[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ranok Therapeutics (Hangzhou) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":117},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,69,92],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100618641","phase-1-a-study-to-evaluate-the-food-effect-on-rnk08954-in-healthy-participants-and-the-mass-balance-study-of-14crnk08954-in-healthy-adult-male-subjects-100618641",false,"NCT07334262","A Study to Evaluate the Food Effect on RNK08954 in Healthy Participants, and the Mass Balance Study of [14C]RNK08954 in Healthy Adult Male Subjects","A Study to Evaluate the Food Effect on the Pharmacokinetics of RNK08954 Tablets and to Assess the Mass Balance of [14C]RNK08954 in Healthy Adult Male Subjects in China","Inclusion Criteria:\n\n* Healthy, adult, male or female, 18-45 years of age, inclusive, at the screening visit.\n* Male participants must have a body weight of no less than 50 kg, and female participants must have a body weight of no less than 45 kg. The Body mass index (BMI) should be between 19 and 26 kg\u002Fm² (inclusive).\n* Must follow protocol specified contraception guidance.\n* Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.\n\nExclusion Criteria:\n\n* Clinically significant abnormalities found in comprehensive physical examinations, vital signs, laboratory tests, 12-lead electrocardiogram, chest X-ray, etc.\n* Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or treponema pallidum antibody.\n* Individuals with allergic constitution.\n* Any history of clinically significant diseases or conditions that, in the investigator's judgment, may affect the trial results.\n* History or family history of organic heart disease, heart failure, myocardial infarction, angina pectoris, torsades de pointes, ventricular tachycardia, QT prolongation syndrome.\n* Gastrointestinal diseases that cause clinically significant symptoms such as nausea, vomiting, diarrhea, or malabsorption syndrome, or those with a history of vomiting or diarrhea within one week prior to screening.\n* Individuals with dysphagia.\n* Undergone major surgery within six months prior to the first dose or whose surgical incision has not fully healed.\n* Used investigational drugs or received other experimental treatments within three months prior to the first dose or are currently participating in any other interventional clinical trials.\n* Vaccinated within one month prior to the first dose or plan to be vaccinated during the trial period.\n* Used any drugs affecting drug-metabolizing enzymes or transporters within 30 days prior to the first dose.\n* Taken any prescription drugs, over-the-counter medications, herbal medicines, or dietary supplements within 14 days prior to the first dose.\n* Smoke more than 10 cigarettes per day or habitually use nicotine-containing products within three months prior to the first dose.\n* Current or previous alcohol abuse, or frequent alcohol consumption within six months prior to the first dose, or those with a positive alcohol breath test.\n* History of drug abuse, use of soft drugs within three months prior to the first dose, or use of hard drugs within one year prior to the first dose, or those with a positive urine drug abuse screening.\n* Individuals who habitually or excessively consume grapefruit juice, tea, coffee, and\u002For caffeinated beverages.\n* History of blood loss or blood donation (≥400 mL) within three months prior to the first dose, those who have received blood transfusions or blood products within one month prior to the first dose, or those who plan to donate blood within three months after the trial.\n* Special dietary requirements, intolerance to high-fat meals, or inability to comply with a standardized diet.\n* History of needle or blood phobia, difficulty with blood collection, or intolerance to venipuncture.\n* Pregnant or lactating women.