Treatment of advanced solid tumors with LM303 injection

An Investigator-initiated Clinical Study of LM303 Injection for the Treatment of Advanced Solid Tumours

This study is testing a new injection called LM303 to see if it can help people with advanced solid tumors, like melanoma and lung cancer, who haven't had success with other treatments.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Tianjin)
• Trial ID: NCT06695689 on ClinicalTrials.gov

What this trial studies

This is an exploratory, single-arm, open-label study aimed at evaluating the safety and efficacy of LM303 injection in patients with advanced solid tumors. The study focuses on patients with stage III or IV melanoma, non-small cell lung cancer, cervical cancer, and other solid tumors that have not responded to existing treatments. Participants will undergo assessments for safety, tolerability, antitumor activity, and immunoreactivity, with measurable lesions available for evaluation. The study aims to gather preliminary data on the potential benefits of LM303 in this patient population.

Who should consider this trial

Good fit: Ideal candidates include patients with stage III or IV solid tumors who have residual lesions suitable for surgical resection or biopsy and have not responded to standard treatments.

Not a fit: Patients with early-stage tumors or those who have not yet exhausted standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: While this approach is exploratory, similar studies targeting advanced solid tumors with novel therapies have shown promise in the past.

Eligibility criteria

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;

Where this trial is running

Tianjin

• Tianjin Beichen Hospital — Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Feng e Li

Conditions Solid Tumor