- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04982276
A Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
October 17, 2022 updated by: Akeso
An Open Label, Multicentre, Phase Ib/II Clinical Study of AK109 and AK104 With or Without Chemotherapy in Second-line Treatment of Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
This is an open label, multicentre, Phase Ib/II Clinical Study of AK109 and AK104 With or Without Chemotherapy in Second-line Treatment of Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma .
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
87
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
-
-
-
Beijing, China
- Recruiting
- Beijing Cancer Hospital
-
-
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:
- Written and signed informed consent
- Age ≥ 18 years but ≤ 75 years
- ECOG of 0 or 1.
- Estimated life expectancy of ≥3 months.
- Histologically or cytologically documented advanced unresectable or metastatic gastric adenocarcinoma or gastroesophageal Junction (GEJ) adenocarcinoma.
- At least one measurable lesion per RECIST v1.1.
- Gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma with failure of first-line treatment
- Adequate organ function.
- Have agreed to take effective contraception from the date of signing the informed consent form until 120 days after the last administration.
Exclusion Criteria:
- Known HER2-positive
- Other invasive malignancies within 3 years, except for locally treatable (manifested as cured) malignancies, such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ.
- Any previous systemic therapy targeting VEGF or anti-VEGFR signaling pathways.
- In addition to PD1 or PD-L1,Prior exposure to anti-CTLA-4 antibody, or any other antibody or drug therapy for T cell co-stimulatory or checkpoint pathways, such as ICOS or agonists (e.g. CD40, CD137, GITR and OX40 etc).
- Known history of primary immunodeficiency virus infection.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Known history of interstitial lung disease.
- Known history of active tuberculosis (TB).
- Central nervous system (CNS) metastasis, meningeal metastasis, spinal cord compression, or leptomeningeal disease.
- Patients with untreated chronic hepatitis B or HBV DNA exceeding 500IU/mL or active hepatitis C should be excluded. Patients with HCV antibody positive are eligible to participate in the study if the results of HCV RNA test show negative.
- Known history of testing positive for human immunodeficiency virus (HIV).
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Subjects with active, known or suspected autoimmune disease, or a medical history of autoimmune disease, with the exceptions of the following: vitiligo, alopecia, Grave disease, psoriasis or eczema not requiring systemic treatment within the last 2 years, hypothyroidism (caused by autoimmune thyroiditis) only requiring steady doses of hormone replacement therapy and type I diabetes only requiring steady doses of insulin replacement therapy, or completely relieved childhood asthma that requires no intervention in adulthood, or primary diseases that will not relapse unless triggered by external factors.
- Pregnant or lactating women.
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: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: AK104 and AK109
AK104 IV every 2 weeks (q4w) AK109 IV every 2 weeks (q4w)
|
Subjects will receive AK104 and AK109 by intravenous administration.
|
EXPERIMENTAL: AK104 and AK109 combined with chemotherapy
AK104 IV every 2 weeks (q4w) AK109 IV every 2 weeks (q4w) PTX iV 85mg/m2 day1 day8 day15(q4w)
|
Subjects will receive AK104 and AK109 by intravenous administration.
Subjects will receive AK104 and AK109 in combination with PTX.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects experiencing dose-limiting toxicities (DLTs)
Time Frame: During the first 4 weeks
|
DLTs will be assessed during the first 28 days of treatment and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications .
|
During the first 4 weeks
|
Adverse events (AEs)
Time Frame: up to 2 years
|
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
|
up to 2 years
|
Objective response rate (ORR)
Time Frame: up to 2 years
|
The ORR is defined as the proportion of subjects with CR or PR, based on RECIST Version 1.1.
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of response (DoR)
Time Frame: Up to 2 years
|
Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
|
Up to 2 years
|
Progression-free survival (PFS)
Time Frame: Up to 2 years
|
PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1) or death from any cause (whichever occurs first)
|
Up to 2 years
|
Disease control rate (DCR)
Time Frame: Up to 2 years
|
DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1
|
Up to 2 years
|
Overall survival (OS)
Time Frame: up to 2 years
|
OS defined as the time from the first dose to death from any cause.
Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
|
up to 2 years
|
Observed pharmacokinetics (PK) exposure of AK109 and AK104
Time Frame: From first dose of AK109 and AK104 through 90 days after last dose of AK109 and AK104
|
The endpoints for assessment of PK of AK109 and AK104 include serum concentrations of AK109 and AK104 at different timepoints after AK109 and AK104 administration.
|
From first dose of AK109 and AK104 through 90 days after last dose of AK109 and AK104
|
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time Frame: From first dose of AK109 and AK104 through 90 days after last dose of AK109 and AK104
|
The immunogenicity of AK104 and AK109 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs)
|
From first dose of AK109 and AK104 through 90 days after last dose of AK109 and AK104
|
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)
July 13, 2021
Primary Completion (ANTICIPATED)
July 30, 2023
Study Completion (ANTICIPATED)
January 30, 2024
Study Registration Dates
First Submitted
July 21, 2021
First Submitted That Met QC Criteria
July 21, 2021
First Posted (ACTUAL)
July 29, 2021
Study Record Updates
Last Update Posted (ACTUAL)
October 19, 2022
Last Update Submitted That Met QC Criteria
October 17, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AK109-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma
-
M.D. Anderson Cancer CenterRecruitingClinical Stage III Gastric Cancer AJCC v8 | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction... and other conditionsUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)RecruitingClinical Stage III Gastric Cancer AJCC v8 | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedClinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction Adenocarcinoma | Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Postneoadjuvant... and other conditionsUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)RecruitingClinical Stage III Gastric Cancer AJCC v8 | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction... and other conditionsUnited States, Puerto Rico
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingGastric Adenocarcinoma | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage 0 Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage IIB Gastric Cancer AJCC v8 | Clinical Stage IVA Gastric Cancer AJCC v8 | Pathologic Stage 0 Gastric... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingPeritoneal Carcinomatosis | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction Adenocarcinoma | Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma... and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingClinical Stage III Gastric Cancer AJCC v8 | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction... and other conditionsUnited States
-
Ohio State University Comprehensive Cancer CenterNot yet recruitingGastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage II Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IIB Gastric... and other conditionsUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI); IpsenWithdrawnGastric Adenocarcinoma | Metastatic Gastroesophageal Junction Adenocarcinoma | Unresectable Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | Locally Advanced Unresectable Gastric Adenocarcinoma | Metastatic Unresectable Gastric AdenocarcinomaUnited States
-
Astellas Pharma Global Development, Inc.AvailableMetastatic Gastroesophageal Junction (GEJ) Adenocarcinoma | Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer | Locally Advanced Unresectable Gastric Adenocarcinoma Cancer | Metastatic Gastric Adenocarcinoma CancerUnited States, Germany
Clinical Trials on AK104 and AK109
-
AkesoRecruitingAdvanced Solid TumorChina
-
AkesoNot yet recruitingGastric and Gastroesophageal Junction Adenocarcinoma
-
AkesoCompleted
-
AkesoNot yet recruiting
-
Second Affiliated Hospital of Zunyi Medical UniversityGuizhou Provincial People's Hospital; The First People's Hospital of Zunyi; Guizhou... and other collaboratorsRecruitingImmunotherapy | Second-line TreatmentChina
-
Wuhan Union Hospital, ChinaRecruiting
-
AkesoNot yet recruitingHepatocellular CarcinomaChina
-
AkesoActive, not recruitingAdvanced or Metastatic Solid TumorsAustralia