JMT106 Injection in the Treatment of Advanced Solid Tumors
NCT ID: NCT07275073
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
200 participants
INTERVENTIONAL
2025-09-25
2028-11-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
JMT106 injection as single agent
JMT106 Injection
Use according to the protocol.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
JMT106 Injection
Use according to the protocol.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Histologically or cytologically confirmed advanced solid tumor.
3. Failure of at least one line of standard therapy, or no standard treatment available, or intolerant to standard treatment at the current stage.
4. At least one measurable lesion according to RECIST 1.1 criteria.
5. ECOG performance status of 0-1.
6. Expected survival ≥3 months.
7. Sufficient organ function, with laboratory tests meeting the following criteria (no blood transfusion or hematopoietic growth factor treatment within 14 days):
1. Absolute neutrophil count (ANC) ≥1.5×10⁹/L;
2. Platelets (PLT) ≥90×10⁹/L;
3. Hemoglobin (Hb) ≥90 g/L;
4. Total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN for liver metastases or hepatocellular carcinoma);
5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN for liver metastases or hepatocellular carcinoma);
6. Creatinine clearance (Ccr) \>50 mL/min (calculated by Cockcroft-Gault formula);
7. Activated partial thromboplastin time (APTT) ≤1.5×ULN; INR ≤1.5×ULN.
8. Fertile participants (male and female) must agree to use reliable contraception (hormonal, barrier, or abstinence) with their partners during the trial and for at least 180 days after the last dose. Female participants of childbearing potential must have a negative blood pregnancy test within 7 days before enrollment.
9. Understand and voluntarily sign the informed consent form (ICF).
Exclusion Criteria
2. Presence of spinal cord compression or clinically active central nervous system metastases (untreated or symptomatic metastases, or those requiring corticosteroids/anticonvulsants for symptom control), or carcinomatous meningitis. Patients with previously treated brain metastases (e.g., whole-brain radiotherapy or stereotactic brain radiotherapy) may be enrolled if clinically stable for ≥4 weeks with no imaging evidence of progressive brain metastases.
3. Long-term immunosuppressive therapy (e.g., cyclosporine) or daily systemic steroid therapy (e.g., \>20 mg prednisone or equivalent), excluding those using nasal spray, inhaled, or other topical glucocorticoid therapies.
4. Adverse reactions from prior antitumor therapy not recovered to CTCAE 5.0 Grade ≤1 (excluding toxicities deemed non-risky by the investigator, e.g., alopecia).
5. Any antitumor therapy (chemotherapy, targeted therapy, immunotherapy, etc.) or investigational intervention within 4 weeks or 5 half-lives (whichever is shorter) before the first dose, or traditional Chinese medicine with antitumor indications within 14 days prior.
6. Grade ≥3 immune-related adverse events (irAEs, per CTCAE 5.0) from prior immunotherapy.
7. Concurrent participation in another interventional clinical trial (observational trials or follow-up phases allowed).
8. Major surgery within 28 days before the first dose or planned tumor resection during the study.
9. Significant bleeding tendency within 4 weeks before the first dose, or high-risk conditions (e.g., gastrointestinal hemorrhage, severe hemoptysis) per investigator judgment; hereditary bleeding disorders.
10. Known severe allergy to the study drug or its excipients.
11. Active bacterial, fungal, or viral infection requiring IV treatment within 14 days before randomization (prophylactic therapy allowed if no active infection symptoms); patients with viral hepatitis are allowed to receive antiviral treatment.
12. Uncontrolled effusions (pleural, peritoneal, pericardial) requiring frequent drainage or intervention within 14 days before the first dose (excluding cytologic evaluation of effusions).
13. History of allogeneic organ or hematopoietic stem cell transplantation.
14. Immunodeficiency, including HIV-positive status.
15. HBsAg-positive or HBcAb-positive with HBV-DNA \>2000 IU/mL; HCV antibody-positive with HCV-RNA positivity.
16. History of tuberculosis treatment within 2 years before the first dose.
17. Interstitial lung disease or severe pulmonary dysfunction.
18. History of inflammatory bowel disease or chronic diarrhea.
19. Severe cardiovascular/cerebrovascular disease, including:
1. Severe arrhythmias/conduction abnormalities (e.g., ventricular arrhythmias requiring intervention, AV block grade II-III);
2. Acute coronary syndrome, congestive heart failure, stroke, or other Grade ≥3 cardiovascular events within 6 months before the first dose;
3. NYHA class ≥II or LVEF \<50%;
4. Long QTc syndrome or QTc \>480 ms (Fridericia formula), or concomitant use of QTc-prolonging drugs;
5. Uncontrolled hypertension (systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg at screening).
20. Other active malignancies within 2 years (except cured localized tumors, e.g., basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer, in situ prostate/cervical/breast cancer).
21. Live vaccination within 28 days before the first dose (inactivated vaccines, e.g., seasonal flu vaccine, allowed).
22. Pregnancy or lactation.
23. Other conditions deemed unsuitable by the investigator (e.g., depression history/current treatment, psychiatric disorders affecting compliance, main portal vein tumor thrombus).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai JMT-Bio Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affilicated Hospital,Zhejiang University School of Medicine
Zhejiang, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Liang bo
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JMT106-001
Identifier Type: -
Identifier Source: org_study_id