RecruitingAdvanced Solid TumorLung Squamous Cell CarcinomaHepatocellular Carcinoma
JMT106 Injection in the Treatment of Advanced Solid Tumors
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
This study is the first-in-human Phase I study of JMT106 injection, comprising two phases: Dose escalation with backfill and cohort expansion. The planned study population consists of subjects with advanced solid tumors. The objective is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of JMT106 injection as monotherapy in participants with advanced solid tumors
Sponsor: Shanghai JMT-Bio Inc.
You may qualify if…
- ✓ 1. Age ≥18 years.
- ✓ 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;
You may not qualify if…
- ✕ 1. Previous treatment with anti-GPC3 therapy.
- ✕ 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.
Source: ClinicalTrials.gov · NCT07275073 · last updated 2025-12-18