Study of CMTS1215 Injection in Patients With Solid Tumors

NCT07556276 | Recruiting Phase 1 DMC

• 1 other identifier: CMTS1215-ST
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Keywords

Solid tumor; Advanced cancer; Treatment-refractory cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  From first dose through 12 months

• CMTS1215 DNA Load in Tumor Tissue as Quantified by Strain-Specific qPCR

  Baseline and up to 3 months

Study Arms (1)

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.

Biological: CMTS1215 Oncolytic Bacteria

Interventions

CMTS1215 Oncolytic Bacteria BIOLOGICAL

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.

CMTS1215 Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210011, China

RECRUITING

Central Study Contacts

Faming Zhang, MD, PhD

CONTACT

086-25-58509883; fzhang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Gastroenterology

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: April 29, 2026
• Study Start: March 6, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)