[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-pancreatic-ductal-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-pancreatic-ductal-adenocarcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,74,106,144],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100642767","phase-1-testing-the-combination-of-anti-cancer-drugs-selumetinib-and-ds-8201a-for-advanced-pancreatic-ductal-adenocarcinoma-100642767",false,"NCT07619521","Testing the Combination of Anti-Cancer Drugs, Selumetinib and DS-8201a, for Advanced Pancreatic Ductal Adenocarcinoma","Phase I\u002FII Study of the MEK Inhibitor Selumetinib Plus DS-8201a in KRAS-Mutant, HER2-Expressing Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n* Review of eligibility criteria by the study principal investigator (PI) is required prior to enrollment\n* Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas\n* Patients must have unresectable or metastatic disease with KRAS mutation per Next Generation Sequencing (NGS) tumor testing and HER2 immunohistochemistry (IHC) positivity (2+ or above for dose escalation and per decision rule for phase II), as determined by a Clinical Laboratory Improvement Act (CLIA)-certified kit using gastric cancer criteria\n* Patients must have measurable disease that can fulfill Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria\n* Patients must have exposure to at least one line of systemic chemotherapy for metastatic or unresectable PDAC (for both escalation and phase II cohorts) or a documented patient decision to forego therapy that has an otherwise proven survival advantage (for escalation cohort only)\n* Patients who have received prior topoisomerase inhibitors including irinotecan and nanoliposomal irinotecan will be eligible for this study\n* Only 1 prior line of therapy for metastatic or unresectable PDAC will be allowed for patients in the phase II cohort. Adjuvant or neoadjuvant therapy does not count, assuming it was completed \\> 6 months prior to the start of systemic therapy for metastatic or unresectable disease\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of selumetinib (AZD6244 hydrogen sulfate) in combination with DS-8201a in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 70%). Regardless of performance status, enrollment should be based on the judgment of the treating physician that the patient will be able to be safely treated with the proposed therapeutic intervention\n* Hemoglobin ≥ 9 g\u002FdL (within 14 days of enrollment)\n\n  * No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment\n* Leukocytes ≥ 3,000\u002FmcL (within 14 days of enrollment)\n* Absolute neutrophil count ≥ 1,500\u002FmcL (within 14 days of enrollment)\n\n  * No administration of granulocyte colony-stimulating factor (G-CSF) is allowed within 1 week prior to screening assessment\n* Platelets ≥ 100,000\u002FmcL (within 14 days of enrollment)\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN), (\\\u003C 3 × ULN in the presence of documented Gilbert's syndrome or liver metastases at baseline) (within 14 days of enrollment)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) \\\u003C 5 × ULN in participants with liver metastases (within 14 days of enrollment)\n* Serum albumin ≥ 2.5 g\u002FdL (within 14 days of enrollment)\n* International Normalized Ratio (INR)\u002FProthrombin Time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (within 14 days of enrollment)\n* Creatine phosphokinase (CPK) ≤ 2.5 × ULN (within 14 days of enrollment)\n* Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 (within 14 days of enrollment)\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging, performed at least 6 months after central nervous system (CNS)-directed therapy, shows no evidence of progression\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must undergo a clinical risk assessment of cardiac function using the New York Heart Association (NYHA) Functional Classification. To be eligible, patients must be NYHA Class II or better and have no history of myocardial infarction within 6 months prior to enrollment, no symptomatic congestive heart failure (NYHA Class IIb-IV), and no troponin levels consistent with myocardial infarction (as defined by the manufacturer) within 28 days prior to enrollment\n* Patients must have a baseline left ventricular ejection fraction (LVEF) ≥ 50% as measured by echocardiogram (ECHO) or mutilated acquisition scan (MUGA) scan within 28 days before randomization\u002Fenrollment\n* Patients must be willing to undergo baseline ophthalmic evaluation, including visual acuity and slit-lamp examination\n* The effects of selumetinib (AZD6244 hydrogen sulfate) and DS-8201a on the developing human fetus are unknown. For this reason and because MEK inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 months (for WOCBP) or 4 months (for men) after completion of drug administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Women of non-child-bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases, a blood sample with simultaneous follicle-stimulating hormone \\[FSH\\] \\> 40 mIU\u002FmL and estradiol \\\u003C 40 pg\u002FmL \\[\\\u003C 147 pmol\u002FL\\] is confirmatory) are eligible. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method\n* Male subjects must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration. Preservation of sperm should be considered prior to enrolment in this study\n* Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients with prior MEK inhibitor, ERK inhibitor, or HER2-directed therapy treatment\n* Patients who have had chemotherapy (including antibody drug therapy, retinoid therapy, hormonal therapy for cancer) within 3 weeks (2 weeks or five half-lives, whichever is longer for small-molecule targeted agents such as 5-fluorouracil-based agents, folinate agents), weekly paclitaxel; 6 weeks for nitrosoureas or mitomycin C\n* Patients who have had immunotherapy including monoclonal antibody therapy within 4 weeks\n* Patients who have a history of severe hypersensitivity reactions to other monoclonal antibodies\n* Patients who have had a major surgery within 4 weeks\n* Patients with a history of allogeneic organ or stem cell transplant\n* Patients who are receiving any other investigational agents or received any other investigational agents within the past 21 days prior to protocol treatment