Clinical trial · Interventional
Study of CMTS1215 Injection in Patients With Solid Tumors
A Prospective, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of CMTS1215 Injection in Subjects With Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CMTS1215 Oncolytic Bacteria | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CMTS1215 Treatment Group
- description
- All enrolled patients will receive CMTS1215 oncolytic bacteria. The dose will be calculated based on tumor size (for intratumoral route) or body weight (for intravenous route). Treatment will be administered via either intratumoral injection (under direct visualization or endoscopic guidance) or intravenous injection for 6-8 cycles. The route of administration will be determined by the investigator based on tumor characteristics and patient condition.
- interventionNames
- Biological: CMTS1215 Oncolytic Bacteria
Primary outcomes (2)
- measure
- Objective Response Rate (ORR) as Assessed by RECIST v1.1
- timeFrame
- 1 week, 4 weeks,
- description
- Proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST v1.1 criteria.
- measure
- Incidence and Severity of Treatment-Emergent Adverse Events [Safety and Tolerability]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available