First-in-Human Investigation of JMT108 Injection in Participants With Advanced Malignant Tumors

Exclusion Criteria

• •1. Any other unapproved investigational drugs or treatments within 4 weeks prior to the first dose of the investigational drug (C1D1).
• •2. Chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor therapies within 4 weeks prior to the first dose of the investigational drug, except in the following situations:
• •Nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational drug; Use of oral fluoropyrimidines and small-molecule targeted drugs within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to the first dose of the investigational drug; Use of herbal medicine/products with anti-tumor indications within 2 weeks prior to the first dose of the investigational drug.
• •3. Major surgery (excluding biopsy) or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug, or plan to do major surgery during the study period.
• •4. Systemic corticosteroids or other immunosuppression therapy within 14 days prior to the first dose of the investigational drug. Except for the following situations: use of physiological replacement doses of hydrocortisone or other equivalent doses of hormones (i.e., prednisone ≤10 mg/day or other equivalent doses of hormones); use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroid therapy; use of short-course glucocorticoids for prophylaxis (e.g., prevention of contrast allergy).
• •5. Live vaccines within 4 weeks prior to the first dose of investigational drug. Note: Seasonal influenza vaccines are inactivated vaccines in a broad sense and are allowed. Intranasal influenza vaccines are live vaccines and are not permitted.
• •6. History of hematopoietic stem cell transplant or organ transplant.
• •7. AEs from prior therapy which have not recovered to Grade ≤1 or baseline as per NCI CTCAE v5.0 (excluding toxicities evaluated by the investigator to have no safety risk, such as alopecia, Grade 2 peripheral neurotoxicity, hypothyroidism stabilized with hormone replacement therapy, etc.).
• •8. Active central nervous system metastases and/or leptomeningeal metastases. Participants with brain metastases who have confirmed progression-free status by imaging examinations for at least 4 weeks after treatment and who have not required hormonal or antiepileptic therapy for at least 2 weeks may be considered for enrollment.
• •9. History of interstitial lung disease or pneumonitis.
• •10. History of serious cardiovascular and cerebrovascular diseases.
• •11. Active or recurrent autoimmune diseases (such as systemic lupus erythematosus, arthritis, vasculitis, etc.).
• •12. History of Grade ≥3 immune-related AE or Grade ≥2 immune-related myocarditis considered related to prior immune modulatory therapytherapy.
• •13. Hemorrhage of Grade ≥2 as per NCI CTCAE v5.0 within 4 weeks prior to the first dose of the investigational drug.
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