initiation\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to selumetinib (ADZ6244 hydrogen sulfate) or DS-8201a\n* Current use or anticipated need for alternative, holistic, naturopathic, or botanical formulations used for the purpose of cancer treatment\n* Patients with prior use of immunosuppressive medication within 14 days prior to first study dose, except for intranasal and inhaled corticosteroids or systemic corticosteroids at doses less than 10 mg\u002Fday of prednisone or equivalent\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Patients with a corrected QT interval (QTc) prolongation to \\> 470 ms (females) or \\> 450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG)\n* Patients with a history of (non-infectious) interstitial lung disease (ILD) that required steroids, presence of ILD that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity, or where suspected ILD cannot be ruled out by imaging at screening. These patients will be excluded because DS-8201a is known to increase the risk of developing ILD and pneumonitis\n* Patients with lung-specific, intercurrent, clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months prior to study enrollment, severe asthma, severe chronic obstructive pulmonary disorder (COPD), restrictive lung disease, significant pleural effusion, etc.), and any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), and\u002For prior pneumonectomy. These patients will be excluded because DS-8201a is known to increase the risk of developing ILD and pneumonitis\n* Patients with gastrointestinal conditions which could impair absorption of selumetinib (AZD6244 hydrogen sulfate) or inability to ingest selumetinib (AZD6244 hydrogen sulfate)\n* Patients with a history of significant retinal pathology (including but not limited to, retinal vein occlusion, retinal detachment, or macular degeneration) or clinically significant ophthalmic abnormalities that may increase the risk of retinal adverse events\n* Active ocular disease requiring systemic therapy or current use of contact lenses that may interfere with ophthalmic evaluations\n* Based on pre-clinical and clinical data, DS-8201a and selumetinib (AZD6244 hydrogen sulfate) are associated with ocular toxicity. Patients with clinically significant corneal disease, in the opinion of the investigator, will be excluded from this study\n* Patients who have had chest radiation therapy within 4 weeks (2 weeks for palliative stereotactic body radiation therapy). These patients will be excluded because DS-8201a is known to increase the risk of developing pneumonitis\n* Patients with spinal cord compression, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms\n* Patients with an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals\n* Patients that have received a live vaccine within 30 days prior to the first dose of study drug will be excluded. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed\n* Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia or peripheral neuropathy) not yet resolved to grade ≤ 1 or baseline. Subjects with chronic grade 2 toxicities may be eligible per the discretion of the Investigator after consultation with the Sponsor Medical Monitor or designee (e.g., grade 2 chemotherapy-induced neuropathy). Subjects should no longer be symptomatic nor require treatment with corticosteroids or anticonvulsants and must have recovered from the acute toxic effect of radiotherapy\n* Patients with ongoing muscle disorders or elevated baseline creatine phosphokinase (CPK) levels suggestive of rhabdomyolysis or myopathy\n* Patients currently using high-dose vitamin E supplements exceeding the recommended daily intake (≥ 400 IU\u002Fday) or concurrent use of anticoagulants\u002Fantiplatelets that may increase bleeding risk, unless clinically indicated and closely monitored\n* Pregnant women are excluded from this study because selumetinib (AZD6244 hydrogen sulfate) is a MEK inhibitor agent with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative pregnancy test within 7 days of study entry. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with selumetinib (AZD6244 hydrogen sulfate) breastfeeding should be discontinued if the mother is treated with selumetinib (AZD6244 hydrogen sulfate). These potential risks also apply to treatment with DS-8201a\n* Patients who have received prior systemic anticancer therapy, investigational agents, or radiotherapy without completion of an adequate washout period prior to study treatment initiation defined as at least 14 days or \\> 5 half-lives of the prior agent (whichever is shorter). This applies to therapies with potential overlapping toxicities with DS-8201a or selumetinib (AZD6244 hydrogen sulfate) including but not limited to agents associated with pulmonary toxicity, cytopenias, or gastrointestinal toxicity","ALL","18 Years",{"count":19,"type":20},31,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This phase I\u002FII trial tests the safety, side effects, best dose and how well giving selumetinib with DS-8201a works for the treatment of pancreatic ductal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic). Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. DS-8201a is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them. Giving selumetinib with DS-8201a may be safe, tolerable and\u002For effective in treating patients with advanced, unresectable or metastatic pancreatic ductal adenocarcinoma.",[27,28,29,30,31],"Advanced Pancreatic Ductal Adenocarcinoma","Metastatic Pancreatic Ductal Adenocarcinoma","Stage III Pancreatic Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","Unresectable Pancreatic Ductal Adenocarcinoma","NOT_YET_RECRUITING","2026-06-10",{"date":35,"type":36},"2026-06-11","ACTUAL",{"date":38,"type":20},"2026-09-08",{"date":40,"type":20},"2026-10-30",{"name":42,"class":43},"National Cancer Institute (NCI)","NIH",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100594562","phase-1-evaluate-the-safety-tolerability-pharmacokinetics-and-efficacy-of-bl-m05d1-in-subjects-with-solid-tumors-100594562","NCT07021066","Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors","A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Signed the informed consent form voluntarily and agreed to follow the program requirements\n2. Age: ≥18 years\n3. Has a life expectancy of ≥3 months\n4. Has documented locally advanced or metastatic solid tumor(s) that are known to potentially express CLDN18.2 as defined below that have recurred or progressed on at least 1 line of prior systemic therapy (including adjuvant\u002Fneoadjuvant), have no other standard of care options, and have no available curative options, including:\n\n   1. Gastric or gastroesophageal junction (G\u002FGEJ) adenocarcinoma (AC): Subjects with CLDN18.2, human epidermal growth factor receptor 2 (HER2), PD-L1 and\u002For microsatellite instability high (MSI-H)\u002F mismatch repair deficiency (dMMR) positive tumors must have received targeted treatment in their prior lines of therapy.