NCT05405621

Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009

A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009 in Patients With Advanced Solid Tumours

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Primary objectives: * To evaluate the safety and tolerability of BAT8009 in patients with advanced solid tumours. * To determine the maximum tolerated dose (MTD) and recommended dose for Phase 2 (RP2D).

Detailed description

This is a first-in-human (FIH), multicentre, open-label, Phase 1 dose escalation and dose expansion study of BAT8009 (a B7H3-targeting antibody-drug conjugate) in patients with advanced solid tumours.

Conditions

• Locally Advanced/Metastatic Solid Tumours

Interventions

Type	Name	Description
DRUG	BAT8009 for Injection	BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30\~120 minutes.

Timeline

• Start date: 2022-08-02
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2022-06-06
• Last updated: 2022-10-27

Locations

1 site across 1 country: China