Clinical trial · Interventional
An Investigator-initiated Clinical Study of LM303 Injection for the Treatment of Advanced Solid Tumours
NCT06695689CI-TRIAL-00082702recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of LM303 Injection in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity and immunoreactivity.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LM303 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LM303
- description
- Treatment with LM303 injection
- interventionNames
- Drug: LM303
Primary outcomes (1)
- measure
- Incidence and severity of adverse events (AEs)
- timeFrame
- Up to 1 years
- description
- Adverse events are graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Secondary outcomes (4)
- measure
- Number of Participants With Objective Response
- timeFrame
- Up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. AJCC (V8) stage III or IV melanoma, non-small cell lung cancer, cervical cancer and other solid tumors (confirmed by histology) for which existing treatment is ineffective or without standard treatment; 2. The patient has residual lesions that can be used for surgical resection (\>1.5cm3) or biopsy (\>1.5cm3) and measurable after resection for TIL collection and efficacy evaluation; 3. Laboratory inspection index requirements: * Blood routine: lymphocyte ratio \> 20%; neutrophil count \> 1.0 × 10\^9/L; white blood cells \> 3.0 × 10\^9/L; platelets \> 100 × 10\^9/L; hemoglobin \> 80 g/ L; * Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ upper limit of normal x 2.5, if there is liver metastasis ≤ upper limit of normal x 5; alkaline phosphatase (ALP) ≤ upper limit of normal x 2.5; total gallbladder Red pigment (TBIL)≤normal upper limit×1.5; * Renal function: urea ≤ upper limit of normal × 1.5; creatinine (Cr) ≤ upper limit of normal × 1.5; 4. Left ventricular ejection fraction (LVEF) ≥ 50%; 5. ECOG physical condition is 0 or 1; 6. The expected survival time is more than 3 months; Exclusion Criteria: 1. Suffering from active or previous autoimmune diseases ; 2. Severe liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and hematopoietic dysfunction; 3. Combined with severe infection or persistent infection and cannot be effectively controlled; 4. Central nervous system metastasis and/or cancerous meningitis; 5. With uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage; 6. Requires systemic steroid therapy; 7. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb); positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis;
References
Publications (0)
Data not yet available
No reference posted for this study.