\n   2. Pancreatic ductal AC (PDAC): Subjects may enter screening prior to completing the first line of standard therapy.\n   3. Esophageal AC (EAC): Subjects with HER2, PD-L1 and\u002For MSI-H\u002FdMMR positive tumors must have received targeted treatment in their prior lines of therapy.\n   4. Biliary tract cancers (BTCs): Subjects with HER2 overexpression, NTRK fusions, KRAS mutations, IDH1 mutations, FGFR2 fusions, BRAF mutations and\u002For MSI-H\u002FdMMR positive tumors must have received targeted treatment in their prior lines of therapy.\n   5. Other solid tumors not specified above may be included IF they have documented CLDN18.2 expression by IHC (1+). As applicable per standard of care, subjects with HER2 and\u002For PD-L1 positive tumors must have received targeted treatment in their prior lines of therapy, and subjects with MSI-H or dMMR positive tumors must have received immune checkpoint inhibitor.\n5. Agree to provide most recent existing tumor samples (formalin-fixed paraffin-embedded \\[FFPE\\] tissue block or slides) from primary or metastatic sites (see details in Section 7.1.1) for tissue-based evaluation of CLDN18.2 expression. A fresh biopsy is required if no archival\u002FFFPE block or slides are available. Re-biopsy is recommended if the subject previously received a CLDN18.2-directed treatment.\n6. Has at least one measurable lesion based on RECIST (Response Evaluation Criteria in Solid Tumors) v1.1\n7. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1\n8. Toxicity of previous antitumor therapy has returned to Grade ≤1 as defined by the National Cancer Institute (NCI) CTCAE v5.0, except for alopecia and endocrinopathies controlled by replacement therapy that must be Grade ≤2\n9. Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50%\n10. Has adequate organ function before enrollment, defined as:\n\n    1. Marrow function: Absolute neutrophil count (ANC) ≥1.5×109\u002FL, platelet count (PLT) ≥100×109\u002FL, hemoglobin (Hb) ≥9.0 g\u002FdL (blood transfusion, platelet transfusion, erythropoietin, hematopoiesis agents, and granulocyte-colony stimulating factor \\[G-CSF\\] use are not allowed 1 week prior to screening)\n    2. Hepatic function: Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) (≤3×ULN for subjects with Gilbert's syndrome or liver metastasis at baseline), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) without liver metastasis ≤3.0×ULN, AST and ALT with liver metastasis ≤5.0×ULN NOTE: For patients with Gilbert's syndrome, conjugated bilirubin ≤1.5×ULN and TBIL \\\u003C3.0×ULN in the absence of liver metastases.\n    3. Renal function: Creatinine (Cr) clearance ≥60 mL\u002Fmin (Cockcroft-Gault equation) or estimated glomerular filtration rate (eGFR) ≥50 mL\u002Fmin\u002F1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n11. Coagulation parameters: International normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (aPTT) ≤1.5×ULN, unless receiving anticoagulation therapy with prothrombin time and aPTT levels within the intended therapeutic range\n12. Urine protein ≤2+ or ≤1000 mg\u002F24 hours\n13. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception (defined in Appendix E) during the course of the study and after the last dose of study treatment (7 months for women and 4 months for men). An additional contraceptive method, such as a barrier method (eg, condom), is recommended.\n14. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and must be nonlactating. Female subjects are considered WOCBP unless one of the following criteria are met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\>45 years old in the absence of other biological or physiological causes. In addition, females \\\u003C55 years old must have a serum follicle stimulating hormone (FSH) level \\>40 mIU\u002FmL to confirm menopause.\n\nNote: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n\nExclusion Criteria:\n\n1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration\n2. Subjects with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE v5.0), New York Heart Association (NYHA) ≥ Grade 2 heart failure at any time, or history of myocardial infarction or unstable angina pectoris within 6 months before enrollment\n3. Subjects with prolonged QT interval corrected (\\[QTcF\\] \\>470 msec), complete left bundle branch block, Grade 3 atrioventricular block\n4. Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc. Subjects with well-controlled type 1 diabetes, hypothyroidism, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis) are permitted. For autoimmune conditions that are active but stable and low grade on systemic therapy, discussion with the medical monitor is required prior to screening\n5. Subjects with other prior malignancies except for: basal cell carcinoma of the skin, squamous cell carcinoma of the skin and\u002For carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years prior to screening\n6. Subjects with poorly controlled hypertension by two types of antihypertensive drugs (systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>100 mmHg)\n7. Subjects with advanced or clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease and asthma, restrictive lung disease, pulmonary hypertension, etc.\n8. Subjects who have a history of noninfectious interstitial lung disease (ILD)\u002F pneumonitis that required treatment with steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n9. Subjects with stroke or transient ischemic attack (TIA) within 6 months before enrollment\n10. Subjects with a thromboembolic event (eg, deep vein thrombosis \\[DVT\\] or pulmonary embolism \\[PE\\]) within 6 months before enrollment except for those who are clinically stable and receiving treatment with adequate anticoagulant therapy for at least 3 weeks before enrollment\n11. Subjects with primary tumors in the central nervous system (CNS) and active or untreated CNS metastases and\u002For carcinomatous meningitis should be excluded. