Actively Recruiting

Phase 2
Age: 18Months - 75Months
All Genders
NCT06875076

Multicenter Single-Arm Study of Ivonescimab (AK112) Combined with Chemotherapy in Pretreated Pleural Mesothelioma

Led by The First Hospital of Jilin University · Updated on 2025-03-13

25

Participants Needed

1

Research Sites

247 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is a prospective, multicenter, single-arm, Phase II clinical trial evaluating the efficacy and safety of ivonescimab (AK112) combined with chemotherapy in patients with pleural mesothelioma who failed prior immunotherapy, anti-angiogenic therapy, or chemotherapy. The regimen consists of a treatment phase (ivonescimab 20mg/kg combined with pemetrexed 500mg/m²/gemcitabine 1000mg/m²/vinorelbine 25mg/m² every 21 days for 4 cycles) followed by a maintenance phase (ivonescimab monotherapy 20mg/kg every 21 days until disease progression, intolerance, or up to 2 years).The trial plans to enroll 25 patients, with the primary endpoint being objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), overall survival (OS), and safety profiles. Exploratory endpoints investigate biomarkers such as tertiary lymphoid structures, tumor-infiltrating lymphocytes, and macrophage polarization within the tumor microenvironment.

CONDITIONS

Official Title

Multicenter Single-Arm Study of Ivonescimab (AK112) Combined with Chemotherapy in Pretreated Pleural Mesothelioma

Who Can Participate

Age: 18Months - 75Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Asian ethnicity, aged 18 to 75 years, with ECOG performance status 0 or 1
  • Histologically confirmed malignant pleural mesothelioma
  • Disease progression after 1 to 2 prior systemic therapies including platinum-based chemotherapy, immunotherapy combinations, or anti-angiogenic therapy
  • At least one measurable lesion according to modified RECIST 1.1 criteria
  • Adequate organ function with hemoglobin 90 g/L, neutrophils 1.5 x 10^9/L, and creatinine clearance 50 ml/min
Not Eligible

You will not qualify if you...

  • History of other malignancies within 5 years except cured skin carcinoma or carcinoma in situ with radical resection
  • Tumor encasing major blood vessels, necrosis, or cavitation posing significant bleeding risk
  • Tumor invasion of adjacent critical organs or risk of fistula formation
  • Current participation in other interventional clinical trials or recent investigational drug/device use within 4 weeks
  • Recent palliative local therapy or immunomodulatory treatments within 1 to 2 weeks
  • Prior systemic anti-angiogenic therapy combined with PD-1/PD-L1 inhibitors
  • Bleeding history Grade 3 within 4 weeks or history of organ transplantation
  • Active uncontrolled infections or recent acute exacerbations of lung diseases
  • Idiopathic pulmonary fibrosis, organizing pneumonia, or drug-induced pneumonitis
  • Major surgery or severe trauma within 30 days, or planned major surgery within 30 days after first dose
  • History of serious heart conditions or recent cardiovascular events within 12 months
  • Uncontrolled hypertension or hypertensive crisis
  • Active central nervous system metastases except asymptomatic brain metastases
  • Active gastrointestinal bleeding or high risk of perforation
  • Active autoimmune diseases needing systemic treatment within 2 years
  • Chronic corticosteroid use over 10 mg/day prednisone equivalent
  • Non-healing wounds or fractures
  • Known hypersensitivity to study drugs or monoclonal antibodies
  • Reproductive criteria requiring contraception during and 6 months post-treatment
  • Positive HIV infection
  • Untreated active hepatitis B or active hepatitis C infection
  • Substance abuse or psychiatric disorders affecting compliance
  • Live vaccination within 30 days prior to first dose
  • Other conditions interfering with study participation or results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Cancer center, First Hospital of Jilin University

Changchun, Jilin, China, 130000

Actively Recruiting

Loading map...

Research Team

K

Kewei Ma

CONTACT

M

Ma, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here