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

NCT06695689 | Recruiting Early Phase 1

• 1 other identifier: LM303-CO-301
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events (AEs)

  Adverse events are graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

  Up to 1 years

Secondary Outcomes (4)

• Number of Participants With Objective Response

  Up to 2 years

• Disease Control Rate (DCR）

  Up to 2 years

• Progression-Free Survival (PFS)

  Up to 2 years

• The changes of the immunoreactivity during treatment

  Up to 2 years

Study Arms (1)

LM303

EXPERIMENTAL

Treatment with LM303 injection

Drug: LM303

Interventions

LM303 DRUG

Treatment with LM303 injection

LM303

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Suzhou BlueHorse Therapeutics Co., Ltd.: lead

Study Sites (1)

Tianjin Beichen Hospital

Tianjin, 300000, China

RECRUITING

Central Study Contacts

Feng e Li

CONTACT

13821072072; rosetea85@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 19, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

CN (1)