NCT06404905

Clinical Trial of BT02 in Patients With Advanced Solid Tumors

A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients with Advanced Solid Tumors

Detailed description

Overall study design: This is an open-label, FIH, Phase I / II study of BT02 to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of BT02 in adult patients with advanced solid tumors.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	BT02 monoclonal antibody injection	It is expected to include 10-30 patients assigned to dose escalation cohorts.

Timeline

• Start date: 2024-01-24
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-05-08
• Last updated: 2024-12-27

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study