Recruiting NCT06695689
An Investigator-initiated Clinical Study of LM303 Injection for the Treatment of Advanced Solid Tumours
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LM303.
- Who it may be relevant to
- Registry conditions: Solid Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug LM303
Treatment with LM303 injection
Primary outcome measures
- Incidence and severity of adverse events (AEs) [Time frame: Up to 1 years]
Secondary outcome measures (4)
- Number of Participants With Objective Response [Time frame: Up to 2 years]
- Disease Control Rate (DCR） [Time frame: Up to 2 years]
- Progression-Free Survival (PFS) [Time frame: Up to 2 years]
- The changes of the immunoreactivity during treatment [Time frame: Up to 2 years]
Eligibility criteria
Inclusion criteria
- 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;
- 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;
- 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;
- Left ventricular ejection fraction (LVEF) ≥ 50%;
- ECOG physical condition is 0 or 1;
- The expected survival time is more than 3 months;
Exclusion criteria
- Suffering from active or previous autoimmune diseases ;
- Severe liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and hematopoietic dysfunction;
- Combined with severe infection or persistent infection and cannot be effectively controlled;
- Central nervous system metastasis and/or cancerous meningitis;
- With uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
- Requires systemic steroid therapy;
- 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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tianjin Beichen Hospital — Tianjin
Identifiers
NCT: NCT06695689 · LM303-CO-301