NCT06750952

Ivonescimab Combined with Chemotherapy As First-line Treatment of Relapsed or Metastatic Thymic Cancer: a Prospective, Single Arm, Phase II Trial

Ivonescimab Combined with Chemotherapy As First-line Treatment of Relapsed or Metastatic Thymic Cancer: a Prospective, Single Arm, Phase II Trial (iTHYM)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single arm phase II clinical trial ,aimed at exploring the efficacy and safety of the combination therapy of anti-PD-1 and VEGF bispecific antibody Ivonescimab combined with chemotherapy as first-line treatment of relapsed or metastatic thymic cancer.

Detailed description

This study is a prospective, single arm phase II clinical trial ,aimed at exploring the efficacy and safety of the combination therapy of anti-PD-1 and VEGF bispecific antibody Ivonescimab combined with chemotherapy as first-line treatment of relapsed or metastatic thymic cancer. Patients who met the inclusion criteria and were pathologically confirmed to be metastatic or recurrent thymic cancer were treated with first-line treatment of Ivonescimab (20mg/kg) combined with chemotherapy (carboplatin and paclitaxel / albumin paclitaxel), and the efficacy was evaluated clinically and radiologically. The primary endpoint of this study was the 6-month progression free survival rate (PFS6m), and the secondary endpoints included PFS, objective response rate (ORR), disease control rate (DCR), duration of remission (DOR), and overall survival (OS), as well as safety related research indicators including adverse events (AE) and quality of life score (QOL). During the study, biological samples were collected from patients, and exploratory studies on the efficacy and side effect biological markers of Ivonescimab were carried out.

Conditions

• Relapsed or Metastatic Thymic Cancer
• First-line Treatment

Interventions

Type	Name	Description
DRUG	Ivonescimab Combined With Chemotherapy	Ivonescimab injection is an IgG1 subtype humanized bispecific antibody targeting human vascular endothelial growth factor-A (VEGF-A) and programmed death protein-1 (PD-1). It can bind to VEGF-A and PD-1 at the same time, and competitively block the interaction between VEGF-A, PD-1 and their ligands, exerting antitumor activity.

Timeline

• Start date: 2024-12-20
• Primary completion: 2026-12-20
• Completion: 2028-12-20
• First posted: 2024-12-27
• Last updated: 2024-12-27