Adamantinomatous Craniopharyngioma
Conditions
Interventions
Trial group:Sacituzumab tirumotecan (SKB264) monotherapy administered at 5.0 mg/kg via intravenous infusion every 2 weeks, with each two-week period constituting one treatment cycle, for a minimum of
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Eligible participants must meet all of the following criteria: 1. Age between 18 and 75 years, either gender; 2. Histologically confirmed diagnosis of adamantinomatous craniopharyngioma (ACP) following surgical resection; 3. Radiologically confirmed tumor recurrence after surgery or following radiotherapy/chemotherapy, with no standard therapeutic options available; 4. TROP2 immunohistochemistry expression score >=2+ (as determined by the central pathology laboratory); 5. ECOG performance status of 0–2; 6. Adequate organ function, meeting the following requirements: (1) Neutrophil count >=1.5×10^9/L, platelet count >=100×10^9/L; (2) ALT/AST =60 mL/min; (4) LVEF >=50%, with no significant arrhythmias; 7. Stable vital signs (blood pressure and heart rate within normal ranges); 8. Good compliance, capable of independently providing written informed consent and willing to complete all required treatments and follow-up assessments as per the study protocol.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria are excluded from this study: 1. Known hypersensitivity to skib264 (lucutuzumab vedotin) or any of its excipients; 2. Received systemic anti-tumor therapy (e.g., chemotherapy, targeted therapy, immunotherapy, or other ADC agents) within 28 days prior to screening; 3. Concurrent active malignancy, or a history of any malignancy (excluding basal cell carcinoma of the skin or cervical carcinoma in situ) within the past 3 years; 4. History of intracranial or subarachnoid hemorrhage (including rupture of arteriovenous malformation); 5. Severe cardiovascular disease (e.g., NYHA class III–IV heart failure, QTcF >=470 ms); 6. Severe hepatic or renal impairment (AST/ALT >=3×ULN or creatinine clearance <50 mL/min); 7. Active bacterial, viral, or fungal infection (e.g., HBV DNA positive, HCV RNA positive, or HIV positive); 8. Concurrent severe psychiatric disorders, autoimmune diseases, or other systemic illnesses; 9. Pregnancy, lactation, or plans for pregnancy in the near future; 10. Participation in another interventional clinical trial concurrently; 11. Any other condition deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Adverse Events;Dose-limiting toxicity;Life quality score;Abnormalities in laboratory tests (including: complete blood count, liver and kidney function, electrolytes, hormone levels, etc.);Physical examination and vital signs monitoring (including: body temperature, blood pressure, heart rate, weight, neurological signs); | — |
Countries
China
Contacts
Public ContactChen Ge
Xuanwu Hospital, Capital Medical University
Outcome results
None listed