Trials / Completed
CompletedNCT05223231
Evaluation of LBL-019 Monotherapy or Combined With Anti-PD-1 Antibody in the Treatment of Advanced Malignant Tumors
A Multicenter, Open Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LBL-019 Monotherapy or Combination Anti-PD-1 Antibody in Patients With Advanced Malignant Tumors
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Nanjing Leads Biolabs Co.,Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This trial is a phase I/II study, which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors.
Detailed description
This trial is a phase I/II study , which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors. Approximately 244-486 subjects with advanced malignant tumors will be enrolled. The study was divided into two phases: Phase I (Part A single therapy dose escalation and Part B combination therapy dose escalation) and Phase II (Part A single therapy dose expansion and Part B combination therapy dose expansion) .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LBL-019 Injection | initial dose-MTD |
| DRUG | anti-PD-1 antibody injection | provide medicine base on needs |
Timeline
- Start date
- 2022-04-19
- Primary completion
- 2024-08-09
- Completion
- 2024-08-09
- First posted
- 2022-02-03
- Last updated
- 2026-02-02
Locations
6 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05223231. Inclusion in this directory is not an endorsement.