[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Taiho Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100414948","phase-1-study-of-ret-inhibitor-tas0953hm06-in-patients-with-advanced-solid-tumors-with-ret-gene-abnormalities-100414948",false,"NCT04683250","Study of RET Inhibitor TAS0953\u002FHM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities","Phase I\u002FII Study of the Selective RET Inhibitor TAS0953\u002FHM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities","MARGARET","Ages Eligible for Study:\n\n\\- Adult patient (The definition of adulthood shall comply with the regulatory requirements of each region)\n\nInclusion Criteria:\n\nPhase I - Common inclusion criteria for Dose-Escalation \u002F Dose-Expansion:\n\n* Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1\n* Available RET-gene abnormalities determined on tissue biopsy or liquid biopsy. If deemed appropriate by the investigator, determination on a pleural cell block or cell pellet is also acceptable.\n* Adequate hematopoietic, hepatic and renal function\n\nPhase I Dose-Escalation - Specific inclusion criteria:\n\n* Advanced solid tumors\n* Measurable and\u002For non-measurable disease as determined by RECIST 1.1\n* If patient has brain and\u002For leptomeningeal metastases, (s)he should be asymptomatic.\n\nPhase I Dose-Expansion - Specific inclusion criteria:\n\n* Patient with RET gene fusion :\n\n  * Cohort 1, 3: locally advanced or metastatic NSCLC patients naïve to RET selective inhibitors and no prior systemic anti-cancer treatment. Patients who have been treated with neo-adjuvant or adjuvant chemotherapy may be included if it has been completed at least 6 months prior to the first dose of the study.\n  * Cohort 2, 4: locally advanced or metastatic NSCLC patients with RET gene fusion and prior exposure to RET selective inhibitors.\n* Measurable disease as determined by RECIST 1.1\n* If patient has brain and\u002For leptomeningeal metastases,(s)he should have:\n\n  * asymptomatic untreated brain\u002Fleptomeningeal metastases off steroids and anticonvulsant for at least 7 days or\n  * asymptomatic brain metastases already treated with local therapy and be clinically stable on steroids and anticonvulsant for at least 7 days before study drug administration.\n\nPhase II :\n\n* Available RET-gene abnormalities determined on tissue or liquid biopsy\n* Locally advanced or metastatic:\n\n  * NSCLC patients with primary RET gene fusion and prior exposure to RET selective inhibitors;\n  * NSCLC patients with RET gene fusion and without prior exposure to RET selective inhibitors\n  * patients with advanced solid tumors that harbour RET gene abnormalities (other than NSCLC patients with primary RET gene fusions) and has failed all the available therapeutic options\n* Eastern Cooperative Oncology Group (ECOG) performance score of 0-2\n* Measurable disease as determined by RECIST 1.1\n* If patient has brain and\u002For leptomeningeal metastases,(s)he should have:\n\n  * asymptomatic untreated brain\u002Fleptomeningeal metastases off steroids and anticonvulsant for at least 7 days or\n  * asymptomatic brain metastases already treated with local therapy and be clinically stable on steroids and anticonvulsant for at least 7 days before study drug administration.\n* Adequate hematopoietic, hepatic and renal function\n\nExclusion Criteria:\n\nCommon exclusion criteria for Phase 1 and Phase 2\n\n* Investigational agents or anticancer therapy within 5 half-lives prior to the first dose of study drug\n* Major surgery (excluding placement of vascular access) within 4 weeks prior to the first dose of study drug or planned major surgery during the course of study treatment.\n* Whole Brain Radiotherapy within 14 days or other palliative radiotherapy within 7 days prior to the first dose of study drug, or persisting side effects of such therapy, in the opinion of the Investigator.\n* Clinically significant, uncontrolled, cardiovascular disease including myocardial infarction within 3 months prior to Day 1 of Cycle 1, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic Congestive Heart Failure (CHF) New York Heart Association (NYHA) class III-IV, and severe uncontrolled arterial hypertension, according to the Investigator's opinion.\n* QT interval corrected using Fridericia's formula (QTcF) \\>470 msec; personal or family history of prolonged QT syndrome or history of Torsades de pointes (TdP). History of risk factors for TdP\n* Treatment with strong CYP3A4 inhibitors within 1 week prior to the first dose of study drug or strong CYP3A4 inducers within 3 weeks prior to the first dose of study drug.