Clinical trial

Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-003 Injection in Patients With Advanced Malignancies

NCT05042908

Name

LBL-003-CN-001

Description

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

Trial arms

Trial start

2021-11-15

Estimated PCD

2024-03-22

Trial end

2024-07-22

Status

Recruiting

Phase

Early phase I

Treatment

LBL-003Injection

LBL-003 was given every two weeks for treatment

Arms:

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

Other names:

LBL-003

Size

Primary endpoint

Number of subjcects with adverse events and serious adverse events

All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30±7 days after drug withdrawal or before the start of new anti-tumor therapy) ]

Maximum tolerated dose (MTD)

During the first two Cycles(each cycle is 14 days)

Dose-limiting toxicities

During the first two Cycles(each cycle is 14 days)

Eligibility 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;

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}

Updated at

2024-01-05

1 organization

1 product

1 indication

Organization

Nanjing Leads Biolabs

Product

LBL-003Injection

Indication

Advanced Solid Tumor