A Phase 1/2 interventional study of LBL-007 Injection and Tislelizumab Injection in Malignant Tumors, sponsored by Nanjing Leads Biolabs Co.,Ltd. Completed at 15 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Nanjing Leads Biolabs Co.,Ltd · Phase 1/2, Interventional, and Treatment
This trial is an open and multicenter phase Ib/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.
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)
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 98 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Nanjing Leads Biolabs Co.,Ltd is the lead sponsor of 20 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
LBL-007 Injection; dose A or dose B; Q3W
Drug: LBL-007 Injection · Drug: Tislelizumab Injection · Drug: Cisplatin Injection · Drug: Gemcitabine Hydrochloride for Injection · Drug: Docetaxel injection
Initial dose - MTD; Q3W; intravenous infusion
Also known as: LBL-007
Initial dose; Q3W; intravenous infusion
Also known as: Tislelizumab
Initial dose；Q3W; intravenous infusion
Also known as: Cisplatin
Initial dose；Q3W; intravenous infusion
Also known as: Gemcitabine Hydrochloride
Initial dose；Q3W; intravenous infusion
Also known as: Docetaxel
Objective Response Rate (ORR)
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
Time frame: 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
Dose-limiting toxicities（DLT）
DLT is defined as toxicity during the DLT observation period (3 weeks after the first dose).
Time frame: 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
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 cycles
Time frame: At the end of Cycle 1 (each cycle is 21days)
Cmax
Maximum serum concentration
Time frame: 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)
immunogenicity
The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects
Time frame: 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)
Disease Control Rate(DCR)
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).
Time frame: 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)
Duration of Response(DOR)
To measure duration of response
Time frame: 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)
Tmax
After taking a single dose, Time to reach maximum plasma concentration
Time frame: 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)
Plan to share: No
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Nanjing Leads Biolabs Co.,Ltd