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to dosing with the investigational product (IP). Patients on low dose corticosteroids (\\\u003C20 mg prednisone or equivalent\u002Fday) may participate.\n12. Subjects with pre-existing Grade ≥2 peripheral neuropathy\n13. Subjects who have a history of anaphylaxis or severe hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of BL-M05D1\n14. Subjects who are receiving treatment with systemic glucocorticoids \\>10 mg\u002Fday equivalent of prednisone, except for the treatment of chronic obstructive pulmonary disease, antiemetic, infusion reactions; however, treatment with low dose glucocorticoids (≤10 mg\u002Fday equivalent of prednisone) is permitted. The chronic use of topical, inhaled, and locally injected steroids is permitted\n15. Subjects who have received treatment with anthracyclines with a cumulative dose exceeding 360 mg\u002Fm2\n16. Subjects with known human immunodeficiency virus (HIV) infection (HIV antibody positive). Subjects are allowed to participate if all the following criteria are met:\n\n    1. Undetectable HIV RNA and CD4 count ≥ 350 cells\u002FμL at screening;\n    2. No AIDS-defining opportunistic infection within 12 months prior to screening;\n    3. On stable antiretroviral therapy (ART) for at least 4 weeks prior to enrollment with projected continuation of ART as clinically indicated while on the study.\n17. Subjects with known active hepatitis B virus (HBV) infection (positive HBsAg test). Subjects with a chronic inactive HBV infection are eligible if all the following criteria are met:\n\n    1. Have an HBV DNA viral load \\\u003C 500 IU\u002FmL;\n    2. Have normal AST and ALT, OR if liver metastasis is present, have AST and ALT \\\u003C3×ULN which are not attributed to HBV infection;\n    3. Are on antiviral treatment, as clinically indicated.\n18. Subjects with known active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA \\> the lower limit of detection). Subjects with a positive anti-HCV antibody are eligible only if quantitative polymerase chain reaction (PCR) is negative for HCV RNA\n19. Subjects with known active tuberculosis\n20. Subjects with active infections requiring IV antibiotic, antiviral, or antifungal treatment, such as severe pneumonia, bacteremia, sepsis, etc., within 1 week prior to first dose of study treatment. Subjects on stable oral antimicrobials with no clinical or laboratory evidence of active infection are eligible\n21. Subjects who are pregnant, breastfeeding, or planning to become pregnant during the study\n22. Other conditions that the investigator believes are not suitable for participating in this clinical trial.",{"count":52,"type":20},160,[23],"The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid Tumors.",[56,27,57,58,59],"Gastric Adenocarcinoma","Esophageal Adenocarcinoma","Biliary Tract Cancer","Other Solid Tumors",[61],"CLDN 18.2","RECRUITING","2026-04-29",{"date":65,"type":36},"2026-04-30",{"date":67,"type":36},"2025-07-30",{"date":69,"type":20},"2027-05-31",{"name":71,"class":72},"SystImmune Inc.","INDUSTRY",17,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":105},"100624351","nano-megestrol-acetate-for-cancer-cachexia-in-advanced-pancreatic-cancer-100624351","NCT07408505","Nano-Megestrol Acetate for Cancer Cachexia in Advanced Pancreatic Cancer","Efficacy and Safety of Nano-Megestrol Acetate in the Treatment of Anorexia-Cachexia Syndrome in Patients With Advanced Pancreatic Cancer: A Randomized, Controlled, Prospective Study","Inclusion Criteria:\n\n* Patients must meet all of the following criteria to be eligible for enrollment:\n\n  1\\. Pancreatic cancer-specific inclusion criteria:\n  1. Histologically or cytologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma according to the TNM staging system of the International Association of Pancreatology and the 8th edition of the American Joint Committee on Cancer (AJCC);\n  2. No prior systemic antitumor therapy for recurrent or metastatic disease;\n  3. Prior adjuvant or neoadjuvant chemotherapy, radiotherapy, chemoradiotherapy, or immunotherapy for non-metastatic disease is allowed, provided that at least 6 months have elapsed since completion of the last treatment without disease recurrence;\n  4. At least one measurable lesion according to RECIST version 1.1 (previously irradiated lesions may be considered measurable only if there is clear evidence of disease progression after radiotherapy).\n\n  2\\. Fulfillment of Fearon criteria for cachexia or pre-cachexia:\n\n  (1) Cachexia stage according to Fearon criteria: fulfillment of any of the following criteria in combination with decreased appetite (FAACT-A\u002FCS 12 score ≤ 37) or systemic inflammation (CRP \\> 5 mg\u002FL):\n\n  ① Unintentional weight loss \\> 5% within the past 6 months;\n  * Body weight loss \\> 2% in patients with a BMI \\\u003C 18.5 kg\u002Fm². (2) Pre-cachexia stage according to Fearon criteria: all of the following three conditions must be met:\n\n    ① Unintentional weight loss ≤ 5% within the past 6 months;\n  * Systemic inflammation (CRP \\> 5 mg\u002FL);\n\n    ③ Decreased appetite (FAACT-A\u002FCS 12 score ≤ 37). 3. General inclusion criteria:\n    1. Good compliance and provision of written informed consent;\n    2. Age 18-75 years, regardless of sex;\n    3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n    4. Expected survival greater than 4 months;\n    5. Adequate organ function, defined as follows:\n\n       • Hematologic function: absolute neutrophil count ≥ 1.5 × 10⁹\u002FL, hemoglobin ≥ 9 g\u002FdL, platelet count ≥ 100 × 10⁹\u002FL;\n\n       • Hepatic function: total bilirubin ≤ 1.5 × upper limit of normal (ULN) (patients with known Gilbert's syndrome may be enrolled if serum bilirubin ≤ 3 × ULN), AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN in the presence of liver metastases), and alkaline phosphatase ≤ 3 × ULN (≤ 5 × ULN in the presence of liver or bone metastases); serum albumin ≥ 3 g\u002FdL;\n\n       • Coagulation function: international normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN;\n\n       • Renal function: creatinine clearance ≥ 60 mL\u002Fmin as calculated by the Cockcroft-Gault formula;\n       * Urinary protein: urine protein ≤ 1+ on dipstick or 24-hour urine protein \\\u003C 1.0 g;\n       * Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%.