NCT06838546

A Multicenter, Open Phase IIb Clinical Study to Evaluate the Efficacy and Safety of B1962 Injection in the Treatment of Advanced Colorectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Tasly Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, open-label, two-stage Phase IIb clinical study to evaluate the efficacy and safety of B1962 in the treatment of advanced colorectal cancer. The subjects were patients with distant metastasis or unresectable locally advanced colorectal cancer who had previously failed oxaliplatin, irinotecan, fluorouracil-based drugs therapy containing disease progression or intolerable toxic side effects. Two dose groups were investigated: Dose group 1: B1962 35 mg/kg, intravenous infusion, Q2W, Dose group 2: B1962 45 mg/kg, intravenous infusion, Q2W.

Conditions

• Advanced Colorectal Cancer

Interventions

Type	Name	Description
DRUG	B1962	B1962 has higher VEGF anti angiogenic activity than its competitors. Phase I clinical trials have shown that B1962 has excellent safety and promising therapeutic effects. Large scale clinical studies may achieve better therapeutic effects than similar competitors targeting the same target

Timeline

• Start date: 2025-02-24
• Primary completion: 2027-01-01
• Completion: 2027-01-31
• First posted: 2025-02-20
• Last updated: 2025-02-20

Locations

1 site across 1 country: China