[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Astellas Pharma Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":111},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,80],{"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":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100617445","phase-1-a-study-of-asp2246-for-people-who-have-movement-problems-caused-by-brain-injury-after-a-stroke-100617445",false,"NCT07318714","A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke","A Phase 1\u002F2 Multicenter, Open-label, Dose Escalation Study Followed by a Randomized, Double-blind Sham-controlled Dose Expansion Study to Evaluate the Safety, Tolerability and Efficacy of ASP2246 in Adult Participants Who Have Motor Dysfunction Associated With Late Subacute to Chronic Ischemic Stroke Due to Supratentorial Perforator Area Infarction","Inclusion Criteria:\n\n* Participant should have had an ischemic cerebral infarction at least 3 months, but not more than 12 months, before signing informed consent. This stroke must be the first-ever stroke for the participant.\n* Participant has current neuromotor dysfunction with a modified Rankin Scale (mRS) score between 2 to 4 at screening.\n* Participant has Fugl-Meyer Assessment (FMA)- upper extremity (UE) score ≥ 20 to ≤ 50 and FMA-lower extremity (LE) score \\\u003C 21 at screening.\n* Participant has supratentorial perforator area infarction (single lacunar infarction or branch-atheromatous disease \\[BAD\\]), as assessed clinically and by magnetic resonance imaging (MRI) at screening.\n* Participant has completed recovery phase rehabilitation after cerebral infarction and spontaneous improvement is not expected during the study period.\n* Participant is willing and physically able to participate in the designated rehabilitation therapy during the study period.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a woma(e)n of childbearing potential (WOCBP)\n  * WOCBP who has a negative urine or serum pregnancy test at screening (Unique to Japan: with a medical interview) and agrees to follow contraceptive guidance from the time of giving informed consent to at least 180 days after surgery.\n* Female participant must not be breastfeeding or lactating starting at screening and for 180 days after surgery.\n* Female participant must not donate ova after undergoing surgery and for 180 days after surgery.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) for a minimum of 180 days after surgery.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for a minimum of 180 days after surgery.\n* Male participant must not donate sperm for a minimum of 180 days after surgery.\n* Participant agrees not to participate in another interventional study (including rehabilitation) while receiving study intervention\u002Fparticipating for up to 52 weeks in the present study.\n* Participant agrees that the use of antiplatelet, oral anticoagulant or nonsteroidal anti-inflammatory drugs (NSAIDs) will be determined by the local medical staff in accordance with the American College of Chest Physicians Clinical Pharmacy 2022 Guidelines and the Japanese Guidelines for the Management of Stroke 2021. The Japanese guidelines specify that no antiplatelet, oral anticoagulant or NSAIDs are to be restarted post-surgery until results of the day 1 head MRI or computerized tomography (CT) are reviewed and restarting medication is deemed safe.\n\nExclusion Criteria:\n\n* Participant has a cerebral infarct volume \\> 3.4 cm\\^3 or \\\u003C 0.37 cm\\^3, as measured by MRI (use of either a central or local reading is acceptable).\n* Participant has a primary intracerebral or intracranial hemorrhage.\n* Participant has a history of central nervous system (CNS) malignancy or a known presence of any malignancy, unless in remission for \\> 5 years. Exception: The participant with basal or squamous cell skin cancer that has been successfully treated will be considered eligible even if they have been in remission for \\\u003C 5 years.\n* Participant had motor dysfunction of mRS \\> 2 before the onset of the stroke (premorbid mRS).\n* Participant has a history of seizures.\n* Participant has apparent contractures impeding joint movement at shoulder, elbow, forearm, wrist, hand, hip, knee or ankle.\n* Participant with spasticity of grade 2 or higher on the modified Ashworth Scale.\n* Participant has any other neurologic, neuromuscular or orthopedic disease that limits motor function.\n* Participant has an active infection.\n* Participant has a history of or current diagnosis of immunodeficiency.\n* Participant has been deemed to have a high risk of recurrent stroke during the study period (e.g., a family history strongly suggestive of hereditary cerebrovascular disease, such as moyamoya disease and cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy).