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

Primary Purpose

Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
AK112
Sponsored by
Akeso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Pulmonary HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AK112

Arm Description

Subjects receive AK112 monotherapy intravenously (IV) until no more benefits from treatment.

Outcomes

Primary Outcome Measures

Objective response rates (ORR)
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.
Number of participants with adverse events (AEs)
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.
Progression-free survival (PFS)
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).

Secondary Outcome Measures

Disease control rate (DCR)
Disease control rate (DCR) assessed according to RECIST v1.1
Duration of response (DOR)
Duration of response (DOR) assessed according to RECIST v1.1
Overall survival (OS)
Overall survival is defined as the time from the start of treatment with AK112 until death due to any cause.
Maximum observed concentration (Cmax) of AK112
Serum concentrations of AK112 in individual subjects at different time points after AK112 administration
Anti-drug antibodies (ADA)
Number of subjects with detectable anti-drug antibodies (ADA)
PD-L1 expression
The correlationship between PD-L1 expression and AK112 anti-tumor activity

Full Information

First Posted
April 29, 2021
Last Updated
October 8, 2022
Sponsor
Akeso
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1. Study Identification

Unique Protocol Identification Number
NCT04900363
Brief Title
A Trial of AK112 (PD-1/VEGF Bispecific Antibody) in Patients With NSCLC
Official Title
A Phase Ib/II Trial of AK112 (PD-1/VEGF Bispecific Antibody) in Patients With Advanced NSCLC
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akeso

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AK112
Arm Type
Experimental
Arm Description
Subjects receive AK112 monotherapy intravenously (IV) until no more benefits from treatment.
Intervention Type
Drug
Intervention Name(s)
AK112
Intervention Description
Subjects receive AK112 intravenously.
Primary Outcome Measure Information:
Title
Objective response rates (ORR)
Description
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.
Time Frame
Up to approximately 2 years
Title
Number of participants with adverse events (AEs)
Description
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.
Time Frame
Up to approximately 2 years
Title
Progression-free survival (PFS)
Description
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).
Time Frame
Up to approximately 2 years
Secondary Outcome Measure Information:
Title
Disease control rate (DCR)
Description
Disease control rate (DCR) assessed according to RECIST v1.1
Time Frame
up to 2 years
Title
Duration of response (DOR)
Description
Duration of response (DOR) assessed according to RECIST v1.1
Time Frame
up to 2 years
Title
Overall survival (OS)
Description
Overall survival is defined as the time from the start of treatment with AK112 until death due to any cause.
Time Frame
up to 2 years
Title
Maximum observed concentration (Cmax) of AK112
Description
Serum concentrations of AK112 in individual subjects at different time points after AK112 administration
Time Frame
Up to 2 years
Title
Anti-drug antibodies (ADA)
Description
Number of subjects with detectable anti-drug antibodies (ADA)
Time Frame
Up to 2 years
Title
PD-L1 expression
Description
The correlationship between PD-L1 expression and AK112 anti-tumor activity
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weifeng Song, MD
Phone
+86(0760)89873999
Email
clinicaltrials@akesobio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caicun Zhou, MD
Organizational Affiliation
Shanghai Pulmonary Hospital, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caicun Zhou, MD
Phone
+86-021-65115006
Email
caicunzhoudr@163.com
First Name & Middle Initial & Last Name & Degree
Caicun Zhou, MD

12. IPD Sharing Statement

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

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