\n    6. Women of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to first dosing (if a urine pregnancy test cannot be confirmed as negative, a serum pregnancy test is required and shall prevail). Women of childbearing potential who engage in sexual activity with non-sterilized male partners must use an acceptable method of contraception from screening and agree to continue contraception for 120 days after the last dose of study medication; decisions regarding discontinuation of contraception after this time point should be discussed with the investigator. Male patients who engage in sexual activity with women of childbearing potential must use effective contraception from screening until 120 days after the last dose of study medication; decisions regarding discontinuation of contraception after this time point should be discussed with the investigator.\n\n       Exclusion Criteria:\n* Patients meeting any of the following criteria will be excluded from this study:\n\n  1\\. Cancer-specific exclusion criteria:\n  1. Active or untreated CNS metastases (e.g., brain or leptomeningeal metastases) as determined by CT or magnetic resonance imaging (MRI) during screening or based on prior imaging assessments. Patients with previously treated brain or leptomeningeal metastases may be eligible if the disease has been stable for ≥ 2 months and systemic corticosteroid therapy (\\>10 mg\u002Fday prednisone or equivalent) has been discontinued for \\> 4 weeks prior to randomization.\n  2. Uncontrolled tumor-related pain;\n\n  (1) History of thromboembolic disease, ascites, or lower extremity edema within the past 6 months; (3) History of malignancy other than pancreatic cancer within 5 years prior to randomization, except for malignancies with negligible risk of metastasis or death (e.g., expected 5-year overall survival \\> 90%) and considered curable after appropriate treatment, such as adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer treated with curative surgery, and ductal carcinoma in situ treated with curative surgery; (4) Unresolved toxicity from prior anticancer therapy, defined as failure to recover to NCI CTCAE version 5.0 grade 0 or 1 (except alopecia) or failure to recover to levels specified in the inclusion\u002Fexclusion criteria; (5) Patients with peritoneal metastases will be excluded. 2. General medical exclusion criteria:\n  1. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;\n  2. Patients with hepatitis B or hepatitis C:\n\n     ① Patients with a history of hepatitis B virus (HBV) infection must undergo HBV deoxyribonucleic acid (DNA) testing; only patients with negative HBV DNA (HBV DNA \\\u003C 1000 copies\u002FmL or \\\u003C 200 IU\u002FmL or below the upper limit of normal) are eligible for participation in this study;\n\n     ② Among patients who are positive for hepatitis C virus (HCV) antibodies, only those with negative HCV ribonucleic acid (RNA) by polymerase chain reaction (PCR) testing are eligible to participate in this study;\n  3. Patients with a positive test result for human immunodeficiency virus (HIV);\n  4. Major surgery (excluding diagnostic procedures) within 28 days prior to randomization, or anticipated major surgery during the study period;\n  5. Significant cardiovascular disease, such as heart disease defined as New York Heart Association class II or higher, myocardial infarction within 3 months prior to randomization, unstable arrhythmia, unstable angina, cerebrovascular accident, or transient ischemic attack. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction \\\u003C 50% must be receiving optimal stable therapy as determined by the treating physician; consultation with a cardiologist may be obtained if necessary;\n  6. Severe infection occurring within 4 weeks prior to first dosing, including but not limited to infections with complications requiring hospitalization, sepsis, or severe pneumonia; or active infection requiring systemic anti-infective therapy within 2 weeks prior to first dosing (excluding antiviral therapy for hepatitis B or C).\n\n  3\\. Drug-related exclusion criteria:\n  1. Conditions affecting gastrointestinal absorption, including dysphagia, malabsorption, or uncontrolled vomiting; difficulty in food intake or requirement for tube feeding or parenteral nutrition; anorexia nervosa; anorexia caused by psychiatric disorders or pain-related inability to eat;\n  2. Current or planned use of other medications that increase appetite or body weight, such as corticosteroids (except short-term dexamethasone use during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants;\n  3. Cushing's syndrome, adrenal or pituitary insufficiency; poorly controlled diabetes mellitus; or current hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg despite treatment with oral antihypertensive agents;\n  4. History within 6 months prior to first dosing of esophageal or gastric varices, severe ulcer disease, gastrointestinal perforation and\u002For fistula, gastrointestinal obstruction (including incomplete obstruction requiring parenteral nutrition), intra-abdominal abscess, or acute gastrointestinal bleeding;\n  5. Known hypersensitivity to any component of the study drug;\n  6. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.","75 Years",{"count":83,"type":20},56,[85],"NA","Cancer anorexia-cachexia syndrome is a common and severe complication in patients with advanced cancer, with a particularly high prevalence in pancreatic cancer. It is associated with systemic inflammation, metabolic disturbances, and dysregulation of central appetite control, leading to reduced quality of life, poor tolerance to anticancer therapy, and shortened survival. Anticancer treatments, including chemotherapy and immunotherapy, may further exacerbate the development and progression of cachexia.\n\nMegestrol acetate is recommended as a first-line treatment for cancer-related anorexia-cachexia syndrome by multiple international and national guidelines, based on its proven effects on appetite stimulation, weight gain, and quality of life improvement. The nanocrystalline formulation of megestrol acetate significantly enhances bioavailability and achieves effective plasma concentrations even in the fasting state, making it particularly suitable for patients with cancer cachexia.