\n* Participant has an uncontrolled systemic illness, including, but not limited to, hypertension (systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 95 mmHg), resistant hypertension (systolic blood pressure \\[BP\\] ≥ 140 mmHg or diastolic BP ≥ 90 mmHg in a participant who is taking 3 or more medications for hypertension), bleeding disorders, hypercoagulability, diabetes, renal, hepatic or cardiac failure, morbid obesity, or uncontrolled sleep apnea.\n* Participant has any positive findings on tests for occult malignancy, unless a nonmalignant etiology is confirmed.\n* Participant has an uncontrolled major psychiatric illness, including depression (Hamilton Score of \\> 14).\n* Participant has a presence of craniectomy (without bone flap replacement) or other contraindication for stereotactic surgery.\n* Participant has signs and symptoms of intracranial herniation or increased intracranial pressure.\n* Participant with a history of, or electrocardiogram (ECG) evidence suggestive of, recent myocardial infarction (within 6 months of surgery), major dysrhythmia, atrial fibrillation or congestive heart failure.\n* Participant has a substance-related and addictive disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders-5 criteria, including drug or alcohol use.\n* Participant has contraindications to MRI or MRI contrast agent(s).\n* Participant has Montreal Cognitive Assessment (MoCA) score \\\u003C 26.\n* Participant has a history of suicide attempt(s), suicidal behavior, or suicidal ideation (indicated by a 'yes' response to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale \\[C-SSRS\\]) within 12 months prior to study enrollment, or who is assessed at screening to be at a significant risk of committing suicide.\n* Participant has a history of using warfarin or direct oral anticoagulant (DOAC). Exception: The participant will be considered eligible if the medication was discontinued at least 6 months prior to study enrollment, and the embolic source has resolved without recurrence.\n* Participant has a history of neuroleptic drug use. Exception: The participant will be considered eligible if they are neuroleptic medication-free for at least 6 months and their psychiatric symptoms remain mild, stable and do not meet the exclusion criteria.\n* Participant has a history of antiepileptic drug use for seizures. Note: For the participant who has used or is using antiepileptic medications for conditions other than seizures, a detailed risk assessment needs to be conducted to determine eligibility.\n* Participant has had botulinum toxin injection, phenol injection, intrathecal baclofen, or any other interventional treatments for spasticity (except bracing and splinting) within the previous 3 months.\n* Participant has present or previous history of participation in a study with ASP2246.\n* Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.\n* Participant has inadequate organ function as indicated by the laboratory values at screening.\n* Participant has any condition that makes the participant unsuitable for study participation.\n* Participant has known or suspected hypersensitivity to ASP2246 or any components of the formulation used.","ALL","18 Years","80 Years",{"count":20,"type":21},84,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study is for adults who have difficulty moving a few months after a stroke. In this study, ASP2246 will be given to people for the first time. This is known as a \"first in human\" study.\n\nThe main aims of the study are to check the safety of ASP2246, how well people tolerate it, and to find suitable doses of ASP2246 to use later in this study and in future studies.\n\nThis study has 2 parts. In Part 1, people will have brain surgery. During the surgery, different small groups of people will receive a lower to a higher dose of ASP2246. Each dose will be given slowly through a special tube to the damaged part of the brain (intracerebral parenchymal infusion). Any medical problems will be recorded at each dose. This is done to find suitable doses to use in Part 2 of the study.\n\nIn Part 2, other different groups of people will undergo the same type of brain surgery. Some people will receive a higher dose of ASP2246, and some people will receive a lower dose of ASP2246. These are the doses from Part 1. Also, another group of people won't be given ASP2246 during brain surgery. This is known as a sham procedure. This is done so neither the people taking part in Part 2, nor the study doctors (apart from the surgeons) know who will be given ASP2246.