NCT04718584

the Efficacy and Safety of LDP in Patients With Urinary and Male Genital Tumors

A Single-arm, Open, Multicenter, Phase II Clinical Study of the Efficacy and Safety of Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) in the Treatment of Urinary and Male Genital Tumors

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 127 (estimated)
• Sponsor: Dragonboat Biopharmaceutical Company Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm,open, multicenter, phase II clinical study of the efficacy and safety of human anti-PD-L1 monoclonal antibody Injection (LDP) in the treatment of urinary and male genital tumors.

Detailed description

This trial is a single arm, open, multicenter, Ⅱ period clinical research. Three cohorts were included, 127 subjects were enrolled (Cohort 1: about 60 subjects with surgically suitable muscular-invasive bladder cancer; Cohort 2: about 40 subjects with advanced Non-clear Cell Renal Carcinoma; Cohort 3: about 27 subjects with advanced penile carcinoma. After confirmation of inclusion, intravenous infusion of 10mg/kg human anti-PD-L1 monoclonal antibody injection (LDP) was given. The initial efficacy and safety of drugs in different tumor species in the cohort above will be observed.

Conditions

• Bladder Cancer
• Renal Carcinoma
• Advanced Penile Carcinoma

Interventions

Type	Name	Description
DRUG	Human Anti-PD-L1 Monoclonal Antibody Injection (LDP)	All participants will receive treatment with LDP 10mg/kg once every two weeks, every 2 weeks will be a cycle. In Cort 1, surgical treatment will be performed within 2 weeks after the end of 3 cycles of treatment.

Timeline

• Start date: 2020-09-11
• Primary completion: 2022-11-01
• Completion: 2023-11-01
• First posted: 2021-01-22
• Last updated: 2021-01-22

Locations

1 site across 1 country: China