\n\nPhase I Dose-Expansion - and Phase II specific exclusion criteria:\n\n* Presence of known EGFR, KRAS, ALK, HER2, ROS1, BRAF and METex14 activating mutations.","ALL","18 Years",{"count":20,"type":21},244,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Phase 1 and 2 trial to study the safety, pharmacokinetics, and efficacy of TAS0953\u002FHM06 in patients with advanced solid tumors with RET gene abnormalities. Phase 1 aims to determine the Maximum Tolerated Dose (MTD) and identify the Recommended Phase 2 Dose (RP2D) to be used in phase 2.",[28,29],"RET-altered Non Small Cell Lung Cancer","RET-altered Solid Tumors","RECRUITING","2026-02-28",{"date":33,"type":34},"2026-03-03","ACTUAL",{"date":36,"type":34},"2020-12-16",{"date":38,"type":21},"2031-03",{"name":40,"class":41},"Taiho Pharmaceutical Co., Ltd.","INDUSTRY",21,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100409178","phase-1-a-phase-1-trial-of-astx030-in-patients-with-myelodysplastic-syndrome-100409178","NCT04608110","A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic Syndrome","A Phase 1, Multi-center, Open-label, Uncontrolled, Dose-escalation Study to Evaluate the Pharmacokinetics of ASTX030 in Patients With Myelodysplastic Syndrome (MDS)","Inclusion Criteria:\n\n* Patients aged 20 years or older\n* Patients with a diagnosis of MDS (refractory anemia \\[RA\\], refractory anemia with ringed sideroblasts \\[RARS\\], refractory anemia with excess blasts \\[RAEB\\], refractory anemia with excess blasts in transformation \\[RAEB-T\\], or chronic myelomonocytic leukemia \\[CMML\\]) according to the French-American-British (FAB) classification Low-risk patients who fall under the risk category of low or intermediate-1 (Int-1) based on the International Prognostic Scoring System (IPSS) can be enrolled only if they are unlikely to respond to any other treatment or if they are currently being treated with azacytidine (AZA) injection\n* Patients with an ECOG PS score of 0 or 1 or with an ECOG PS score of 2 due to primary disease-associated conditions\n* Patients with adequate organ function as indicated below\n\n  1. Hepatic function: All of the following criteria must be satisfied.\n\n     * Total bilirubin ≤ 2.0 × upper limit of normal (ULN)\n     * Aspartate aminotransferase (AST) ≤ 2.5 × ULN\n     * Alanine aminotransferase (ALT) ≤ 2.5 × ULN\n  2. Renal function: Either of the following criteria must be satisfied.\n\n     * Serum creatinine ≤ 1.5 × ULN\n     * Creatinine clearance or glomerular filtration rate ≥ 50 mL\u002Fmin\n  3. Respiratory function: percutaneous arterial oxygen saturation (SpO2) ≥ 90%\n* Patients who are expected to survive for at least 3 months\n* Patients who give written consent to participate in the trial using the informed consent form approved by the institutional review board\n\nExclusion Criteria:\n\n* Patients who are unlikely to respond to AZA\n* Patients who have received chemotherapy, hormone therapy, antibody therapy, radiotherapy, or other exploratory anti-cancer treatments for the primary disease within 3 weeks prior to the first administration of the investigational medicinal product (IMP)\n* Patients who have used any other IMP or any privately imported medicine within 4 weeks prior to the first administration of IMP\n* Patients with heart disease of Class 3 or 4 according to the New York Heart Association classification\n* Patients with uncontrolled systemic disease or active infection\n* Patients with uncontrolled gastric or duodenal ulcer\n* Patients with prior or current interstitial lung disease\n* Patients with a history of surgical gastrectomy\n* Patients with life-threatening conditions\u002Fsymptoms, multiple organ failure, or other factors (including laboratory abnormalities) that, in the opinion of the investigator, are likely to affect their safety or the absorption and metabolism of AZA and cedazuridine (CED), or influence the trial evaluation\n* Patients with other malignancies (except appropriately treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ; prostate or breast cancer stabilized by endocrine therapies; and malignancies that have not relapsed for at least 1 year since the last successful treatment)\n* Patients who are positive for HIV antibody, HBV-DNA, or HCV antibody\n* Patients with any ≥ Grade 2 AE (except alopecia) associated with prior treatment of the primary disease. However, the parameters defined in inclusion criterion above are excluded.