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

NCT05405621 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-10-27

No results posted yet for this study

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).

Conditions

  • Locally Advanced/Metastatic Solid Tumours

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Li Zhang, M.D, Ph.D · Sun Yat-sen University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-02
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05405621 on ClinicalTrials.gov