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A Phase Ib/II Clinical Trial of LBL-007 Combined With Tislelizumab in the Treatment of Malignant Tumors

NCT05516914 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

  • Malignant Tumors

Interventions

DRUG

LBL-007 Injection

Initial dose - MTD; Q3W; intravenous infusion

DRUG

Tislelizumab Injection

Initial dose; Q3W; intravenous infusion

DRUG

Cisplatin Injection

Initial dose；Q3W; intravenous infusion

DRUG

Gemcitabine Hydrochloride for Injection

Initial dose；Q3W; intravenous infusion

DRUG

Docetaxel injection

Initial dose；Q3W; intravenous infusion

Sponsors & Collaborators

  • Nanjing Leads Biolabs Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • li zhang · Sun Yat-Sen University Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2026-01-30
Completion
2026-01-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05516914 on ClinicalTrials.gov