n16. Patients with active or chronic corneal disease, other active ophthalmic diseases requiring continuous treatment, or any clinically significant corneal disease that prevents adequate monitoring for drug-induced keratopathy.\n17. Active infections requiring systemic anti-infective therapy.\n18. Poor patient compliance, or unwillingness or inability to follow the procedures specified in the study protocol.",{"count":155,"type":21},180,[24],"This is a phase Ia\u002FIb, open-label, dose escalation and dose expansion study designed to evaluate the safety, tolerability, PK, and preliminary anticancer activity of BC2027 in patients with advanced solid Malignanciesr",[27],"2026-01-21",{"date":161,"type":43},"2026-01-26",{"date":163,"type":43},"2025-11-24",{"date":165,"type":21},"2028-06",{"name":167,"class":50},"Biocity Biopharmaceutics Co., Ltd.",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":180,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":193},"100518248","phase-1-safety-and-tolerability-study-of-gim-122-in-subjects-with-advanced-solid-malignancies-100518248","NCT06028074","Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies","A First-in-Human, Open-Label, Phase 1\u002F2 Dose-Escalation With Enrichment and Dose-Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of GIM-122 as a Single Agent in Adult Subjects With Advanced Solid Malignancies","Inclusion Criteria:\n\nGeneral\n\n* Written informed consent\n* ECOG performance status 0-1.\n* Laboratory assessment 28 days prior to enrollment for assessment of acceptable cardiac, renal and hepatic functions\n* Recommended Double methods of contraception 90-days post treatment Cancer Specific\n* Histologically or cytologically confirmed locally advanced\u002Funresectable or metastatic solid tumor\n* Received FDA approved treatment of PD-1 inhibitor or PD-L1 inhibitor for advance malignant tumors and have progressed\u002Frelapsed, are refractory, or intolerant\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1\n* Had prior therapy with PD-1\u002FPD-L1 inhibitors. Other checkpoint inhibitors (ie, CTLA4, LAG3) are permitted if they did not lead to treatment discontinuation\n* No other lines of therapy that are available\n\nExclusion Criteria:\n\nGeneral\n\n* Enrolled in any other interventional clinical trial, starting within 4 weeks of the first dose of GIM-122 and throughout the duration of the study, or is receiving other therapy directed at their malignancy\n* Women who are pregnant or breastfeeding\n* History of cardiac issues, pulmonary embolism, active and clinically significant bacterial, fungal, or viral infection ≤ 6 months prior to dosing\n* Contraindications to the imaging assessments or other study procedures that subjects will undergo or any medical or social condition that, in the opinion of the investigator, might place a subject at an increased risk, affect compliance, or confound safety or other clinical study data interpretation Cancer Specific\n* Current second malignancy at other sites\n* Leptomeningeal disease\n* Spinal cord compression\n* Symptomatic or new or enlarging central nervous system (CNS) metastases\n\nTreatment-specific Exclusion Criteria\n\n* Ongoing toxicity \\> Grade 1 from prior therapy according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0\n* Has undergone a major surgery \\\u003C 1 month prior to administration of GIM-122\n* Has received radiation therapy within 2 weeks prior to administration of GIM-122\n* Has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem cell transplantation at any time\n* Has received systemic anti-cancer therapy within 2 weeks and cytotoxic agents that have a major delayed toxicity within 4 weeks, of the first dose of GIM-122\n* Prior treatment with other immune modulating agents within \\\u003C 4 weeks prior to the first dose of GIM-122.\n* Has a diagnosis of immunodeficiency, either primary or acquired\n* Has received treatment with systemic steroids or any form of immunosuppressive therapy within 14 days prior to administration of GIM-122\n* Has active or prior history of autoimmune disease, including ulcerative colitis and Crohn's disease, or any condition that requires systemic steroids.\n* Has a known severe intolerance to or hypersensitivity reactions to monoclonal antibodies, Fc-bearing proteins, or IV immunoglobulin preparations; prior history of human anti-human antibody response; known allergy to any of the study medications, or excipients in the various formulations of any agent.\n* Has received live vaccines within 30 days of study initiation (inactivated vaccines are allowed; seasonal vaccines should be up to date \\> 30 days prior to administration of GIM-122).",{"count":176,"type":21},111,[24,64],"GIM-122 is a first-in-class, humanized immunoglobulin G1 kappa dual functioning monoclonal antibody (DFA). This phase 1 \u002F 2 study plans to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of intravenous (IV) administration of GIM-122 in adults with advanced malignancies.",[27],[181,182,183],"solid tumor","advanced malignancies","GIM-122","2025-07-08",{"date":186,"type":43},"2025-07-11",{"date":188,"type":43},"2023-12-12",{"date":190,"type":21},"2026-12",{"name":192,"class":50},"Georgiamune Inc",11,{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"100463474","phase-1-a-phase-iii-study-to-evaluate-the-safety-pharmacokinetics-and-efficacy-of-prj1-3024-in-subjects-with-advanced-solid-tumors-100463474","NCT05315167","A Phase I\u002FII Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors","A Phase 1\u002F2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Prime Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors","\\- Key Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced (unresectable) or metastatic r\u002Fr solid tumors for which no standard therapy is available or for whom standard therapy is considered unsuitable or intolerable.\n* Male or non-pregnant, non-lactating female subjects age ≥18 years.\n* ECOG Performance Status 0\\~1.\n* Has at least 1 measurable lesion as defined by RECIST 1.1 criteria .\n* Life expectancy of \\>3 months, in the opinion of the Investigator.\n* Able to take oral medications and willing to record daily adherence to investigational product.\n* Adequate hematologic parameters unless clearly due to the disease under study.\n* Adequate renal and hepatic function\n* Able to understand and willing to sign a written informed consent form.\n\nKey Exclusion Criteria:\n\n* History of another malignancy\n* Known symptomatic brain metastases requiring \\>10 mg\u002Fday of prednisolone.\n* Significant cardiovascular disease.\n* Known active HBV, HCV, AIDS-related illness.\n* Has received a live vaccine within 30 days.\n* History of active autoimmune disorders, or ongoing immunosuppressive therapy or ongoing .\n* Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to \\\u003C Grade 2.\n* Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A) .\n* Prior treatment with hematopoietic progenitor kinase 1 (HPK1) inhibitors.",{"count":202,"type":21},267,[24,64],"This is a multicenter, open-label study to assess the safety and preliminary efficacy and to determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and recommended Phase 2 doses (RP2D) of PRJ1-3024 in subjects with relapsed\u002Frefractory solid tumors. The study consists of two parts, one is a 3+3 dose escalation study and another is a pharmaceutical extension of RP2D.",[206,27],"Advanced Solid Tumor",[208,209,210,211,212],"Maximum tolerated dose","Recommended Phase 2 dose","Dose Escalation","Hematopoietic progenitor kinase 1","PRJ1-3024","2024-12-11",{"date":215,"type":43},"2024-12-17",{"date":217,"type":43},"2022-05-30",{"date":219,"type":21},"2027-11-15",{"name":221,"class":50},"Zhuhai Yufan Biotechnologies Co., Ltd",5]