NCT07702305Not yet recruitingPhase 1
Safety and Efficacy of Intrathecal Sacituzumab Tirumotecan for Leptomeningeal Metastasis in EGFR-TKI-Resistant Non-Small Cell Lung Cancer
Safety and Efficacy of Intrathecal Injection of Sacituzumab Tirumotecan (SKB264) in the Treatment of Leptomeningeal Metastasis From EGFR-TKI-Resistant Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
This study is a Phase I, single-arm, single-center, dose-escalation clinical trial designed to investigate the safety and efficacy of intrathecal injection of sacituzumab tirumotecan (sac-TMT) in patients with EGFR mutation-positive non-small cell lung cancer and leptomeningeal metastasis who have progressed after prior EGFR-TKI therapy, and to determine the optimal dose (RP2D). The study employs an "accelerated titration" combined with a "3+3" dose-escalation design, with a starting dose of 0.05 mg/kg, sequentially escalating to 0.5 mg/kg. The drug is administered via intrathecal injection through an Ommaya reservoir once every 14 days, along with concomitant intrathecal injection of dexamethasone 5 mg to prevent chemical meningitis. The primary endpoints are safety (incidence, severity, and grading of adverse events and serious adverse events) and the recommended dose (RP2D). Secondary endpoints include intracranial objective response rate, time to treatment failure, progression-free survival, and overall survival. The study plans to enroll 8-15 subjects. Efficacy assessment is based on evaluation of neurological symptoms, cerebrospinal fluid cytology, and neuroimaging changes. Special attention is given to adverse events of special interest, including neurotoxicity and bone marrow suppression. This study aims to provide a new treatment strategy for patients with leptomeningeal metastasis after EGFR-TKI resistance and to generate pioneering data for the intrathecal administration of ADC drugs.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 9 Jul 2026
- Start date
- 23 Jun 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Henan Cancer Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07702305
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 15
- From 23 Jun 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active infectious disease within 7 days before the start of study drug treatment;
- Previous or current severe immunodeficiency disease;
Other illness
- History of allergy to any component of the study drug;
- History of severe hypersensitivity reaction to any monoclonal antibody;
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.
Other
- ECOG performance status ≥ 4;
- Patients currently participating in other interventional studies;
Who the study is looking for
- Age ≥ 18 years;
- Pathologically diagnosed as EGFR mutation-positive non-small cell lung cancer;
- Leptomeningeal metastasis confirmed by detection of tumor cells in cerebrospinal fluid cytology;
- Previously received targeted therapy against EGFR mutation and progressed;
- ECOG performance status ≤ 3;
- Neurological symptoms stable for more than 7 days (defined as no new or worsening neurological symptoms and no more than a 1-point change in ECOG score);
- If radiotherapy (including whole-brain radiotherapy, stereotactic radiotherapy, etc.) has been received, at least 7 days after completion; if other intrathecal therapy has been received, a washout period of at least 7 days;
- Absolute neutrophil count ≥ 1.5 × 10⁹/L, hemoglobin ≥ 80 g/L, platelet count ≥ 75 × 10⁹/L;
- Prothrombin time/international normalized ratio and partial thromboplastin time ≤ 1.5 × upper limit of normal;
- Total bilirubin ≤ 1.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (elevations of total bilirubin and transaminases caused by tumor may be relaxed to 3× and 5×, respectively), creatinine ≤ 2 × upper limit of normal; calculated creatinine clearance ≥ 50 mL/min.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.