\n\nAfter brain surgery, people will be observed for about 2 weeks. For people in Part 1, this will take place in the hospital. For people in Part 2, the observation in hospital may be longer or shorter, depending on the results from Part 1. People in both Parts 1 and 2 will have physical therapy for 12 weeks after surgery and continue to have safety checks for about 1 year after their brain surgery.",[28],"Chronic Ischemic Stroke",[30,31,32,33],"Safety","Tolerability","Efficacy","ASP2246","RECRUITING","2026-07-01",{"date":37,"type":38},"2026-07-02","ACTUAL",{"date":40,"type":38},"2026-04-03",{"date":42,"type":21},"2030-02-28",{"name":44,"class":45},"Astellas Pharma Inc","INDUSTRY",4,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100468651","phase-1-a-study-of-asp3082-in-adults-with-advanced-solid-tumors-100468651","NCT05382559","A Study of ASP3082 in Adults With Advanced Solid Tumors","A Phase 1 Study of ASP3082 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation","Inclusion Criteria:\n\n* Participant has locally advanced (unresectable) or metastatic solid tumor malignancy with documented Kirsten rat sarcoma viral oncogene homolog \\[KRAS\\] G12D mutation and has received prior standard therapy and the investigator does not see any further clinical benefit from continuing such targeted therapy, or is ineligible to receive standard approved therapies (no limit to the number of prior treatment regimens).\n* For the ASP3082 monotherapy escalation cohorts, participants with solid tumor malignancies are allowed to be enrolled. Participants with other known KRAS G12 mutations will not be eligible for the study\n* For ASP3082 combination therapy with Nab-P+GEM or FOLFIRINOX or NALRIFOX: Participant must have mPDAC that has not been previously treated with chemotherapy. If a participant received (neo)adjuvant therapy, tumor recurrence or disease progression must have occurred at least 6 months after completing the last dose of the (neo)adjuvant therapy.\n* Participant consents to provide tumor specimen in a tissue block or unstained serial slides or a tumor biopsy (core needle biopsy or excision) obtained after the last interventional treatment, but prior to start of study intervention. Participant also consents to provide a sample for tumor biopsy during the treatment period as indicated in the study protocol. If a participant cannot provide a fresh tissue biopsy sample, the site should consult with the sponsor\u002Fstudy medical monitor.\n* Participant has at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Participant has an ECOG performance status of 0, 1 or 2 for dose escalation, and 0 or 1 for dose expansion.\n* Participant's last dose of prior antineoplastic therapy, including any immunotherapy, was 21 days or 5 half-lives, whichever is shorter, prior to initiation of study intervention administration.\n* Participant has completed any radiotherapy (including stereotactic radiosurgery) at least 14 days prior to the start of study intervention administration. Participants must have recovered from all radiation-related toxicities, not require corticosteroids (NOTE: Physiologic replacement dose of hydrocortisone or its equivalent \\[defined as up to 30 mg per day of hydrocortisone, 2 mg per day of dexamethasone, or up to 10 mg per day of prednisone\\] is permitted), and not have active radiation pneumonitis. A 1-week washout is permitted for palliative radiation (\\\u003C= 2 weeks of radiotherapy) to non-central nervous system disease.\n* Participant's adverse events \\[AEs\\] (excluding alopecia) from prior therapy have improved to grade 1 or baseline within 14 days prior to start of study intervention (or prior to staring SoC chemotherapy, for first line (1L) participants receiving Nab-P+GEM FOLFIRINOX or NALIRIFOX.\n* Participant has adequate organ function as indicated by protocol laboratory value parameters (If a participant has received a recent blood transfusion, the laboratory tests must be obtained \\>= 14 days after any blood transfusion.).\n* Female participant is not pregnant, confirmed by pregnancy test and medical evaluation by interview, and at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP).\n  * WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after study intervention administration.\n  * EU only: For combination therapy with carboplatin, follow contraception guidelines from the time of informed consent through at least 7 months after the final dose of carboplatin.\n  * South Korea only: For combination therapy with oxaliplatin, follow contraception guidelines from the time of informed consent through at least 15 months after the final dose of oxaliplatin. For combination therapy with cisplatin, follow contraception guidelines from the time of informed consent through at least 14 months after the final dose of cisplatin.\n* Female participant must agree not to breastfeed starting at screening and throughout the study period and for 6 months after study intervention administration.\n* Female participant must not donate ova starting at first dose of study intervention and throughout the study period and for 6 months after study intervention administration.