\n\nThis randomized, controlled, prospective study aims to evaluate the efficacy and safety of nanocrystalline megestrol acetate in patients with advanced pancreatic cancer complicated by cancer anorexia-cachexia syndrome. The study will assess improvements in appetite, body weight, nutritional status, and quality of life, and explore the clinical value of early anti-cachexia intervention in the era of immuno-chemotherapy, providing evidence to optimize comprehensive treatment strategies for advanced pancreatic cancer.",[27,88],"Cancer Anorexia-Cachexia Syndrome",[90,91,92,93,94],"Pancreatic ductal adenocarcinoma","Cancer anorexia-cachexia syndrome","Nanocrystalline megestrol acetate","Body weight and body composition","Appetite improvement","2026-04-23",{"date":97,"type":36},"2026-04-27",{"date":99,"type":20},"2026-06-01",{"date":101,"type":20},"2028-02-20",{"name":103,"class":104},"Shandong Cancer Hospital and Institute","OTHER",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":105},"100619706","phase-1-atra-and-sdk002-in-combination-with-chemotherapy-and-anti-pd-1-inhibitor-in-patients-with-advanced-pancreatic-ductal-adenocarcinoma-100619706","NCT07348107","ATRA and SDK002 in Combination With Chemotherapy and Anti-PD-1 Inhibitor in Patients With Advanced Pancreatic Ductal Adenocarcinoma.","A Phase 1 Study of ATRA and SDK002 in Combination With Chemotherapy and Anti-PD-L1 Inhibitor in Patients With Advanced Pancreatic Ductal Adenocarcinoma.","ATARI-PDAC","Inclusion Criteria\n\n* Participants must have previously untreated unresectable\u002F metastatic PDAC, without plans for a curative surgery, previous neoadjuvant therapy with 5-FU based therapy is permitted but neoadjuvant gemcitabine-based therapy must have been completed at least 6-months prior to enrollment without documented progression while on gemcitabine. Unresectable PDAC is determined based surgical assessment deeming that curative resection is not foreseeable or appropriate.\n* Participants should have adequate archival tissue (from primary or metastatic tumour) available and must have provided informed consent for the release of this tissue. For potential participants who do not have adequate residual tissue or a biopsy which was only suspicious for adenocarcinoma approval from the sponsor prior to enrollment is required.\n* Participants must be ≥ 18 years of age.\n* Participants must have an ECOG performance status of 0 to 2.\n* Participants must have a life expectancy of 3 months or longer.\n* Laboratory requirements (must be done within 7 days prior to enrollment):\n* Absolute neutrophils: ≥ 1.5 × 109\u002FL (without granulocyte colony-stimulating factor support within 2 weeks prior to the first study treatment)\n* Hemoglobin: ≥ 90 × 109\u002FL\n* Platelets: ≥ 100 × 109\u002FL\n* Bilirubin: \\\u003C 1.5 × ULN (Note: Exceptions may be made if confirmed diagnosis of Gilberts (\\\u003C 3 × ULN); ≤ 5.0 × ULN if participant has liver metastases or partial biliary obstruction post stenting or drainage and felt to be stable\n* AST and ALT: \\\u003C 2.5 × ULN; ≤ 5.0 × ULN if participant has liver metastases or partial biliary obstruction post stenting or drainage and felt to be stable\n* ALP: \\\u003C 2.5 × ULN; ≤ 5.0 × ULN if participant has liver metastases or partial biliary obstruction post stenting or drainage and felt to be stable\n* Serum creatinine and creatinine clearance: ≥ 45 mL\u002Fmin; (Note: Creatinine clearance to be measured directly by 24-hour urine sampling or as calculated by Cockcroft and Gault equation below:\n\nFemales: GFR = 1.04 × \\[140-age\\] × weight in kg \u002F serum creatinine in μmol\u002FL\n\nMales: GFR = 1.23 × \\[140-age\\] × weight in kg \u002F serum creatinine in μmol\u002F)\n\n* Participants must be able to swallow oral medications and have no known gastrointestinal disorders that may interfere with absorption (such as malabsorption).\n* Patients must have received no prior systemic therapy in the first-line setting for unresectable\u002Fmetastatic disease.\n* Prior chemotherapy: prior chemotherapy in the adjuvant\u002Fneoadjuvant setting is allowed provided \\> 6 months from last chemotherapy at time of enrolment for gemcitabine-based therapies, no time restrictions for 5-FU based therapies; patients must have had recovered (to grade 1 or better) from all reversible toxicity related to prior chemotherapy or systemic therapy.\n* Radiation: Prior external beam radiation is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and date of enrollment. Exceptions include low-dose, non-myelosuppressive radiotherapy to sites outside of the primary disease such as palliative radiation to bone metastases. Concurrent radiotherapy is not permitted.\n* Surgery: Previous surgery is permitted provided that a minimum of 21 days (3 weeks) have elapsed between any major surgery and date of enrollment, and that wound healing has occurred. Stenting, percutaneous cholecystostomy, and endoscopies are permitted.\n* Interventional Radiology: Prior radioembolization is permitted up to 4 weeks prior to enrolment. Interventional pain control such as celiac axis block allowed prior to treatment.\n* Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to screening (if applicable)\u002Fenrollment in the trial to document their willingness to participate.\n* Participants must be accessible for treatment and follow up. Participants enrolled in this trial must be treated and followed at the participating center. Investigators must assure themselves the participants enrolled in this trial will be available for complete documentation of the treatment, AEs, and follow-up.\n* Participants of childbearing potential (WOCBP) must agree to use a highly effective contraceptive method. A woman is considered to be of \"childbearing potential\" if she has had menses at any time in the preceding 12 consecutive months.\n* WOCBP will have a pregnancy test to determine eligibility as part of the pre-study evaluation; this may include an ultrasound to rule-out pregnancy if a false-positive is suspected. For example, when beta-human chorionic gonadotropin (hCG) is elevated from a possible tumour source. Participants will be considered eligible if an ultrasound is negative for pregnancy.