NCT05877924

A Study of NBL-020 Injection in Subjects With Advanced Malignant Tumors.

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Anti-tumor Activity of NBL-020 Injection in Subjects With Advanced Malignant Tumors.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: NovaRock Biotherapeutics, Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety and tolerability of NBL-020 injection in subjects with advanced malignant tumors, and determine the dose limiting toxicity (DLT), maximum tolerable dose (MTD) (if any), recommended phase II dose (RP2D), and dosing regimen of NBL-020.

Detailed description

The study is divided into two parts: dose escalation and dose expansion. Dose increasing study: The initial dose for the dose escalation study is 0.1 mg/kg administered once every 3 weeks (Q3W), with a pre-set maximum escalation dose of 30 mg/kg Q3W. Safety Management Committee (SMC) can jointly discuss and determine whether to proceed with a higher dose group or increase additional doses or different dosing intervals between two adjacent dose groups (such as Q2W or Q4W) based on the safety, tolerance, efficacy, PK, PD, and related biomarker data of each dose group. Dose expansion study: Based on the results of the dose escalation study, the dosage for the dose extension study will be determined through joint discussion between the sponsor and the investigators. If necessary, multiple doses can be selected for dose extension.

Conditions

• Advanced Malignant Tumors

Interventions

Type	Name	Description
DRUG	NBL-020 for Injection	NBL-020 for Injection, Q3W, i.v.

Timeline

• Start date: 2023-08-15
• Primary completion: 2025-08-01
• Completion: 2026-12-01
• First posted: 2023-05-26
• Last updated: 2024-03-26

Locations

1 site across 1 country: China