\n* Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 3 months after study intervention administration.\n* Male participant must not donate sperm during the treatment period and for 3 months after study intervention administration.\n* South Korea only: For combination therapy with oxaliplatin, follow contraception guidelines from the time of informed consent through at least 12 months after the final dose of oxaliplatin. For combination therapy with cisplatin, follow contraception guidelines from the time of informed consent through at least 11 months after the final dose of cisplatin.\n* Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 3 months after study intervention administration.\n* Participant agrees not to participate in another interventional study while receiving study intervention (Participants who are currently in the follow-up period of an interventional clinical trial are allowed).\n* For ASP3082 Combination Therapy with Pembrolizumab (Cohort G), or Platinum-based Chemotherapy + Pemetrexed +\u002F- Pembrolizumab (Cohort H): Participant must have pathologically documented locally advanced or metastatic (unresectable Stage IIIB-IV) non-small cell lung cancer (NSCLC) (Note: for Cohort H only, the tumor must be non-squamous NSCLC) with KRAS G12D mutation and\n\n  * have received prior platinum-containing chemotherapy (safety lead-in only) or\n  * have never received systemic therapy (up to 1 cycle of SoC pembrolizumab \\[defined as one 21-day cycle of 200 mg\\] in Cohort G and up to 1 cycle of SoC platinum-based chemotherapy ± pembrolizumab \\[defined as one 21-day cycle of 200 mg\\] or pembrolizumab \\[defined as one 21-day cycle of 200 mg\\] in Cohort H is permitted prior to Screening, provided a 21-day washout occurs before C1D1) for locally advanced or metastatic NSCLC with no oncogenic driver mutations. Participants who received adjuvant or neoadjuvant platinum-based chemotherapy and developed recurrent or metastatic disease more than 12 months after completing therapy may be enrolled.\n\nExclusion Criteria:\n\n* Participant has received investigational therapy within 21 days or 5 half-lives, whichever is shorter, prior to start of study intervention.\n* Participant has symptomatic or untreated central nervous system (CNS) metastases. Participants with asymptomatic, treated CNS metastases are eligible.\n* Participant has leptomeningeal disease as a manifestation of the current malignancy.\n* Participant has a prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years, except for local malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, which are allowed.\n* Participant has a known or suspected hypersensitivity to ASP3082 or any components of the formulation used.\n* Participant with active hepatitis B (including acute hepatitis B virus \\[HBV\\] or chronic HBV) or hepatitis C virus \\[HCV\\] (ribonucleic acid \\[RNA\\] detected by qualitative assay). HCV RNA testing is not required in participants with negative HCV antibody testing.\n* Participant has a known history of human immunodeficiency virus \\[HIV\\] infection. No HIV testing is required unless mandated by a local health authority.\n* Participant has had a myocardial infarction or unstable angina within 6 months prior to the start of study intervention, left ventricular ejection fraction (LVEF) \\\u003C 50% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO) or currently has an uncontrolled illness including, but not limited to symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, obligate use of a cardiac pacemaker, or long QT syndrome.\n* Participant has a corrected QT interval (single electrocardiogram \\[ECG\\]) using Fridericia's formula (QTcF) \\> 450 milliseconds (msec) (men) or \\>470 msec (women) during screening.\n* Participant has received prior treatment with a specific KRAS G12D inhibitor\u002Fdegrader or pan-RAS inhibitor\u002Fdegrader targeting KRAS G12D. Participants who received prior treatment with a KRAS G12D inhibitor\u002Fdegrader are eligible for the ASP3082 combination therapy cohort.\n* Participant has an active infection requiring intravenous antibiotics within 14 days prior to study intervention.\n* Participant is expected to require another form of antineoplastic therapy while on study treatment.\n* Participant has any condition which makes the participant unsuitable for study participation (such as psychiatric illness\u002Fsocial situations that would limit compliance with study requirements).\n* Participant has had major surgery within 4 weeks prior to first dose of study intervention.\n\nFor ASP3082 Combination Therapy:\n\n* Prior discontinuation of cetuximab treatment due to toxicity or intolerance of cetuximab.