NCT03897283

Study of TQB2450 Combined With Anlotinib in Patients With Advanced Solid Tumors

Phase Ib Study of TQB2450 Combined With Anlotinib in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1),which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. As a novel multitarget tyrosine kinase inhibitor for tumor angiogenesis and proliferative signaling，anlotinib is approved for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have undergone progression or recurrence after ≥ 2 lines of systemic chemotherapy. The Phase III study showed that the Overall Survival (OS), Progression-Free Survival (PFS) and Overall Response Rate (ORR) were significantly better than placebo group.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	TQB2450	TQB2450 1200 mg administered IV on Day 1 of each 21-day cycle
DRUG	Anlotinib	Anlotinib capsules given orally in fasting conditions, dose ranging from 8 mg to 12 mg once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21). Initial dose is 10 mg. If there are no patients with DLT in first treatment cycle , begin to explore dose of 12 mg. If there are 2 or more patients in 3 patients with DLT, 8 mg dose is to explore.

Timeline

• Start date: 2019-06-20
• Primary completion: 2020-06-30
• Completion: 2021-12-01
• First posted: 2019-04-01
• Last updated: 2019-10-30

Locations

1 site across 1 country: China