CMTS1215 injections for advanced, treatment-refractory solid tumors
A Prospective, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of CMTS1215 Injection in Subjects With Solid Tumors
This trial will test whether injections of CMTS1215, an oncolytic Proteus mirabilis bacterium, can shrink measurable solid tumors in adults who have not responded to standard therapies.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Second Hospital of Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07556276 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with histologically confirmed, measurable solid tumors who have failed or cannot receive standard first-, second-, or third-line therapies, with ECOG performance status 0–2 and expected survival greater than three months.
Not a fit: Patients with uncontrolled cardiovascular disease, active severe infections, coagulation abnormalities or those whose tumors are inaccessible for safe intratumoral injection are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could provide a new local therapy that directly kills tumor cells and stimulates anti-tumor immunity for patients with treatment-refractory solid tumors.
How similar studies have performed: Other oncolytic bacterial approaches have shown promising preclinical results and limited clinical signals, but CMTS1215 (a Proteus mirabilis strain) is a novel agent with primarily preclinical support to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nanjing, Jiangsu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.