\n* Patients who have undergone a highly invasive and extensive surgical procedure within 4 weeks prior to the first administration of IMP\n* Patients who previously underwent or plan on undergoing hematopoietic stem cell transplantation\n* Patients with a history of hypersensitivity to the active ingredient or any excipient of IMP\n* Patients who are, in the opinion of the investigator, at high risk for being unable to comply with the trial protocol because of mental disorders or other medical conditions (alcohol\u002Fsubstance abuse or addiction)\n* Pregnant or nursing female patients, or female patients with a positive pregnancy test at screening. Nursing patients cannot participate in the trial even if they discontinue breastfeeding. Female patients must undergo a pregnancy test to confirm that they are not pregnant at screening. However, a pregnancy test is not necessary for female patients without childbearing potential (ie, patients with a history of bilateral oophorectomy or hysterectomy or who have been postmenopausal for at least 12 months except for cases where menopause could be due to the effect of antineoplastic treatment).\n* Sexually active males (except those with a history of bilateral orchiectomy) or females of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 3 months (males) and 6 months (females) after the last dose of IMP. If birth control is employed, 2 of the following precautions must be used: vasectomy, tubal ligation, intrauterine device, oral contraceptive, and condom (all methods approved or certified in Japan)\n* Patients who, in the opinion of the investigator, are otherwise ineligible to participate in the trial","20 Years",{"count":52,"type":21},40,[24],"The purpose of this study is to identify the doses of the oral azacitidine formulations and cedazuridine (CED) tablets which achieve a total AUC for AZA comparable to that for AZA injection at 75 mg\u002Fm2",[56],"Myelodysplastic Syndrome (MDS)","2025-11-25",{"date":59,"type":34},"2025-12-03",{"date":61,"type":34},"2020-10-30",{"date":63,"type":21},"2026-01",{"name":40,"class":41},10,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100439243","phase-1-ab122-platform-study-100439243","NCT04999761","AB122 Platform Study","Platform Study of AB122 Based Treatments in Patients with Advanced Solid Tumors","Inclusion Criteria:\n\n* Is male or female aged ≥ 18 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedures (except for Cohort E-2);\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 before administration of study treatment;\n* Has adequate organ function as defined by the following criteria:\n\n  * AST and ALT ≤ 3 × ULN; or if a patient with documented liver metastases, AST and ALT ≤ 5 × ULN\n  * T-Bil of ≤ 1.5 × ULN\n  * ANC ≥ 1500 \u002Fmm3 (ie, ≥ 1.5 × 109 \u002FL by International System of Units \\[SI\\]) (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor \\[G-CSF\\])\n  * Platelet count ≥ 100000 \u002Fmm3 (SI: ≥ 100 × 109 \u002FL) (excluding measurements obtained within 7 days after a transfusion of platelets)\n  * Hemoglobin value of ≥ 9.0 g\u002FdL excluding measurements within 4 weeks after a transfusion of packed red blood cells (RBCs) or whole blood\n* Has a life expectancy of at least 90 days;\n\nCohort A-1 and A-2\n\n* Japanese male and female;\n* Has a histologically or cytologically confirmed diagnosis of solid tumor;\n* Has disease progression after standard treatment for advanced or metastatic disease, are intolerant to the standard treatment;\n\nCohort B-1\n\n* Has a histologically or cytologically confirmed diagnosis of PDAC;\n* Has disease progression after or intolerant to one prior systemic chemotherapy for advanced or metastatic disease\n\nCohort B-2\n\n* Has a histologically or cytologically confirmed diagnosis of CRC.\n* Has been received one regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the chemotherapy\n\nCohort B-3 - Has a histologically or cytologically confirmed non-squamous NSCLC;\n\n* Has been received one or two regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the standard treatment\n* Has been most recently received regimen including an ICI (anti PD-1 antibodies, anti PD-L1 antibodies or anti CTLA-4 antibodies) and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotherapy followed by checkpoint inhibitor therapy), and all of the following criteria must be met:\n\n  * Received at least 2 doses at the most recent ICI therapy\n  * Radiographic complete response or partial response based on investigator assessment with ICI therapy\n  * Documented radiographic disease progression with above most recently received regimen\n\nCohort C-1\n\n* Has unresectable advanced or recurrent gastric cancer or gastroesophageal junction cancer as pathologically confirmed adenocarcinoma\n* Gastroesophageal junction cancer is defined as a tumor with an epicenter that is located within 2 cm proximal to and distal from the esophagogastric junction (the boundary of esophageal and gastric muscularis).