\n* History of interstitial lung disease requiring systemic steroid treatment. Note that a participant with resolved pulmonary infections or radiation pneumonitis is eligible.",{"count":55,"type":21},681,[24],"This is an open-label study. This means that people in this study and clinic staff will know that people will receive ASP3082. The study aims to check how safe and well-tolerated ASP3082 is for people with advanced solid tumors that have a specific mutation called KRAS G12D.\n\nThis study will be in 2 parts.\n\nIn Part 1, different small groups of people will receive lower to higher doses of ASP3082 by itself, or together with cetuximab. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP3082, by itself or together with cetuximab, to use in Part 2 of the study. The first group will receive the lowest dose of ASP3082. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP3082. The panel will do this for each group until all groups have received ASP3082 (by itself or together with cetuximab) or until suitable doses have been selected for Part 2.\n\nIn Part 2, ASP3082 will be given in by itself, or in combination with the other study treatments.\n\nStudy treatments will be given through a vein. This is called an infusion. Each treatment cycle is 21 or 28 days long. They will continue treatment until: they have medical problems from the treatment they can't tolerate; their cancer gets worse; they start other cancer treatment; or they ask to stop treatment.",[59],"Solid Tumor",[59,61,62,63,64,65,66,67,68,69,70],"Cancer","Malignancy","Metastasis","Pharmacokinetics","setidegrasib","ASP3082","KRAS G12D","NSCLC","CRC","PDAC","2026-06-29",{"date":73,"type":38},"2026-06-30",{"date":75,"type":38},"2022-06-08",{"date":77,"type":21},"2028-12-31",{"name":44,"class":45},55,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},"100600185","phase-1-a-study-to-find-a-suitable-dose-of-asp5834-in-adults-with-solid-tumors-100600185","NCT07094204","A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors","A Phase 1 Study of ASP5834 in Participants With Locally Advanced (Unresectable) or Metastatic Solid Tumor Malignancies With KRAS Mutations or KRAS Amplifications","Inclusion Criteria:\n\n* Participant has histologically confirmed locally advanced (unresectable) or metastatic solid tumor malignancy with a documented Kirsten rat sarcoma viral oncogene homolog (KRAS) G12V, G12D, G12C, G12R, G12A or G13D mutation or KRAS amplification (copy number \\>\u002F= 4) determined by local testing.\n\n  * For a participant with a documented KRAS amplification, only those with no other co-occurring KRAS mutation or those with a co-occurring KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation are eligible.\n  * Unique to Europe (EU): Only participants who have pre-existing local results can be enrolled.\n* For the ASP5834 monotherapy dose escalation part, participant with any histologically confirmed locally advanced (unresectable) or metastatic solid tumor malignancy is eligible. Participant must have received prior standard therapy in the advanced setting, and the investigator does not see any further clinical benefit from continuing such therapy or the participant is ineligible to receive standard approved therapies.\n* For the ASP5834 monotherapy dose expansion part, the following criteria apply:\n\n  * \\[pancreatic ductal adenocarcinoma (PDAC) Expansion Cohort(s)\\] Participant has histologically confirmed locally advanced (unresectable) or metastatic PDAC.\n  * \\[PDAC Expansion Cohort(s)\\] Participant has a documented KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation determined by local testing.\n  * \\[PDAC Expansion Cohort(s)\\] Participant must have received standard therapy in the advanced setting, including prior therapy with a gemcitabine-based or fluoropyrimidine-based regimen or is ineligible for these therapies.\n  * \\[PDAC Expansion Cohort(s)\\] No more than 2 prior lines of systemic therapy are allowed in the advanced setting (note: maintenance therapy does not count as a separate line of therapy).\n  * \\[PDAC Expansion Cohort(s)\\] For a participant who received prior neoadjuvant or adjuvant chemotherapy and had recurrence on or within 6 months of completion of therapy, the neoadjuvant or adjuvant chemotherapy should be counted as a regimen in the advanced setting.\n  * \\[non-small cell lung cancer (NSCLC) Expansion Cohort(s)\\] Participant has histologically confirmed locally advanced (unresectable) or metastatic NSCLC.\n  * \\[NSCLC Expansion Cohort(s)\\] Participant has a documented KRAS G12V, G12D, G12R, G12A or G13D mutation determined by local testing.\n  * \\[NSCLC Expansion Cohort(s)\\] Participant must have received standard therapy in the advanced setting, including prior platinum-based chemotherapy and checkpoint inhibitor therapy or is ineligible for these therapies. Participants with known actionable genomic alterations (AGA) must have received prior therapy with an approved targeted therapy in accordance with local requirements.