\n\nMale participants should also refrain from donating sperm during the study and for 6 months after the last dose of study treatment.\n\n-Women must refrain from breastfeeding while on treatment.\n\nExclusion Criteria\n\n* Participants with any medical condition that would impair the administration of oral agents including significant bowel resection, inflammatory bowel disease or uncontrolled vomiting.\n* Participants with a history of other malignancies, except adequately treated non-melanoma skin cancer and low-grade prostate cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for \\> 2 years.\n* Participants may not receive concurrent treatment with other anti-cancer therapy (other than bone-targeted therapy, GnRH agonist\u002Fantagonist, or adjuvant tamoxifen and aromatase inhibitors if already taking and stable) or investigational agents while on protocol therapy. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n* Participants with history of allogeneic organ transplantation.\n* Participants with active autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], systemic lupus erythematosus, Sarcoidosis syndrome, or granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]) that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* The following autoimmune are exceptions to this criterion: 1) participants with vitiligo or alopecia; 2) participants with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; 3) participants with any chronic skin condition that does not require systemic therapy; 4) participants with celiac disease controlled by diet alone; 5) participants without an active disease in the last 5 years may be included but only after consultation with the principal investigator.\n* Current or prior use of immunosuppressive medications within 14 days before first drug dose.\n* The following are exceptions to this criterion: 1) intranasal, inhaled, or topical steroids or local steroid injections (e.g., intra-articular injection); 2) systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent; 3) steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) or steroids a single oral dose are permitted\n* History of active primary immunodeficiency.\n* Participants who have received growth factors within 28 days prior to initiation of dosing of ATRA and SDK002.\n* Primary prophylaxis not allowed, but secondary prophylaxis is permitted.\n* Participant has known active, uncontrolled HIV, or hepatitis B or C infection.\n* Participants with undetectable viral load are eligible.\n* Participants with serious illnesses which would not permit the participant to be managed according to the protocol.\n* Uncontrolled intercurrent illness includes but is not limited to: clinically active diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease (ILD), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase the risk of incurring AEs, or compromise the ability of the participant to give written informed consent.\n* Participant deemed by the investigator to be at high cardiovascular risk, specifically including, but not limited to, recent coronary stenting or myocardial infarction in the 6 months before screening, or QTc ≥ 490 ms for males or ≥ 470 ms for females.\n* Participants with pre-existing sensory neuropathy \\> grade 1.\n* Participants with history of central nervous system metastases or spinal cord compression unless they have received treatment, are clinically stable and do not require corticosteroids.\n* Participants with symptomatic ascites or pleural effusion. Participants who are clinically stable following treatment for these conditions (including therapeutic thoracentesis or paracentesis) are eligible.\n* Participants are not eligible if they have a known hypersensitivity to the study drug(s) or their components.\n* Major surgical procedure within 28 days before the first dose of study treatment.\n* Participants who have received prior immune-mediated therapy, including, but not limited to, other anti-PD-1, anti PD-L1, or anti CTLA-4.\n* Participant is taking any additional cytotoxic anti-cancer medications, other prohibited concurrent medication, including vitamin A supplements, isotretinoin, and is unwilling to stop use prior to and during the trial.\n* Participant has received a live vaccine within 4 weeks before receiving their first dose of study treatment.\n* Participant is unwilling or unable to comply with study procedures, as assessed by the Principal Investigator.\n* Is pregnant, breastfeeding, or is of reproductive potential and unwilling to comply with contraceptive requirements as described in Appendix 5.",{"count":115,"type":20},10,[23],"This study is testing whether adding three drugs, All-Trans Retinoic Acid (ATRA), SDK002 (also called Arsenic Trioxide or ATO), and tislelizumab, to standard chemotherapy is safe for people with advanced pancreatic cancer. Advanced pancreatic cancer means the cancer has spread or cannot be removed with surgery. The study will also look at whether this treatment combination may help people live longer.\n\nParticipants will receive standard chemotherapy drugs, gemcitabine and nab-paclitaxel, together with ATRA, SDK002, and tislelizumab. ATRA is related to vitamin A and may affect how cancer cells grow. SDK002 is a drug used to treat sine cancers and may help other treatments work better. Tislelizumab is an immunotherapy drug, which helps the immune system recognize and attack cancer cells. This is a phase 1 study, which means the main goal is to test safety and side effects. All participants receive the same treatment, and both the study doctors and participants know which drugs are being given.",[27],[120,121,122,123,124,125,126,127,128,129,130,131,132,133,134],"Advanced pancreatic ductal adenocarcinoma","Metastatic","PDAC","ATRA (all-trans retinoic acid)","SDK002","Tislelizumab","Gemcitabine","Nab-paclitaxel","Immune checkpoint inhibitor","Phase 1","Combination therapy","Safety and tolerability","First-line treatment","Chemotherapy","Immunotherapy","2026-01-09",{"date":137,"type":36},"2026-01-16",{"date":139,"type":20},"2026-02-15",{"date":141,"type":20},"2027-03",{"name":143,"class":104},"Daniel Breadner",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":166},"100579534","phase-2-icaritin-in-combination-with-ag-in-patients-with-previously-untreated-advanced-pancreatic-ductal-adenocarcinoma-100579534","NCT06825546","Icaritin in Combination With AG in Patients With Previously Untreated Advanced Pancreatic Ductal Adenocarcinoma","A Multicenter Study Assessing the Efficacy and Safety of Icaritin in Combination With AG Chemotherapy Versus AG Chemotherapy Alone in Patients With Previously Untreated Advanced Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n1. 