\n* Has received 2-4 standard regimens listed below and has demonstrated disease progression according to imaging test during the most recent treatment or within 12 weeks after the final dose (The patient is eligible if the treatment is discontinued owing to SAEs, allergic reactions, or neurotoxicities.):\n\n  * fluoropyrimidines and platinum\n  * taxane or irinotecan\n  * ramucirumab\n\nCohort C-2\n\n* Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded)\n* RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy; Wild type is defined as v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) (exon 2, 3 and 4) and neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS) (exon 2, 3 and 4) wild type. \\[Mutant is defined as at least KRAS or NRAS mutant (any exon, any mutation)\\].\n* Has received at least 2 prior chemotherapy regimens for the treatment of advanced CRC and had demonstrated disease progression according to imaging test during the most recent treatment or within 12 weeks after the final dose , or intolerance to their last regimen, and all of the following criteria must be met:\n\n  * Prior treatment regimens must have included a fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody\n  * For RAS wild-type patients, an anti-EGFR monoclonal antibody must have included in addition to above\n\nCohort D-1\n\n* Has histologically confirmed advanced or metastatic NSCLC regardless of histologic type.\n* Has PD-L1 (≥ 50% tumor proportion score) in tumor tissue sample as determined at a local laboratory.\n\nCohort D-2\n\n* Has histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-3\n\n* Has histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus.\n* No prior therapy for advanced or metastatic disease, or refractory or intolerant to at least 1 cycle of standard first-line therapy.\n\n  * Treatment discontinued due to intolerable toxicity or because the same drug cannot be re-treated before the disease progresses is considered as intolerable to the previous treatment.\n  * Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-4\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).\n\n  * The confirmed status of the human papillomavirus (HPV) in cancers of the mid-pharynx.\n  * Patient background such as combined positive score (CPS) and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy. • Treatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.\n\nCohort D-5\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).\n\n  * The confirmed status of the HPV in cancers of the mid-pharynx.\n  * Patient background such as CPS and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy. • Treatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.\n\nCohort D-6\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous NSCLC.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-7\n\n* Has histologically confirmed unresectable or advanced biliary tract cancer (intrahepatic bile duct, extrahepatic bile duct, gallbladder, or duodenal papillary region) with a diagnosis of adenocarcinoma or adenosquamous carcinoma.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-8\n\n* Has histologically confirmed unresectable or advanced pancreatic ductal adenocarcinoma (highly differentiated, moderately differentiated, or poorly differentiated).\n* No prior therapy for advanced or metastatic disease. Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort E-1\n\n* Has a histologically or cytologically confirmed advanced or metastatic NSCLC regardless of histologic type.\n* Has PD-L1 (≥ 50% tumor proportion score) in tumor tissue sample as determined at a local laboratory (except for tolerability part).