Evaluation of LBL-003 Phase I Study in Patients With Advanced Malignancies

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

A phase I clinical study evaluating LBL-003 in the treatment of subjects with advanced solid tumors .

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing Leads Biolabs Co.,Ltd

Criteria

Inclusion Criteria:

1. Both male and female aged Age ≥ 18 and ≤ 75;

2. ECOG score: 0-1;

3. The subjects voluntarily participate in the study, sign the Informed Consent Form, with good compliance, and can cooperate with the follow-up.

4. Subjects with advanced malignant solid tumors confirmed by histology or cytology have failed the standard treatment or have no standard treatment protocol or are not suitable for standard treatment at this stage.

5. Subjects should have at least one evaluable lesion as defined by RECIST V1.1;Expected survival period ≥ 3 months;

Exclusion Criteria:

1. Persons with known hypersensitivity to any of the active ingredients or excipients of LBL-003 Injection or a history of atopic allergic reactions (asthma, rheumatism, eczematous dermatitis) who, in the judgment of the investigator, are not suitable for treatment with the test drug.

2. Subjects with active central nervous system metastases (regardless of whether they have received treatment), including symptomatic brain metastases, meningeal metastases, or spinal cord compression, but asymptomatic brain metastases (no progression and/or at least 4 weeks after radiotherapy) No neurological symptoms or signs after surgical resection, and dexamethasone or mannitol treatment is not required);

3. Have received major surgery within 4 weeks before the first administration;

4. Subjects can not tolerate intravenous administration and have difficulty in venous blood collection (if there is a history of fainting needles and bleeding);

5. Women during pregnancy or lactation;