\n  * \\[NSCLC Expansion Cohort(s)\\] For a participant who has received prior neoadjuvant or adjuvant therapy and had recurrence during or within 6 months of completion of therapy, the neoadjuvant or adjuvant therapy should be counted as a regimen in the advanced setting (for those who received perioperative therapy, the entire course should be counted as therapy in the advanced setting).\n  * \\[NSCLC Expansion Cohort(s)\\] For a participant with a history of unresectable Stage III disease who received prior multi-modal therapy and had recurrence on or within 6 months of completion of therapy, the multi-modal therapy should be counted as a therapy in the advanced setting. If chemoradiation was followed by treatment with checkpoint inhibitor therapy without documented progression between chemoradiation and checkpoint inhibitor therapy, the entire treatment course should be counted as therapy in the advanced setting.\n  * \\[Other Solid Tumor Expansion Cohort\\] Participant has a histologically confirmed locally advanced (unresectable) or metastatic solid tumor type other than PDAC, colorectal cancer (CRC) or NSCLC.\n  * \\[Other Solid Tumor Expansion Cohort\\] Participant has a documented KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation or KRAS amplification (copy number \\>\u002F=4) determined by local testing.\n  * \\[Other Solid Tumor Expansion Cohort\\] Participant must have received prior standard therapy in the advanced setting, and the investigator does not see any further clinical benefit from continuing such therapy or is ineligible to receive standard approved therapies.\n* For ASP5834 combination therapy dose escalation and dose expansion parts, the following criteria apply:\n\n  * \\[CRC Dose Escalation and Dose Expansion Parts\\] Participant has histologically confirmed locally advanced (unresectable) or metastatic adenocarcinoma of the colon or rectum.\n  * \\[CRC Dose Escalation and Dose Expansion Parts\\] Participant has a documented KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation determined by local testing.\n  * \\[CRC Dose Escalation and Dose Expansion Parts\\] Participant must have received standard therapy in the advanced setting, including prior therapy with fluoropyrimidine, oxaliplatin and irinotecan and anti-vascular endothelial growth factor (VEGF) therapy or is ineligible for these therapies.\n  * \\[CRC Dose Escalation and Dose Expansion Parts\\] For a participant who has received neoadjuvant or adjuvant chemotherapy and had recurrence during or within 6 months of completion of therapy, the neoadjuvant or adjuvant chemotherapy should be counted as a regimen in the advanced setting.\n  * \\[CRC Dose Escalation and Dose Expansion Parts\\] Participant with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) must have also received prior treatment with immune checkpoint inhibitors or is ineligible for these therapies.\n* Participant consents to provide tumor specimen in a tissue block or unstained serial slides or a baseline tumor biopsy obtained after the last interventional treatment, but not more than 90 days prior to the start of study intervention. Participant also consents to provide a tumor biopsy during the treatment period as indicated in the schedules of assessments. If a participant cannot provide a tumor specimen or undergo a baseline tumor biopsy procedure no more than 90 days prior to the start of study intervention, contact the medical monitor. Submission of an archival tumor tissue specimen to the central laboratory in addition to the baseline specimen is highly encouraged.\n* Participant has at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participant's adverse event (AEs) (excluding alopecia) from prior anti-cancer therapy have improved to Grade 1 or baseline at least 14 days prior to the start of study intervention. Persistent Grade 2 or higher toxicities from prior anti-cancer therapy that are considered clinically irreversible, may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and sponsor.\n* Participant has adequate organ function as indicated by laboratory values (if a participant has received a recent blood transfusion, the laboratory tests must be obtained \\>\u002F= 14 days after any blood transfusion).\n* Female participant is not pregnant confirmed by pregnancy test and medical evaluation by interview, and at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP)\n  * WOCBP who has a negative urine or serum pregnancy test within 7 days prior to day 1 and agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final investigational study intervention administration.\n* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 6 months after final investigational study intervention administration.\n* Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 6 months after final investigational study intervention administration.