18-80 years old (including the cutoff value).\n2. patients with histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) disease from multiple centers including Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (group lead unit).\n3. locally advanced or metastatic PDAC according to the 2024 CSCO Guidelines for the Management of Pancreatic Cancer.\n4. no prior systemic therapy.\n5. presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\n6. Eastern Cooperative Oncology Group PS 0 or 1.\n7. have a life expectancy of at least 3 months.\n8. adequate organ function (absolute neutrophil count ≥1.5×109\u002FL; Platelet count ≥100×109\u002FL; Creatinine \\\u003C1.5×ULN (upper limit of normal) or creatinine clearance (CRCI) ≥60 ml\u002Fmin; Albumin ≥30g\u002FL; Total bilirubin \\\u003C5×ULN; Aspartate aminotransferase (AST) \\\u003C2.5×ULN; Alanine aminotransferase (ALT) \\\u003C2.5×ULN (≤5×ULN is acceptable if liver metastasis is present); INR or PT \\\u003C 1.5×ULN, APTT \\\u003C 1.5×ULN.\n9. in a fertile woman, a negative serum pregnancy test within 7 days before the first trial treatment;\n10. willingness to use a highly effective contraceptive method (failure rate \\\u003C 1.0% per year) from the first study treatment until 24 weeks after completion of the trial treatment, if the woman is fertile or the male participant's partner is fertile.\n11. no other serious underlying medical conditions.\n12. voluntarily participated in this study and signed informed consent. If the subjects were unable to read and sign the informed consent form due to incapacity or other reasons, their guardians were required to act for them during the informed consent process and sign the informed consent form. If the subjects were unable to read the informed consent form (e.g., illiterate subjects), witnesses were required to witness the informed consent process and sign the informed consent.\n\nExclusion Criteria:\n\n1. neuroendocrine (carcinoid, islet cell) or pancreatic acinar carcinoma.\n2. Patients had moderate to severe ascites (ascites was defined by B-ultrasound).\n3. untreated active central nervous system or meningeal metastases.\n4. Previous systemic therapies such as targeted therapy, immunotherapy, chemotherapy, and modern Chinese medicine with anti-tumor indications or other treatments such as surgery and particle implantation have been used to treat pancreatic cancer.\n5. surgery for any reason (other than diagnostic biopsy), within 4 weeks after the first trial treatment, and\u002For the subject did not fully recover from surgery within 4 weeks after the first trial treatment.\n6. history of RT within 3 months of the first dose of trial treatment. No more than 30% bone marrow irradiation or large field irradiation should be used in the 4 weeks before the first trial treatment.\n7. patients with a history of other cancers within the past 2 years.\n8. major cardiovascular impairment in the 12 months before the first dose of study drug: such as a history of congestive heart failure higher than NYHA class II, unstable angina, myocardial infarction, or stroke due to cerebrovascular accident, or arrhythmia associated with hemodynamic instability; The corrected QT (QTc) interval was prolonged \\>480ms.\n9. with bleeding or thrombotic diseases or receiving thrombolytic therapy, and coagulopathy; Patients who were deemed by the investigator to be ineligible for participation in the study.\n10. clinically significant hemoptysis or tumor bleeding of any cause within 2 weeks before the first dose of study intervention.\n11. patients with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric illness, or hypertension The investigator will determine whether clinical severity prevents informed consent from being signed or affects patient adherence to oral medication.\n12. had active autoimmune disease requiring systemic therapy within the previous 2 years.\n13. may have other comorbidities that are relatively contraindicated in this trial.\n14. had a severe allergic reaction to the active ingredient of the trial drug.\n15. were pregnant or lactating, or were unwilling to plan pregnancy during the trial.\n16. any other medical condition that the investigator considered to interfere with the requirements of the trial in terms of safety or efficacy assessment or adherence to treatment.\n17. vulnerable groups except the elderly\u002Filliterate, including people with mental illness, cognitive impairment, critically ill patients, pregnant women, etc.","80 Years",{"count":153,"type":20},70,[24],"Icaritin is a drug that has been approved by the National Medical Products Administration (NMPA) based on a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial - SNG1705 ICR-1. It is used for patients with unresectable hepatocellular carcinoma who are not suitable for or refuse standard treatment and have not previously received systemic therapy. According to numerous studies, in tumor cells, Icaritin can downregulate the expression of TNF-α, IL-6, PD-L1 and exert anti-tumor effects. At the same time, it regulates the tumor immune microenvironment by reducing the secretion of TNFa and IL-6 as well as inhibiting PD-L1 expression through decreasing MDSC cell proportion. Importantly, Icaritin has excellent safety profile and greatly ensure patients' quality of life clinically. Rare grade 3-4 TRAEs were observed in clinical trials which is uncommon among existing standard drugs. Good safety is a prerequisite for combination therapy; therefore, further exploration of optimal drug combinations is worth considering. Thus,we investigated the efficacy and safety of Icaritin administered in conjunction with AG in patients newly diagnosed with advanced pancreatic ductal adenocarcinoma, compare with AG only.",[27],"2025-06-25",{"date":159,"type":36},"2025-06-27",{"date":161,"type":36},"2025-04-01",{"date":163,"type":20},"2027-10-01",{"name":165,"class":104},"Sir Run Run Shaw Hospital",6]