\n* have poor compliance or other factors that make them unsuitable for participation in this trial.",true,"ALL","18 Years","45 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","An Study of Orally Administered RNK08954 in Healthy Adult Subjects to Determine the Effect of Food on the Pharmacokinetics of RNK08954，Mass Balance Study of \\[14C\\] RNK08954 in Chinese Healthy Adult Male Subjects",[28,29],"Food Effect","Mass Balance","NOT_YET_RECRUITING","2026-01-12",{"date":33,"type":34},"2026-01-14","ACTUAL",{"date":36,"type":22},"2025-12-31",{"date":38,"type":22},"2026-12-01",{"name":40,"class":41},"Ranok Therapeutics (Hangzhou) Co., Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100616273","phase-2-to-evaluate-the-safety-and-efficacy-of-rnk08954-in-patients-with-metastatic-pancreatic-ductal-adenocarcinoma-100616273","NCT07303465","To Evaluate the Safety and Efficacy of RNK08954 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma.","A Study to Evaluate the Efficacy and Safety of RNK08954 in Subjects With KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n* The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.\n* Male and female subjects aged 18-75 years (including 18 and 75 years).\n* Pancreatic ductal adenocarcinoma confirmed by pathology (histology) or cytology.\n* At the time of study enrollment, according to the solid tumor efficacy evaluation criteria (RECIST1.1), imaging diagnosis had at least one measurable lesion .\n* Presence of a KRAS G12D mutation.\n* Physical condition score ECOG score 0-1 points.\n* Expected survival ≥ 12 weeks.\n* Have adequate hematologic and end-organ function, with laboratory test results within required parameters within 7 days prior to the first dose.\n* Fertile female subjects and male subjects whose partners are women of reproductive age must agree to comply with the contraceptive requirement from the time of signing the informed consent until 6 months after the final administration of the trial drug.Fertile female subjects must undergo a serum pregnancy test within 7 days before the first dose, and the result is negative; And must be non-lactating.\n\nExclusion Criteria:\n\n* Diagnosed with other pathological types of pancreatic tumors;\n* Presence of uncontrolled symptomatic central nervous system metastases; including leptomeningeal metastasis, spinal cord metastasis, or brainstem metastasis.\n* Presence of symptomatic, moderate or greater fluid accumulation in serous cavities (e.g., pleural effusion, ascites, pericardial effusion) which either necessitates therapeutic intervention or is judged by the investigator to make the patient ineligible.\n* Clinical condition with an acute and significant decline, including, but not limited to, a decrease in ECOG performance status to \\>1 within 72 hours prior to the baseline visit and initiation of study treatment, a weight loss of ≥10% during the screening period, or a BMI \\\u003C18.0 kg\u002Fm²\n* Except for certain circumstances, a history of malignant tumors other than the inclusion diagnosis within 2 years prior to the first administration of the drug;\n* History of known severe or uncontrolled cardiovascular or cerebrovascular disease that requires treatment.\n* The patient had previously used KRAS inhibitors or pan-KRAS inhibitors therapy.\n* Received systemic anti-tumor therapy prior to the first dose, or received Chinese herbal preparations with clear anti-pancreatic tumor indications within 2 weeks before the first dose.\n* Having received other investigational drugs or therapies not yet approved for marketing prior to the first dose, with the interval from the last administration or treatment being less than 4 weeks or 5 half-lives (whichever is shorter).\n* Having undergone major surgery or experienced significant trauma within 4 weeks prior to the first dose, or requiring elective surgery during the trial period.\n* The presence of severe non-healing wounds, ulcers, fractures, etc., within 4 weeks prior to the first dose.\n* Severe infection occurred within 4 weeks prior to the first dose, including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia; presence of systemic active infection within 2 weeks prior to the first dose requiring systemic anti-infective therapy.\n* Presence of active tuberculosis infection at the time of screening.\n* Positive for hepatitis B surface antigen (HBsAg) at screening with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 2000 IU\u002FmL or 10⁴ copies\u002FmL (however, subjects can be enrolled if their HBV-DNA is \\\u003C2000 IU\u002FmL or 10⁴ copies\u002FmL after antiviral therapy).