NCT05650242

A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1106 in Advanced Solid Tumors

An Non-randomized Open-label, Multicenter Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy of BA1106 in Participants With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: Shandong Boan Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open label Phase 1, First in Human trial designed to evaluate the safety, tolerability pharmacokinetics, preliminary efficacy of BA1106 in participants with advanced solid tumors.

Detailed description

BA1106 is a human anti-CD25 monoclonal antibody. There are two parts in the study. Part A is dose escalation study, and Part B is dose expansion study. Part A will be conducted using BOIN dose escalation method at the dosing regimen of once every 3 weeks. In Part B, 1\~2 dose levels, dosing regimens (i.e. once every 2 weeks or once every 3 weeks), and 1\~4 selected indications will be chosen to further evaluate the safety and efficacy of BA1106.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	BA1106	In part A, after the observation period of DLT (28 days), intravenous (IV) once every 3 weeks (Q3W). In Part B, intravenous (IV) once every 3 weeks (Q3W) or once every 2 weeks (Q2W).

Timeline

• Start date: 2023-01-31
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-12-14
• Last updated: 2024-11-08

Locations

1 site across 1 country: China