NCT05148325

Assessment of Safety ,Tolerance and Pharmacokinetics Clinical Efficacy With BAT4706 in Advanced Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetics of BAT4706 Injection in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetics of BAT4706 Injection in Patients With Advanced Solid Tumors.

Detailed description

This study is a single center, open, dose increasing and dose expanding phase I clinical study. The dose increasing method of "3 + 3" is used to explore the safety, tolerance and PK characteristics of BAT4706 injection in patients with advanced solid tumors. After the completion of dose increment, 1-2 tolerated doses were selected for extended research on melanoma (20-40 cases), so as to provide recommended doses for subsequent clinical trials.

Conditions

• Advanced Solid Tumor
• Melanoma

Interventions

Type	Name	Description
DRUG	BAT4706	The administration cycle was proposed to be 3 weeks (Q3W), i.e., 21 days in a cycle, and the first 4 cycles were administered on the first day of each cycle.

Timeline

• Start date: 2021-09-02
• Primary completion: 2024-11-05
• Completion: 2024-11-05
• First posted: 2021-12-08
• Last updated: 2026-04-01

Locations

1 site across 1 country: China