CMTS1215 injections for advanced, treatment-refractory solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, single-arm Phase 1/2 study enrolling at least eight adults with histologically confirmed, measurable solid tumors that are refractory to standard treatments. Participants will receive intratumoral injections of CMTS1215 under direct visualization or endoscopic guidance for up to 6–8 treatment cycles. Tumor response will be measured at 1 week and 4 weeks after treatment using RECIST 1.1 criteria, and safety will be monitored using standard adverse event grading. The trial builds on preclinical safety and efficacy data in mouse and canine models showing tumor tropism and oncolytic activity of the CMTS1215 Proteus mirabilis strain.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Faming Zhang, MD, PhD
• Email: fzhang@njmu.edu.cn
• Phone: 086-25-58509883

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.