\n* Positive for hepatitis C antibody (HCV-Ab) and positive for hepatitis C virus (HCV) ribonucleic acid (RNA) at screening.\n* Known infection with human immunodeficiency virus (HIV) or active Treponema pallidum, except under certain circumstances.\n* Presence of any toxicity from previous antitumor therapies that has not recovered to Grade ≤1.\n* Other situations that the researchers believe should not be included.","75 Years",{"count":52,"type":22},60,[54],"PHASE2","This is a multicenter, open-label, phase Ⅱa study to explore the safety, tolerability, and preliminary efficacy of RNK08954 in metastatic pancreatic ductal adenocarcinoma harboring a KRAS G12D mutation.",[57,58],"KRAS G12D Mutations","Pancreatic Ductal Adenocarcinoma (PDAC)","RECRUITING","2025-12-10",{"date":62,"type":34},"2025-12-24",{"date":64,"type":34},"2025-10-14",{"date":66,"type":22},"2026-11-30",{"name":40,"class":41},2,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100567388","phase-1-a-study-of-rnk08954-in-subjects-with-advanced-solid-tumors-with-kras-kirsten-rat-sarcoma-g12d-mutation-100567388","NCT06667544","A Study of RNK08954 in Subjects With Advanced Solid Tumors With KRAS ((Kirsten Rat Sarcoma) G12D Mutation","A Phase 1\u002F2, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of RNK08954 in Patients With Advanced Solid Tumors With a KRAS G12D Mutation TRIAD1 (Trial of RNK08954 In KRAS G12D Mutation)","TRIAD1","Inclusion Criteria:\n\n1. Must be 18 years of age or older.\n2. Must have pathologically documented locally advanced or metastatic malignancy harboring KRAS G12D mutations identified through deoxyribonucleic acid (DNA) sequencing of tumor tissues or circulating deoxyribonucleic acid (ctDNA) performed locally.\n3. Must have received prior standard therapy appropriate for their tumor type, or in the opinion of the investigator, would be unlikely to derive further clinically meaningful benefit from appropriate standard of care therapy.\n4. Must have measurable lesion(s) per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 by Computed tomography (CT) scan with contrast (magnetic resonance imaging (MRI), if the patient is allergic to contrast media).\n\n   * Measurable disease may be in the field of prior irradiation; however, at least 3 weeks must have elapsed between the completion of radiation therapy and the baseline scan documenting disease status.\n   * Bone disease is considered radiologically measurable only if there is at least a 50% lytic component.\n\n   NOTE: Bone disease consisting of only blastic lesion is not considered measurable.\n\n   NOTE: in Phase 1a, patients must have measurable or evaluable disease.\n5. Archival or fresh tumor tissue must be available for evaluating relevant biomarkers. Formalin-fixed paraffin-embedded (FFPE)block preferred, or a minimum of 3 unstained FFPE slides of one archived block is required.\n\n   NOTE: cytology samples from fine needle aspirates or brushing biopsies are not sufficient.\n\n   NOTE: Phase 1a and 1b: Patients are additionally encouraged to undergo pre-treatment tumor biopsy.\n6. Must have adequate performance status, Appendix D.\n\n   o Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0, or 1.\n7. Must be able to take oral medications and willing to record daily adherence to the investigational product.\n8. Must have adequate laboratory parameters at baseline:\n\n   * Absolute neutrophil count ≥ 1.2 x 109\u002FL.\n   * Hemoglobin greater than or equal to (≥) 9 g\u002FdL.\n   * Platelet count ≥ 75 x 109\u002FL.\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to (≤) 2.5 x upper limit of normal (ULN) (≤ 5 x ULN in presence of liver metastases).\n   * Total bilirubin ≤ 1.5 x institutional ULN \\[less than (\\\u003C) 2.5 x ULN for patients with documented Gilbert's syndrome or \\\u003C 3.0 x ULN for patients for whom the indirect bilirubin level suggests an extrahepatic source of elevation\\].\n   * Calculated creatinine clearance greater than (\\>) 60 mL\u002Fmin. Actual body weight should be used for calculating creatinine clearance (e.g. using the Cockcroft-Gault formula).\n\n   For patients with a Body Mass Index (BMI) \\> 30 Kg\u002Fm2, lean body weight should be used instead.