[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-solid-tumors-with-mtap-deletion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-solid-tumors-with-mtap-deletion":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100577315","phase-1-a-phase-iaib-clinical-study-of-gh56-capsules-in-subjects-with-mtap-deleted-advanced-solid-tumors-100577315",false,"NCT06796699","A Phase Ia\u002FIb Clinical Study of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors（G-MAP 101）","A Multi-center, Single-Arm, Open-Label Phase Ia\u002FIb Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors","Inclusion Criteria:\n\n1. Willing to participate in the clinical trial, understand and sign the informed consent, and comply with the study visits and procedures.\n2. Male and female patients who are ≥12 years of age at consent .\n3. Histologically or cytologically confirmed advanced and\u002For metastatic malignancies with progression on \u002F intolerance to standard treatment or lack of effective standard treatment.\n4. Evidence of MTAP loss or homozygous MTAP\u002FCDKN2A deletion in tumor tissue.\n5. At least one measurable lesion as per RECIST v1.1 criteria.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.\n7. Survival expectations ≥ 12 weeks.\n8. Adequate organ function\n9. Has a negative serum pregnancy test result at screening and is able to comply with contraceptive-barrier requirements.\n\nExclusion Criteria:\n\n1. Subject has not recovered from a prior surgical procedure or has undergone any major surgery within 4 weeks prior to the first dose.\n2. Has received any anti-tumor agents within 28 days without delayed toxicity for the treatment of advanced tumors prior to the first administration of GH56 Capsule\n3. Has symptomatic or active progressive central nervous system (CNS) metastases such as molluscum contagiosum metastases.\n4. Subjects who have difficulty in swallowing and have a history of gastrointestinal surgery or other relevant medical disorders that may interfere with the absorption of GH56.\n5. Subjects had a malignant tumor other than the current tumor within 5 years prior to the first administration of GH56 Capsule, except for localized cancers that have been apparently cured or without disease progression or recurrence for at least 5 consecutive years.\n6. Uncontrolled or significant cardiovascular disease\n7. Subjects with documented positive virology status of hepatitis, as confirmed by Screening hepatitis B virus (HBV) and hepatitis C virus (HCV) tests, Human Immunodeficiency Virus (HIV).\n8. Conditions that the investigator considers inappropriate for participation in this clinical trial.","ALL","12 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a multicenter, single-arm, open-label, dose-escalation, dose-expansion study to evaluate the safety, tolerability, PK\u002FPD, and preliminary anti-tumor activity of GH56 Capsule in subjects with advanced solid tumors who have failed or are intolerant to standard treatment, or have no standard therapy. The clinical trial will be carried out in two parts: phase Ia study (dose escalation study) and phase Ib (dose expansion study).The Part Ib dose expansion study includes adult cohort and adolescent cohort (12-17 years of age).",[26],"Advanced Solid Tumors With MTAP Deletion","RECRUITING","2026-09-29",{"date":30,"type":31},"2026-10-02","ACTUAL",{"date":33,"type":31},"2025-03-07",{"date":35,"type":20},"2028-02-29",{"name":37,"class":38},"Suzhou Genhouse Bio Co., Ltd.","OTHER",25]