Study of CMTS1215 Injection in Patients With Solid Tumors

Summary

This is a prospective, open-label, single-arm exploratory clinical trial to evaluate the safety and efficacy of CMTS1215 (Proteus mirabilis) oncolytic bacteria injection for the treatment of solid tumors. The study aims to enroll at least 8 patients with histologically confirmed solid tumors who have failed or are unable to complete conventional first-line, second-line, or third-line anti-tumor therapies.

Eligibility

Inclusion Criteria:

1. Adults aged 18 years or older, any gender
2. Histologically confirmed solid tumor with measurable lesions according to RECIST 1.1
3. Failed or unable to complete conventional first-line, second-line, or third-line anti-tumor therapies, with multidisciplinary team consensus that no other suitable treatment options are available
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
5. Expected survival time \> 3 months 6 Voluntary participation with signed informed consent

Exclusion Criteria:

1. Uncontrolled cardiovascular disease (e.g., heart failure NYHA III-IV, coronary artery disease, cardiomyopathy, arrhythmia)
2. Active severe clinical infection (\> Grade 2 NCI-CTCAE v5.0), including fungal, viral, or tuberculosis infection
3. Coagulation abnormalities with bleeding tendency (INR outside normal range without anticoagulants within 14 days prior to enrollment); patients on anticoagulants or vitamin K antagonists (warfarin, heparin, or similar)
4. History of immunodeficiency, acquired or congenital immunodeficiency diseases, or organ transplantation
5. Lactating female patients
6. Currently participating in other clinical studies
7. Women of childbearing potential planning pregnancy during the study period
8. Patients with allergies to common antibiotics
9. Patients lacking or with restricted legal capacity
10. Other patients deemed unsuitable for enrollment by the investigator

Conditions2

Interventions1

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