\n   * Acceptable coagulation parameters: Fibrinogen ≥ 1.5 g\u002FdL, or partial thromboplastin time (PTT) ≤ 1.5 X institutional ULN, or international normalized ratio (INR) \\\u003C 1.5 X institutional ULN or within target range if a patient is on prophylactic anti-coagulant therapy.\n   * Serum albumin ≥ 3.0 g\u002FdL.\n9. Must have life expectancy of \\> 12 weeks according to the Investigator's clinical judgment.\n10. Females of childbearing potential must have a negative pregnancy test at screening and additional pregnancy test prior to first dose.\n\n    NOTE: Positive pregnancy test may occur in approximately 10% of cancer patients, who are otherwise postmenopausal. This is due to Human Chorionic Gonadotrophin (HCG) secreted by some tumor types such as ovarian or colorectal cancer (CRC), even in postmenopausal women. A quantitative test should be performed in patients with a positive serum pregnancy test, otherwise thought to be postmenopausal.\n11. Males and females of childbearing potential must agree to use a highly effective method of contraception during treatment and for at least 6 months after the last dose of study treatment. These include, but not limited to:\n\n    o Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (i.e. intravaginal or transdermal).\n    * Progestogen-only hormonal contraception associated with inhibition of ovulation (i.e. injectable or implantable).\n    * Intrauterine device.\n    * Bilateral tubal occlusion.\n    * Vasectomized partner.\n    * Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments) is intended. The true abstinence is when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence \\[e.g. calendar, ovulation, symptom-thermal, post-ovulation methods\\] and withdrawal are not acceptable methods of contraception).\n\n    NOTE: A patient is not considered in childbearing potential if any of the following criteria is met:\n    * has had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.\n    * Age ≥ to 60 years and is amenorrhoeic.\n    * Age \\\u003C 60 years and has been amenorrhoeic for ≥12 months (including no irregular menses or spotting) in the absence of any medication which induces a menopausal state and has ovarian failure as indicated by serum estradiol and follicle-stimulating hormone levels.\n\n    NOTE: Male patients will be advised to arrange for the freezing of sperm samples prior to the start of the study, and not to donate sperm until 6 months after discontinuation of study treatment.\n12. Must be able to understand and comply with the conditions of the protocol and must have read and understood the consent form and provided written informed consent.\n\n    Food Effect Assessment- Specific Inclusion Criteria\n13. Must be able to eat a standardized high-fat, high-caloric meal within 30 minutes.\n14. Must be able to fast for a minimum of 10 hours. Phase 1b and Phase 2 Specific inclusion criteria\n15. Patient must have received at least one but no more than two prior lines of systemic cytotoxic chemotherapy in locally advanced or metastatic setting.\n16. The status of KRAS G12D mutations will be performed in a central laboratory chosen by the Sponsor.\n\nExclusion Criteria:\n\nA patient is not eligible to participate in the study if any of the following criteria are met:\n\n1. Concurrent anticancer therapy \\[chemotherapy, monoclonal antibodies, targeted therapy, hormonal therapy or investigational agents\\] within the lesser of 28 days or 5 half-lives before study Day 1.\n\n   NOTE: Patient must agree not to participate in any other interventional clinical studies during their participation in this trial while on study treatment.\n\n   NOTE: patients receiving hormonal ablation therapy for breast cancer or hormone refractory prostate cancer are allowed.\n\n   NOTE: Patients taking part in surveys or observational studies are eligible to participate in this study.\n2. Significant acute decline in clinical status including:\n\n   -Decline in ECOG PS to \\>1 between baseline visit and within 72 hours prior to starting study treatment.\n\n   -Weight loss of ≥10% during screening.\n3. Presence of active or symptomatic untreated central nervous system (CNS) metastases.