A Phase Ib/II Trial of AK112 (PD-1/VEGF Bispecific Antibody) in Patients With Advanced NSCLC

  • STATUS
    Recruiting
  • End date
    May 22, 2024
  • participants needed
    108
  • sponsor
    Akeso
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Updated on 22 October 2022
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measurable disease

Summary

This trial is a Phase Ib/II study. All patients are stage IIIB/C or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 in subjects with advanced NSCLC whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.

Details
Condition Non-small Cell Lung Cancer
Treatment AK112
Clinical Study IdentifierNCT04900363
SponsorAkeso
Last Modified on22 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Has a histologically or cytologically confirmed diagnosis of NSCLC
Has StageIIIB/C or IV NSCLC (American Joint Committee on Cancer [AJCC])
to 75 years old (at the time consent is obtained)
Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures)
Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy
Has a life expectancy of at least 3 months
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team
Has adequate organ function
Has recovered from the effects of any prior radiotherapy or surgery
All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment

Exclusion Criteria

Is currently participating in a study of an investigational agent or using an investigational device
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within 2 years prior to the first dose of study treatment
Has undergone major surgery within 30 days of Study Day 1
Has a known additional malignancy that is progressing or requires systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
Has known active central nervous system (CNS) metastases
Has carcinomatous meningitis
Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Has an active infection requiring systemic therapy
Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)
History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Has received a live virus vaccine within 30 days of the planned first dose of study therapy
Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment
Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject
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