Solid Tumor
Conditions
Keywords
Solid tumor, Advanced cancer, Treatment-refractory cancer
Brief 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.
Detailed description
Oncolytic bacteria are a class of bacteria that can specifically reproduce within tumors and cause tumor cell death while activating the host immune system. CMTS1215 is a Proteus mirabilis strain developed by the research team with demonstrated oncolytic effects in preclinical studies. The bacteria show excellent tumor tropism and have been shown to be safe and effective in mouse and canine models. This study will evaluate the tumor response rate at 1 week and 4 weeks post-treatment according to RECIST 1.1 criteria, as well as assess the safety profile of the treatment. Patients will receive intratumoral injection of CMTS1215 under direct visualization or endoscopic guidance for up to 6-8 treatment cycles.
Interventions
BIOLOGICALCMTS1215 Oncolytic Bacteria
CMTS1215 is a bacterial therapeutic preparation designated with the code CMTS1215. The mechanism of action may involve bacterial membrane proteins that facilitate tumor-targeting properties. CMTS1215 is administered via intratumoral injection (under direct visualization or endoscopic guidance) or intravenous injection, with dosage calculated based on tumor size.
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) as Assessed by RECIST v1.1 | 1 week, 4 weeks, | Proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST v1.1 criteria. |
| Incidence and Severity of Treatment-Emergent Adverse Events [Safety and Tolerability] | From informed consent through 6 months after the last dose of CMTS1215, or until resolution of any ongoing treatment-related adverse events, whichever is longer | Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to dose modification or discontinuation, graded by CTCAE v5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) as Assessed by RECIST v1.1 | From first dose through 12 months, or until disease progression/death | Time from first dose of CMTS1215 to radiographic disease progression or death from any cause, whichever occurs first, based on investigator assessment per RECIST v1.1 criteria. |
| Overall Survival (OS) Defined as Time from First Dose to Death from Any Cause | From first dose through 12 months | Time from first dose of CMTS1215 to death from any cause. Participants alive at last contact will be censored at that date. |
| CMTS1215 DNA Load in Tumor Tissue as Quantified by Strain-Specific qPCR | Baseline and up to 3 months | Absolute quantification of CMTS1215-specific genomic DNA in tumor biopsy samples by qPCR, expressed as log₁₀ copies per microgram of tissue DNA. |
Countries
China
Contacts
CONTACTFaming Zhang, MD, PhD
Outcome results
None listed