JMT106 Injection in the Treatment of Advanced Solid Tumors

Exclusion Criteria28

• Previous treatment with anti-GPC3 therapy.
• 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.
• 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.
• 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).
• 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.
• Grade ≥3 immune-related adverse events (irAEs, per CTCAE 5.0) from prior immunotherapy.
• Concurrent participation in another interventional clinical trial (observational trials or follow-up phases allowed).
• Major surgery within 28 days before the first dose or planned tumor resection during the study.
• 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.
• Known severe allergy to the study drug or its excipients.
• 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.
• Uncontrolled effusions (pleural, peritoneal, pericardial) requiring frequent drainage or intervention within 14 days before the first dose (excluding cytologic evaluation of effusions).
• History of allogeneic organ or hematopoietic stem cell transplantation.
• Immunodeficiency, including HIV-positive status.
• HBsAg-positive or HBcAb-positive with HBV-DNA \>2000 IU/mL; HCV antibody-positive with HCV-RNA positivity.
• History of tuberculosis treatment within 2 years before the first dose.
• Interstitial lung disease or severe pulmonary dysfunction.
• History of inflammatory bowel disease or chronic diarrhea.
• Severe cardiovascular/cerebrovascular disease, including:
• Severe arrhythmias/conduction abnormalities (e.g., ventricular arrhythmias requiring intervention, AV block grade II-III);
• Acute coronary syndrome, congestive heart failure, stroke, or other Grade ≥3 cardiovascular events within 6 months before the first dose;
• NYHA class ≥II or LVEF \<50%;
• Long QTc syndrome or QTc \>480 ms (Fridericia formula), or concomitant use of QTc-prolonging drugs;
• Uncontrolled hypertension (systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg at screening).
• 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).
• Live vaccination within 28 days before the first dose (inactivated vaccines, e.g., seasonal flu vaccine, allowed).
• Pregnancy or lactation.
• Other conditions deemed unsuitable by the investigator (e.g., depression history/current treatment, psychiatric disorders affecting compliance, main portal vein tumor thrombus).