\n* Has been received 1-4 regimen for advanced or metastatic disease\n* Has been received one regimen of ICI monotherapy or combination therapy (anti PD-1 antibodies, anti PD-L1 antibodies or anti CTLA-4 antibodies), and all of the following criteria must be met:\n\n  * Received at least 2 doses of the ICI therapy\n  * Documented radiographic disease progression with or after ICI therapy\n\nCohort E-2\n\n* Has a histologically or cytologically confirmed advanced or metastatic ASPS\n* Is male or female aged ≥ 16 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedure\n\nExclusion Criteria:\n\n* History or current evidence of cardiac arrhythmia and\u002For conduction abnormality: Any factor that can increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, etc.;\n* Treatment with any of the following within the specified time frame prior to the day on which study treatment is scheduled to be started:\n\n  * Major surgery within 4 weeks (the surgical incision should be fully healed prior to the day on which study treatment is scheduled to be started);\n  * Extended-field radiotherapy within 4 weeks or limited-field radiotherapy within 2 weeks;\n  * Any anticancer therapy within 2 weeks;\n  * Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever shorter;\n* Unresolved toxicity of ≥ Grade 2 attributed to any prior therapies (excluding anemia, peripheral sensory neuropathy, alopecia and skin pigmentation);\n* A serious illness or medical condition(s) including, but not limited to, the following specific medical conditions:\n\n  * Known acute systemic infection;\n  * Known medical history of interstitial lung disease\u002F drug-induced interstitial lung disease\u002F radiation pneumonitis which required steroid treatment\u002F any evidence of clinically active interstitial lung disease;\n  * Myocardial infarction, severe\u002Funstable angina, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class III or IV, Appendix A) within the previous 6 months; if \\> 6 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms;\n  * Known severe chronic kidney disease;\n  * Known positivity of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody in baseline virus test. In addition, the patient who is known negative in HCV ribonucleic acid (RNA) is eligible, even if positive for HCV antibody;\n  * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment, or may interfere with the interpretation of study results, and in the judgment of the investigator or sub-investigator would make the patient inappropriate for entry into this study;\n* Previous or concurrent cancer that is distinct in primary disease or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (stage Ta, Tis and T1), cancers corresponding to intraepithelial or intramucosal neoplasia, or any cancer curatively treated \\> 5 years prior to the day on which study treatment is scheduled to be started;\n* WOCBP or male patients who do not agree to effective birth control during the following period\n\n  1. WOCBP patients: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, TAS-102, TAS-120 or TAS-115, whichever is later;\n  2. Male patients with WOCBP partners: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, TAS-102, TAS-120 or TAS-115, whichever is later;\n* Prior treatment with an anti-PD-L1 anti-PD-1, anti-CTLA-4, or other ICI or agonist as monotherapy or in combination (except for cohort B-3, C-1, D-1 tolerability part and E-1).\n* Has received a live vaccine within 30 days prior to study treatment including, but not limited to the following examples: measles, mumps, rubella, varicella-zoster, yellow fever, and BCG. The inoculation with inactivated vaccines for seasonal influenza is allowed.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to enrollment.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 28 days by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to enrollment.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient\\'s participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. (eg, paresis of intestine, intestinal obstruction, unable to receive 5% dextrose in water \\[DW\\] in patients with diabetes mellitus, respiratory failure, renal failure, hepatic failure, cerebrovascular disorder, gastrointestinal ulcers that require transfusion or are hemorrhagic, and wounds\u002Fbone fractures associated with neovascularization during the healing process, accumulation of pleural within 2 weeks prior to enrollment, ascitic, or pericardial fluid requiring drainage)",{"count":74,"type":21},917,[24],"This is a phase 1, non-randomized open-label, multicenter platform study designed to evaluate the tolerability and safety of AB122 in patients with malignancies specified in each cohort.",[78,79,80,81,82,83,84,85,86],"Advanced or Metastatic Solid Tumor","Pancreatic Ductal Adenocarcinoma","Colorectal Cancer","Non-small Cell Lung Cancer","Gastric Cancer","Alveolar Soft Part Sarcoma","Esophageal Cancer","Head and Neck Cancer","Biliary Tract Cancer","2024-09-23",{"date":89,"type":34},"2024-09-25",{"date":91,"type":34},"2021-06-01",{"date":93,"type":21},"2026-05",{"name":40,"class":41},9,""]