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

Sponsor
Sun Yat-sen University
Study ID
NCT06750952
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • First-line Treatment
  • Relapsed or Metastatic Thymic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ivonescimab Combined With Chemotherapy — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 20, 2024
Status verified
Dec 2024
Primary completion
Dec 20, 2026
Completion
Dec 20, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ivonescimab
    Ivonescimab combined with chemotherapy：Ivonescimab，20mg/kg， iv. drip, D1, Q3W；Paclitaxel, 175mg/m2 or albumin paclitaxel, 260mg/m2, iv. drip, D1, Q3W；Carboplatin, AUC5， iv.drip,D1, Q3W。After 4-6 cycles of combination therapy, Ivonescimab was maintained until PD or toxicity was intolerable.

Primary Outcome Measure

Progression free survival at 6 months（PFS 6m） [ Time Frame: Within one year after starting treatment. ]

Central Contacts