- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04900363
A Trial of AK112 (PD-1/VEGF Bispecific Antibody) in Patients With NSCLC
October 8, 2022 updated by: Akeso
A Phase Ib/II Trial of AK112 (PD-1/VEGF Bispecific Antibody) in Patients With Advanced NSCLC
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%.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
108
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200433
- Recruiting
- Shanghai Pulmonary Hospital
-
Contact:
- Caicun Zhou, MD
- Phone Number: +86-021-65115006
- Email: caicunzhoudr@163.com
-
Principal Investigator:
- Caicun Zhou, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Has a histologically or cytologically confirmed diagnosis of NSCLC.
- Has StageIIIB/C or IV NSCLC (American Joint Committee on Cancer [AJCC]).
- 18 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AK112
Subjects receive AK112 monotherapy intravenously (IV) until no more benefits from treatment.
|
Subjects receive AK112 intravenously.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rates (ORR)
Time Frame: Up to approximately 2 years
|
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.
|
Up to approximately 2 years
|
Number of participants with adverse events (AEs)
Time Frame: Up to approximately 2 years
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
|
Up to approximately 2 years
|
Progression-free survival (PFS)
Time Frame: Up to approximately 2 years
|
PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).
|
Up to approximately 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control rate (DCR)
Time Frame: up to 2 years
|
Disease control rate (DCR) assessed according to RECIST v1.1
|
up to 2 years
|
Duration of response (DOR)
Time Frame: up to 2 years
|
Duration of response (DOR) assessed according to RECIST v1.1
|
up to 2 years
|
Overall survival (OS)
Time Frame: up to 2 years
|
Overall survival is defined as the time from the start of treatment with AK112 until death due to any cause.
|
up to 2 years
|
Maximum observed concentration (Cmax) of AK112
Time Frame: Up to 2 years
|
Serum concentrations of AK112 in individual subjects at different time points after AK112 administration
|
Up to 2 years
|
Anti-drug antibodies (ADA)
Time Frame: Up to 2 years
|
Number of subjects with detectable anti-drug antibodies (ADA)
|
Up to 2 years
|
PD-L1 expression
Time Frame: Up to 2 years
|
The correlationship between PD-L1 expression and AK112 anti-tumor activity
|
Up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 21, 2021
Primary Completion (Anticipated)
May 1, 2023
Study Completion (Anticipated)
May 1, 2024
Study Registration Dates
First Submitted
April 29, 2021
First Submitted That Met QC Criteria
May 23, 2021
First Posted (Actual)
May 25, 2021
Study Record Updates
Last Update Posted (Actual)
October 12, 2022
Last Update Submitted That Met QC Criteria
October 8, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AK112-202
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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