A Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan in Se… (NCT07343453) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan in Second-Line and Subsequent Treatments for Advanced Thymic Epithelial Tumors
38 participantsStarted 2025-12-22
Plain-language summary
This is a single-arm, phase II study to evaluate the efficacy and safety of Sacituzumab Tirumotecan, a TROP2-directed antibody-drug conjugate, in patients with advanced thymic epithelial tumors who have received second-line or later therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Advanced (unresectable or metastatic) thymic epithelial tumor confirmed by histology or cytology.
✓. Progress after receiving at least first-line systemic therapy (chemotherapy or immune checkpoint inhibitor).
✓. According to RECISTv1.1 standard, there is at least one measurable lesion.
✓. No central nervous system metastasis or stable brain metastasis after treatment (asymptomatic and hormone withdrawal for ≥4 weeks).
✓. Age \> 18 years old, male or female.
✓. ECOG (Performance status, PS) score 0-1.
✓. Expected survival time ≥12 weeks.
✓. Organ function compliance (confirmed by laboratory examination within 14 days before treatment): Bone marrow function: I. Neutrophils ≥ 1500× 109/L; Ii. Platelets ≥ 100× 109/L; Iii. hemoglobin \> 90g/l; Renal function: I. Serum creatinine ≤1.5×ULN or creatinine clearance rate (CrCl). ≥50mL/min； Ii. Urine protein \< 2+or 24H urine protein quantitative \< \<1.0g；; Liver function: I, AST or ALT ≤ 3× ULN; For patients with liver metastasis, it can ≤5\*ULN； Ii. Total bilirubin ≤1.5×ULN, and liver metastasis patients ≤ 3× ULN; Iii: serum albumin (ALB) ≥ 28g/l; Coagulation function: NR or APTT≤1.5×ULN；; Cardiac function: Left ejection fraction (LEFF) ≥ 50%.
Exclusion criteria
✕. Previously received targeted drug therapy with Lucasatuzumab.
✕. Have received any drug therapy targeting topoisomerase I in the past, including antibody-coupled drug (ADC) therapy.
What they're measuring
1
Objective response rate（ORR）
Timeframe: Within one year after starting treatment.
✕. Patients with grade 3-4 interstitial lung disease.
✕. Subjects known to have meningeal metastasis, brain stem metastasis, spinal cord metastasis and/or compression, active or brain metastasis without local treatment. 5.Subjects with brain metastases who have previously received local treatment can participate in the study if they are clinically stable for at least 4 weeks before the first administration of the study treatment and do not need to use corticosteroids or anticonvulsants for at least 14 days before the first administration; For the subjects with brain metastases first discovered during screening, if they receive local treatment (such as radiotherapy), they must have imaging evidence to show that the brain metastases have not progressed for at least 4 weeks from the first imaging diagnosis of brain metastases, and they can only enter the group after confirming that the brain metastases are stable.
✕. Patients with previous malignant tumors (except skin malignant tumors other than melanoma, and carcinoma in situ in the following parts \[bladder, stomach, colorectal cancer, endometrium, cervix, melanoma or breast\]) cannot be included in this study. However, if the malignant tumor has achieved complete remission for five years or more, and no additional anti-tumor treatment is needed during this study, it can be included in the study.
✕. Myocardial infarction and uncontrolled arrhythmia occurred within 6 months before the first administration (including QTc interval ≥450ms for men and ≥ 470 ms for women) (QTc interval is calculated by Fridericia formula); Or grade III-IV cardiac insufficiency according to NYHA standard or left ventricular ejection fraction \< 50% by color Doppler echocardiography.
✕. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage. Only a small amount of pleural effusion, a small amount of ascites and a small amount of pericardial effusion without clinical symptoms shown by imaging can be included in the group.
✕. Subjects with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, abdominal abscess or acute gastrointestinal bleeding.