CI

At a glance

ClinicalIndex Comparison Record
Phase 1Unknown· 48 target
Drug / intervention
BAT8009 for Injectiondrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05405621
NCT05405621Phase 1Unknown

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

Bio-Thera Solutions·interventional·Posted Jun 6, 2022·Updated Oct 27, 2022

In Brief

A Phase 1 clinical trial evaluating BAT8009 for Injection for Locally Advanced/Metastatic Solid Tumours. Targeting 48 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 1UnknownOverdue
2023202420252026
First PostedJun 6, 2022
Enrollment StartAug 2, 2022
Primary CompletionDec 1, 2023
Study CompletionDec 1, 2024
TodayJul 1, 2026
Enrollment to primary: 1.3 yearsPosted 4.1 years ago

Interventions

BAT8009 for Injectiondrug

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.