NCT04151329

A Phase I Clinical Trial of BAT1306 and BAT8001 Injection in Patients With Solid Tumor

Evaluation for the Safety of BAT1306 and BAT8001 Injection for the Treatment of Patients With HER2-positive Advanced Solid Tumors Phase I/IIa Clinical Trials of Sexual, Tolerability and Pharmacokinetic Characteristics

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase I Clinical Trial of BAT1306 and BAT8001 Injection in Patients With HER2-positive Advanced Solid Tumor

Detailed description

main purpose: To evaluate the safety and tolerability of BAT8001 in combination with BAT1306 in patients with HER2-positive advanced solid tumors, and to explore the maximum tolerated dose (MTD) to determine the recommended dose for phase II clinical trials (RP2D). Secondary purpose: (1) Evaluation of pharmacokinetic (PK) and immunogenic characteristics of BAT8001 in combination with BAT1306. (2) Preliminary evaluation of the antitumor efficacy of BAT8001 in combination with BAT1306. Exploratory purpose: To explore the efficacy-related biomarkers of BAT8001 in combination with BAT1306 in the treatment of patients with advanced solid tumors.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	BAT1306 and BAT8001 2.4mg/kg	Phase 1 dose titration study of BAT1306 and BAT8001 2.4mg/kg , then choose a proper dose for amplification study based on DLT result
BIOLOGICAL	BAT1306 and BAT8001 3.6mg/kg	Phase 1 dose titration study of BAT1306 and BAT8001 3.6mg/kg , then choose a proper dose for amplification study based on DLT result

Timeline

• Start date: 2019-06-21
• Primary completion: 2020-12-31
• Completion: 2021-06-30
• First posted: 2019-11-05
• Last updated: 2019-11-05

Locations

1 site across 1 country: China