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 3 months after final investigational study intervention administration.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 3 months after final investigational study intervention administration.\n* Male participant must not donate sperm during the treatment period and for 3 months after final investigational study intervention administration.\n* Participant agrees not to participate in another interventional study while receiving study intervention in the present study\u002Fparticipating in the present study.\n\nExclusion Criteria:\n\n* Participant has symptomatic or untreated central nervous system (CNS) metastases. Participants with stable, asymptomatic and treated CNS metastases are eligible.\n* Participant has leptomeningeal disease as a manifestation of the current malignancy.\n* Participant has another prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years different from the primary malignancy for this study, except for local malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, which are allowed.\n* Participant with active hepatitis B (including acute hepatitis B virus (HBV) or chronic HBV) or hepatitis C virus (HCV) (Ribonucleic acid (RNA) detected by qualitative assay). HCV RNA testing is not required in participants with negative HCV antibody testing.\n* Participant has a known history of human immunodeficiency virus (HIV) infection with Acquired Immune Deficiency Syndrome (AIDS) related complications. No HIV testing is required unless mandated by a local health authority.\n* Participant has had a myocardial infarction or unstable angina within 6 months prior to the start of study intervention or currently has an uncontrolled illness including, but not limited to symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia (including but not limited to uncontrolled atrial fibrillation, recent restoration of rhythm after atrial fibrillation, clinically significant conduction disorder within 6 months prior to the start of study intervention, or ventricular arrhythmias), obligate use of a cardiac pacemaker, or long QT syndrome.\n* Resting heart rate \\\u003C 50 bpm at screening, unless clinically appropriate (e.g., well-conditioned participant) and deemed not clinically significant.\n* Known family history of sudden cardiac death before 50 years of age.\n* Hypokalemia that is not corrected to within the institutional normal range prior to first dose of study intervention.\n* Participants with clinically significant electrolyte abnormalities (e.g., hypomagnesemia or hypocalcemia) that are not corrected to within the institutional normal range prior to first dose of study intervention.\n* Participant has had major surgery within 4 weeks prior to first dose of study intervention.\n* Participant has acute neurological events (e.g., intracranial or subarachnoid hemorrhage, stroke, intracranial trauma) within 6 months prior to the first dose of study intervention.\n* Participant has received any radiotherapy (including stereotactic radiosurgery) within 14 days prior to the first dose of study intervention.\n* Participant has received prior KRAS targeting agents (including but not limited to KRAS directed inhibitors, degraders, small interfering RNA \\[siRNA\\] therapies, vaccines and cellular therapies), with the following exceptions:\n\n  * In the dose escalation part, a participant with PDAC or NSCLC who has received prior RMC-6236 or RMC-9805 or a participant with NSCLC who has received prior KRAS G12C inhibitors but no other KRAS targeting agents will be eligible.\n* Participant has an active infection requiring any systemic anti-infectious agents within 14 days prior to study intervention.\n* Participant is expected to require another form of anticancer therapy while on study treatment.\n* Participant requires treatment with concomitant drugs that are strong or moderate inhibitors or inducers of Cytochrome P450 family 3 subfamily A (CYP3A).\n* Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.\n* Participant has any condition that makes the participant unsuitable for study participation.\n* Participant has a known or suspected hypersensitivity to the protocol specified study intervention(s) or any components of the formulation used.\n* Participant has a corrected QT interval by Fridericia (QTcF) value (single electrocardiogram (ECG)) of \\> 450 msec (men) or \\> 470 msec (women) during screening.\n* Participant has a left ventricular ejection fraction (LVEF) \\\u003C 50% as assessed by echocardiogram (ECHO) (or multigated acquisition (MUGA)) performed at screening.\n* Participant with a known history of an acquired KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation or KRAS amplification identified as a resistance mechanism to prior systemic therapy (note: if a participant has more than 1 relevant KRAS alteration \\[KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation or KRAS amplification\\], only those with a known history of acquired resistance to all relevant KRAS alterations would be excluded). Participant will not be excluded if it is not known whether the KRAS alteration(s) were acquired as a resistance mechanism.