NCT05153096

Evaluation of the Safety and Efficacy of NBL-015 in Patients With Advanced Solid Tumors

A Phase I, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of NBL-015 in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: NovaRock Biotherapeutics, Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is an open-label, multicenter, dose-escalation and cohort-expansion Phase I clinical study in patients with advanced solid tumors. The aim of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of NBL-015 in patients with advanced solid tumors.

Detailed description

This study is a multicenter, open-label phase I clinical trial conducted in patients with CLDN18.2-positive advanced solid tumors, aiming to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of NBL-015 in patient with advanced solid tumors. This study consists of two stages: the stage I (dose escalation and dose expansion) and the stage II (NBL-015 monotherapy cohort expansion and combination of NBL-015 with standard treatment cohort expansion). The dose escalation phase is divided into 5 dose levels. NBL-015 is escalated in order of 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg until MTD. If MTD is still not observed in the preset highest dose group, the investigator and the sponsor can jointly decide whether to conduct a higher dose group study. If necessary, intermediate doses may be conducted. The first dose group (1 mg/kg) is the accelerated titration group, in which 1 patient will be enrolled, and the "3+3" dose escalation design will be followed from the second dose group. If RP2D can be determined based on clinical study data in the dose escalation stage, Stage II cohort expansion will be directly conducted. Alternatively, based on the safety, tolerability and efficacy data obtained from dose-escalation studies, dose expansion and different dosing can be explored if necessary. Based on available PK and clinical efficacy data, appropriate dose groups will be selected for cohort expansion. The cohort expansion stage includes the NBL-015 monotherapy cohort expansion trial and the combination of NBL-015with standard treatment cohort expansion trial.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	NBL-015	NBL-015 by intravenous infusion

Timeline

• Start date: 2022-04-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-12-10
• Last updated: 2022-01-03

Locations

1 site across 1 country: China