\n\n   NOTE: Patients with asymptomatic or stable CNS metastases are eligible, provided that the CNS metastases are radiologically and clinically stable for at least 2 weeks prior to enrollment, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).\n4. Unresolved toxicities from prior anticancer therapy, defined as not having resolved according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade ≤ 1, or to levels dictated in the eligibility criteria, with the exception of alopecia.\n\n   NOTE: Grade 2 or 3 toxicities from prior anticancer therapy that are considered irreversible (present and stable for \\>6 months) may be allowed if they are not otherwise described in the exclusion criteria and after a consultation between the Medical Monitor and the Investigator.\n5. Prior radiotherapy to the only area of measurable disease, unless there is documented disease progression.\n\n   NOTE: Patients must have completed treatment and recovered from all acute treatment-related toxicities prior to administration of the first dose of RNK08954.\n6. Presence of gastrointestinal (GI) tract disease causing inability to take oral medication, such as malabsorption syndrome, requirement for intravenous alimentation, uncontrolled inflammatory GI disease, e.g. Crohn's disease or ulcerative colitis, or any other severe acute or chronic condition that may increase the risk of study participation including, e.g. history of abdominal fistula, GI perforation, peptic ulcer.\n7. Current or history within 6 months prior to study enrollment of medically significant cardiovascular disease including symptomatic congestive heart failure \\> New York Heart Association (NYHA) Class II, unstable angina pectoris, clinically significant cardiac arrhythmia, or a history of long QT Syndrome (the heart's electrical activity as graphed on an electrocardiogram) or a family member with this condition.\n\n   NOTE: patients with a marked baseline prolongation of QT\u002FQTc (corrected) interval (e.g. repeated demonstration of a corrected QT (QTc) interval ≥ 470 mSec (one thousandth of a second) will be excluded. A consistent method of QTc calculation must be used for each patient's QTc measurements. QTcF (Fridericia's formula) is preferred.\n8. Use of concomitant medications that have the potential to cause clinically relevant drug-drug interactions with RNK08954; including but not limited to:\n\n   * All herbal medicines (e.g. St John's wort).\n   * Use of strong inhibitors of Polymeric P-glycoprotein) P-gp within two weeks prior to Study Day 1.\n   * Use of strong inducers or inhibitors of Cytochrome P450 3A4 (CYP3A4) within two weeks prior to Study Day 1.\n   * Use of known 3A4, or C member 19 (2C19) sensitive substrates (with a narrow therapeutic window) within two weeks prior to Study Day 1.\n\n   NOTE: other supplemental medicines, vitamins received by the patients within 3 weeks of the study enrollment will be reviewed and acknowledged or approved by the Investigator and the Sponsor Medical Monitor.\n9. Pregnancy or breast-feeding or planning to breast feed during the study or within 6 months after study treatment.\n10. Untreated human immunodeficiency virus (HIV). NOTE: Patients with a known history of HIV infection should have a cluster of differentiation 4 (CD4)+ thymus (T)-cell (CD4+) count ≥ 350 cells\u002FmL to be eligible.\n11. Active infection requiring systemic antibiotics, antiviral or antifungal treatment.\n\n    NOTE: Patient must be medically stable, afebrile, and not taking antimicrobial treatment for ≤ 3 days prior to the first dose of study drug.\n12. Known hepatitis B virus, or Hepatitis C virus:\n\n    * Positive Hepatitis B Surface Antigen (Hep B sAg) (indicative of chronic Hepatitis B), positive Hepatitis total core antibody with negative Hep B sAg (suggestive of occult hepatitis B).\n    * Detectable Hepatitis C virus (HCV) Ribonucleic acid (RNA) by Polymerase chain reaction (PCR) (indicative of active Hepatitis C), or positive Hepatitis C Antibody (Hep C Ab).\n\n    NOTE: testing at screening is not required unless clinically indicated by the Investigator.\n\n    NOTE: Patients with a history of hepatitis B or C are allowed if hepatitis B virus (HBV )DNA or hepatitis C virus (HCV) RNA are undetectable.