Solid TumorPhase 1/2NCT07556276
Study of CMTS1215 Injection in Patients With Solid Tumors
A Phase 1/2 study testing CMTS1215 Oncolytic Bacteria in people with Solid Tumor, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- CMTS1215 Oncolytic Bacteria
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2025to 31 Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older, any gender
- Histologically confirmed solid tumor with measurable lesions according to RECIST 1.1
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Expected survival time > 3 months 6 Voluntary participation with signed informed consent
Who cannot join
- Uncontrolled cardiovascular disease (e.g., heart failure NYHA III-IV, coronary artery disease, cardiomyopathy, arrhythmia)
- Active severe clinical infection (> Grade 2 NCI-CTCAE v5.0), including fungal, viral, or tuberculosis infection
- 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)
- History of immunodeficiency, acquired or congenital immunodeficiency diseases, or organ transplantation
- Lactating female patients
- Currently participating in other clinical studies
Show all 10Show fewer
- Women of childbearing potential planning pregnancy during the study period
- Patients with allergies to common antibiotics
- Patients lacking or with restricted legal capacity
- Other patients deemed unsuitable for enrollment by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Faming Zhang, MD, PhD, 086-25-58509883, fzhang@njmu.edu.cn
About this study
Official title: A Prospective, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of CMTS1215 Injection in Subjects With Solid Tumors
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.
Read the 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.
- Conditions
- Solid Tumor
- Being tested
- CMTS1215 Oncolytic Bacteria
- Keywords
- Solid tumor, Advanced cancer, Treatment-refractory cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMTS1215 Oncolytic BacteriaBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| CMTS1215 Treatment Group | Experimental | 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. Receives: Biological: CMTS1215 Oncolytic Bacteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) as Assessed by RECIST v1.1
Proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST v1.1 criteria.
Measured: 1 week, 4 weeks,
Incidence and Severity of Treatment-Emergent Adverse Events [Safety and Tolerability]
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.
Measured: 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
Secondary outcomes (3)
Progression-Free Survival (PFS) as Assessed by RECIST v1.1
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.
Measured: From first dose through 12 months, or until disease progression/death
Overall Survival (OS) Defined as Time from First Dose to Death from Any Cause
Time from first dose of CMTS1215 to death from any cause. Participants alive at last contact will be censored at that date.
Measured: From first dose through 12 months
CMTS1215 DNA Load in Tumor Tissue as Quantified by Strain-Specific qPCR
Absolute quantification of CMTS1215-specific genomic DNA in tumor biopsy samples by qPCR, expressed as log₁₀ copies per microgram of tissue DNA.
Measured: Baseline and up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start6 Mar 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faming Zhang, The Second Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556276
- Sponsor's protocol ID
- CMTS1215-ST
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of CMTS1215 Injection in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT07556276
- Acronym / sponsor ID
- CMTS1215-ST
- Conditions
- Solid Tumor
- Keywords
- Solid tumor, Advanced cancer, Treatment-refractory cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMTS1215 Treatment Group | Experimental | Biological: CMTS1215 Oncolytic BacteriaAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older, any gender
- Histologically confirmed solid tumor with measurable lesions according to RECIST 1.1
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Expected survival time > 3 months 6 Voluntary participation with signed informed consent
Key exclusion criteria (10 listed)
- Uncontrolled cardiovascular disease (e.g., heart failure NYHA III-IV, coronary artery disease, cardiomyopathy, arrhythmia)
- Active severe clinical infection (> Grade 2 NCI-CTCAE v5.0), including fungal, viral, or tuberculosis infection
- 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)
- History of immunodeficiency, acquired or congenital immunodeficiency diseases, or organ transplantation
- Lactating female patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMTS1215 Oncolytic BacteriaCMTS1215 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. | Biological | CMTS1215 Treatment Group |
Primary outcome
Objective Response Rate (ORR) as Assessed by RECIST v1.1
Time frame: 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]
Time frame: 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.
3 secondary outcomes
Progression-Free Survival (PFS) as Assessed by RECIST v1.1
Time frame: From first dose through 12 months, or until disease progression/death
Overall Survival (OS) Defined as Time from First Dose to Death from Any Cause
Time frame: From first dose through 12 months
CMTS1215 DNA Load in Tumor Tissue as Quantified by Strain-Specific qPCR
Time frame: Baseline and up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CMTS1215 Oncolytic Bacteria in people with Solid Tumor, run by The Second Hospital of Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Faming Zhang, MD, PhD (086-25-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) as Assessed by RECIST v1.1 (time frame: 1 week, 4 weeks,). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.