Status:
UNKNOWN
A Study to Evaluate the Efficacy and Safety of AK127 in Patients With Advanced Solid Tumors
Lead Sponsor:
Akeso
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study is to characterize the safety, tolerability and anti-tumor activity of AK127 as a single agent in adult subjects with advanced solid tumor malignancies.
Detailed Description
This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK127 as a single agent in adult subjects with advanced ...
Eligibility Criteria
Inclusion
- Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.
- Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- Life expectancy ≥3 months.
- Histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject is not suitable for standard therapy.
- Adequate organ function.
- Patients of childbearing potential must agree to use effective contraceptive measures.
Exclusion
- The patient has received prior immunotherapy against TIGIT target.
- Not currently enrolled in any other clinical study.
- Receipt of any anticancer therapy within 4 weeks or within 5 half-lives of the drug prior to the first dose of AK127.
- Symptomatic central nervous system metastases.
- Active malignancies within the past 1 years, with the exception of tumors in this study and cured local tumors.
- Active autoimmune disease requiring systemic treatment prior to the start of study treatment.
- There is a history of major diseases 1 year prior to the first dose.
- Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose.
- Received chest radiation therapy prior to the first dose.
- Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
- Active or previously documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).
- Receipt of live or attenuated vaccination within 4 weeks prior to the first dose of AK127.
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Known history of active tuberculosis.
- History of organ transplant or hematopoietic stem cell.
- History of primary immunodeficiency.
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
- Other cases deemed inappropriate by the investigator.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05393063
Start Date
June 1 2022
End Date
June 1 2024
Last Update
May 26 2022
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