OncoMatch/Clinical Trials/NCT06248515
A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors
Is NCT06248515 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sacituzumab govitecan-hziy for thymoma.
Treatment: Sacituzumab govitecan-hziy — The goal of this clinical trial is to study the effect of sacituzumab govitecan-hziy in adult patients with advanced thymoma and thymic carcinoma after progressing on at least one prior line of therapy. The main question it aims to answer is: • What is the overall response rate (ORR) in patients with advanced thymoma and thymic carcinoma? Participants will: * receive a fixed dose of 10 mg/kg given intravenously, once weekly on Days 1 and 8 of continuous 21-day treatment cycles until disease progression or unacceptable toxicity * have regular blood tests, scans, and examinations to monitor their health. * have blood and a biopsy of their tumor for research purposes.
Check if I qualifyExtracted eligibility criteria
Disease stage
Metastatic disease required
Patients with histologically confirmed advanced thymoma or thymic carcinoma; Measurable disease per RECIST v1.1
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy
Lab requirements
Blood counts
ANC 3E/= 1.5 x 10^9/L (1500/uL) without filgrastim support; Platelet count 3E/= 100 x 10^9/L (100,000/uL) without transfusion; Hemoglobin 3E/= 80 g/L (8 g/dL), may be transfused to meet criterion
Kidney function
Creatinine clearance 3E/= 30 mL/min (Cockcroft-Gault)
Liver function
AST, ALT, ALP 3C=/= 2.5 x ULN (exceptions: AST/ALT 3C=/= 5 x ULN with liver metastases; ALP 3C=/= 5 x ULN with liver or bone metastases); serum bilirubin 3C=/= 1.5 x ULN (or 3C=/= 3 x ULN with Gilbert disease)
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment: * Absolute neutrophil count (ANC) 3E/= 1.5 x 10^9/L (1500/uL) without filgrastim support * Platelet count 3E/= 100 x 10^9/L (100,000/uL) without transfusion * Hemoglobin (Hgb) 3E/= 80 g/L (8 g/dL). Patients may be transfused to meet this criterion. * Aspartate aminotransferase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) 3C=/= 2.5 x upper limit of normal (ULN), with the following exceptions: * Patients with documented liver metastases: AST and ALT 3C=/= 5 x ULN * Patients with documented liver or bone metastases: ALP 3C=/= 5 x ULN Serum bilirubin 3C=/= 1.5 x ULN with the following exception: patients with known Gilbert disease: serum bilirubin 3C=/= 3 x ULN * Creatinine clearance 3E/= 30 mL/min (calculated using the Cockcroft-Gault formula, see Appendix 2) * For patients not receiving therapeutic anticoagulation: INR and aPTT 3C=/= 1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stanford Cancer Institute · Palo Alto, California
- Lombardi Comprehensive Cancer Center, Georgetown University · Washington D.C., District of Columbia
- University of Chicago Medical Center · Chicago, Illinois
- John Theurer Cancer Center at Hackensack University Medical Center · Hackensack, New Jersey
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