\n13. Known hypersensitivity to any of the components of the study drug.\n14. Other conditions, psychiatric illness\u002Fsocial situations or any other serious uncontrolled medical disorders in the opinion of the Investigator that would limit compliance with study requirements.\n\nPhase 1b and Phase 2 Specific exclusion criteria 15. History of other malignancies except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated by surgery alone or surgery plus radiotherapy with no evidence of disease for \\>2 years.\n\n16\\. Prior treatment with KRAS G12D or Pan KRAS inhibitor.\n\n\\-",{"count":78,"type":22},152,[25,54],"This is a first in human (FIH), Phase 1\u002F2 open-label multi-center, dose escalation and expansion study to evaluate the safety, tolerability and pharmacokinetics of RNK08954 to determine the optimal dose and recommended dose for expansion and evaluate clinical activity in patients with advanced solid tumors with KRAS G12D mutation.\n\nThis is a 2-part study: dose exploration\u002Findication expansion and dose optimization ( to identify a dose that preserves clinical benefit with optimal tolerability).",[82],"KRAS G12D Mutation","2025-10-28",{"date":85,"type":34},"2025-10-30",{"date":87,"type":34},"2024-11-08",{"date":89,"type":22},"2027-07",{"name":40,"class":41},6,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":23,"phases":101,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},"100476686","phase-1-a-study-of-rnk05047-in-subjects-with-advanced-solid-tumorsdiffuse-large-b-cell-lymphoma-champ-1-100476686","NCT05487170","A Study of RNK05047 in Subjects With Advanced Solid Tumors\u002FDiffuse Large B-cell Lymphoma (CHAMP-1)","A Phase 1\u002F2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Chaperone-mediated Protein Degrader RNK05047 in Subjects With Advanced Solid Tumors (CHAMP-1)","Inclusion Criteria:\n\n* Pathologically documented locally advanced or metastatic solid tumor\n* Refractory or intolerant to all available standard-of-care therapies for advanced disease\n* Measurable disease\n* Archived tumor tissue collected\n* ECOG Performance Status of 0 or 1\n* BMI ≥ 18 kg\u002Fm2\n* Adequate liver, renal, hematologic, and coagulation parameters\n* Negative serum pregnancy test (for women of childbearing potential) at Screening and a negative urine or serum pregnancy test on Day 1 prior to the first infusion\n* Males and females of childbearing potential must agree to use a highly effective method of contraception during treatment and for at least 4 months after the last dose of study treatment.\n* Must be able to understand and comply with the conditions of the protocol and must have read and understood the consent form and provided written informed consent.\n\nExclusion Criteria:\n\n* Concurrent anticancer therapy: Radiotherapy, chemotherapy, biological therapy, or other anticancer investigational agents NOTE: at least 5 half-lives must have been ensued for any prior systemic cancer therapy agent before subject received the study drug on Day 1\n* Unresolved toxicities from prior anticancer therapy, defined as not having resolved according to CTCAE version 5.0 Grade ≤ 1, excluding Grade 1 alopecia\n* Presence or suspicion of active central nervous system (CNS) metastases and\u002For leptomeningeal carcinomatosis\n* Peripheral neurotoxicity ≥ Grade 2 according to CTCAE v5.0\n* Known active infection with HIV, HTLV-1, hepatitis B or C\n* Women who are pregnant or breastfeeding\n* History of another malignancy unless the subject has been treated with curative intent for this malignancy",{"count":100,"type":22},32,[25,54],"This is a first in human, Phase 1\u002F2 open-label multi-center, dose escalation and expansion study to evaluate the safety, tolerability, PK, PD and efficacy of RNK05047 when administered an intravenous (IV) infusion to subjects with advanced solid tumors, including diffuse large B-cell lymphoma (DLBCL).\n\nThis is a 2-part study (dose escalation, cohort expansion) with sequential enrollment.",[104,105],"Advanced Solid Tumor","DLBCL",[107],"protein degrader","2025-02-27",{"date":110,"type":34},"2025-03-04",{"date":112,"type":34},"2022-07-12",{"date":114,"type":22},"2025-09-01",{"name":40,"class":41},5,""]