Malignant Tumors
Conditions
Brief summary
This trial is an open and multicenter phase Ib/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.
Detailed description
This is an open, multicenter Phase Ib/II clinical trial of LBL-007 combined with Tislelizumab in the treatment of malignant tumors，which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness. The study was divided into two phases: Phase Ib (Part A): Dose escalation and PK expansion; Phase II includes: Part B, Part C, Part D, Part E, Part F, Part G, Part H. Part B \ Part H will be designed and conducted based on the safety , tolerability and PK analysis of the Part A Study Part, after RP2D is determined, will be used for Part B \ Part H cohort. Approximately 250-490 subjects will be enrolled (Specific sample size shall be subject to actual occurrence)
Interventions
Initial dose - MTD; Q3W; intravenous infusion
Initial dose; Q3W; intravenous infusion
DRUGCisplatin Injection
Initial dose；Q3W; intravenous infusion
DRUGGemcitabine Hydrochloride for Injection
Initial dose；Q3W; intravenous infusion
DRUGDocetaxel injection
Initial dose；Q3W; intravenous infusion
Sponsors
Nanjing Leads Biolabs Co.,Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form; 2. Age ≥ 18 and ≤ 75 years old when signing the informed consent form, regardless of gender; 3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) PS is 0\~1; 4. The expected survival time is at least 12 weeks; 5. According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), the subjects enrolled have at least one measurable tumor lesion; 6. Subject has adequate organ and bone marrow function 7. Males with fertility and females of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception from the signing of the informed consent form to 6 months after the last administration of the trial drug Sets, etc.); women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.
Exclusion criteria
1. Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time; 2. Those who have clinically uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage or medical intervention; 3. Women during pregnancy or lactation; 4. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study. 5. Patients with history of severe cardiovascular and cerebrovascular diseases. 6. Patients with active infection and currently requiring intravenous anti-infective treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 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 | ORR (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST), refers to the percentage of study subjects who achieve a complete response or partial response |
| Dose-limiting toxicities（DLT） | DLT is defined as toxicity during the DLT observation period. The duration of DLT observation period is from the first dose to 3 weeks after the first dose | DLT is defined as toxicity during the DLT observation period (3 weeks after the first dose). |
| Maximum tolerated dose (MTD) | At the end of Cycle 1 (each cycle is 21days) | MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycles |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 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 serum concentration |
| immunogenicity | 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) | The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects |
| Disease Control Rate(DCR) | 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) | DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD). |
| Duration of Response(DOR) | 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) | To measure duration of response |
| Tmax | 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) | After taking a single dose, Time to reach maximum plasma concentration |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORli zhang
Sun Yat-Sen University Cancer Center
Outcome results
None listed