\n* UNIQUE to EU: Participant who is the subject of any legal protection measures under local legislation will not be allowed.\n* Participant has a history of pneumonitis\u002Finterstitial lung disease (ILD) or has current pneumonitis\u002FILD. Note that a participant with resolved pulmonary infections is eligible.\n* \\[ASP5834 combination therapy\\] Participant had prior discontinuation of panitumumab treatment due to toxicity or intolerance of panitumumab.",{"count":88,"type":21},364,[24],"Genes contain genetic code which tell the body which proteins to make. Many types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene.\n\nASP5834 is being studied in people with solid tumors who have certain KRAS gene mutations. Some people with solid tumors of the colon or rectum (colorectal cancer), will be given ASP5834 with panitumumab. Panitumumab is a treatment for colorectal cancer. In this study, the researchers will learn how ASP5834 is processed by and acts upon the body. This information will help find a suitable dose of ASP5834 and check for any potential medical problems from the treatment.\n\nThe main aims of this study are to check the safety of ASP5834 given by itself or given with panitumumab, and how well it is tolerated; and to find a suitable dose of ASP5834 given by itself or given with panitumumab.\n\nPeople in this study will be adults with locally advanced, unresectable, or metastatic solid tumors with certain KRAS gene mutations. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. They either haven't responded to standard treatment or couldn't be given standard treatment. The key reasons people cannot take part are if they have specific uncontrollable cancers such as symptomatic or untreated cancers in nervous system, have specific heart conditions, swelling and irritation of lung tissues (pneumonitis or interstitial lung disease, also called ILD), infections, or have recently had a stroke or a bleed on the brain.\n\nIn this study, ASP5834 is being given to humans for the first time. This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP5834 by itself or ASP5834 with panitumumab.\n\nThis study will be in 2 parts:\n\nPart 1 is called Dose Escalation. Different small groups of people will receive lower to higher doses of either: ASP5834 by itself or ASP5834 with panitumumab. Only people who have colorectal cancer will receive ASP5834 with panitumumab. People with any type of solid tumor will receive ASP5834 by itself. For each dose, all medical problems will be recorded. A medical expert panel will check the results and decide if the next group can receive a higher dose of ASP5834. The panel will do this until the planned maximum number of people are treated or until suitable doses have been selected for Part 2.\n\nPart 2 is called Dose Expansion. Other different small groups of people will receive ASP5834 or ASP5834 with panitumumab. They will receive the most suitable doses worked out from Part 1.\n\nIn both parts of the study, the study treatments ASP5834 and panitumumab will be given through a vein. This is called an infusion. Each study treatment cycle is either 21 days or 28 days long. People will continue study treatment until: they have medical problems from the study treatment they can't tolerate; their cancer gets worse; they start other cancer treatment; or they ask to stop study treatment.\n\nPeople will visit the clinic on certain days during their study treatment, with extra visits during the first 2 cycles of study treatment. The study doctors will check for any medical problems from ASP5834. Also, people in the study will have a health check. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken at certain visits during study treatment with the option of a tumor sample being taken if people's cancer gets worse or the cancer comes back.\n\nPeople will visit the clinic shortly after stopping treatment for a health check. After this, people will have health checks every couple of months to check the condition of their cancer. The number of visits and checks done will depend on the health of each person and whether they completed their study treatment or not. It is expected that people will be in this study for about 1 year.",[59,92,93,94],"Non-Small-Cell Lung Cancer","Pancreatic Ductal Adenocarcinoma","Colorectal Cancer",[59,61,62,63,64,96,97,67,98,99,100,101,69,68,70],"ASP5834","KRAS G12V","KRAS G12C","KRAS G12R","KRAS G12A","KRAS G13D","2026-05-15",{"date":104,"type":38},"2026-05-18",{"date":106,"type":38},"2025-07-25",{"date":108,"type":21},"2029-04-30",{"name":44,"class":45},20,""]