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

Study Overview
=================
Brief Summary
-----------------
A phase I clinical study evaluating LBL-003 in the treatment of subjects with advanced solid tumors .

Detailed Description
-----------------
This study is a phase I clinical study evaluating LBL-003 monotherapy in patients with advanced solid tumors in dose escalation. The overall design of the study is shown in the figure below. The purpose of the LBL-003 single-dose escalation study in subjects with advanced solid tumors is to evaluate the safety and tolerability of monotherapy to determine the MTD (or MAD) and clinically recommended doses of LBL-003 monotherapy.

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

Conditions
-----------------
Advanced Solid Tumor

Intervention / Treatment
-----------------
* Drug: LBL-003Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both male and female aged Age ≥ 18 and ≤ 75; ECOG score: 0-1; The subjects voluntarily participate in the study, sign the Informed Consent Form, with good compliance, and can cooperate with the follow-up. 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. Subjects should have at least one evaluable lesion as defined by RECIST V1.1;Expected survival period ≥ 3 months; Exclusion Criteria: 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. 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); Have received major surgery within 4 weeks before the first administration; Subjects can not tolerate intravenous administration and have difficulty in venous blood collection (if there is a history of fainting needles and bleeding); Women during pregnancy or lactation;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A phase I clinical study evaluating LBL-003 in the treatment of subjects with advanced solid tumors<br>Drug: LBL-003Injection The test drugLBL-003will be preset with 6 escalation dose levels: dose A, dose B, dose C, dose D and dose E, dose F , administered twice a week. | Drug: LBL-003Injection<br>* LBL-003 was given every two weeks for treatment<br>* Other names: LBL-003;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjcects with adverse events and serious adverse events | The safety profile of LBL-003 will be assessed by monitoring the adverse event(AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE)v5.0 | 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) | MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first two cycles. | During the first two Cycles(each cycle is 14 days) | 
| Dose-limiting toxicities | DLT is defined as a toxicities(adverse event at least possibly related to LBL-003 )occurring during the DLT observation period(the initial 28 days). | During the first two Cycles(each cycle is 14 days) |