- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04172454
Safety and Efficacy of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Selected Advanced Solid Tumors
October 8, 2022 updated by: Akeso
A Multicenter, Open-label,Phase 1b/2 Study for Safety and Efficacy of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Selected Advanced Solid Tumors
A multicenter, open-label, phase 1b/2 study to evaluate the safety and efficacy of AK104, a PD-1 and CTLA-4 bispecific antibody, in selected advanced solid tumors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
68
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
-
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Guangdong
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Guangzhou, Guangdong, China, 510030
- Sun Yat-Sen University Cancer Center
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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.
- Male or female, age ≥ 18 years and ≤75, at the time of study entry.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
- Estimated life expectancy of ≥3 months.
- Histologically or cytologically documented advanced or metastatic melanoma and other selected advanced solid tumors.
- Subjects must have at least one measurable lesion per RECIST v1.1.
- Available archived tumor tissue sample to allow for correlative biomarker studies. In the setting where archival material is unavailable or unsuitable for use , the subject must consent and undergo fresh tumor biopsy (biopsy at acceptable risk as judged by the investigator).
- Adequate organ functions.
- Female subjects of childbearing potential who are sexually active with a nonsterilized male partner must use an acceptable method of contraception from screening, and must agree to continue using such precautions for 90 days after the final dose of investigational product.
- Subjects who agree to take effective contraception methods from screening to 120 days after the last dose of investigational product.
- Willing to follow all the experimental requirements designated by the protocol.
Exclusion Criteria:
- Prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment.
- Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies.
- Prior exposure to anti-tumor therapies, including systematic chemotherapy, radiotherapy, immunotherapy, hormone therapy, targeted therapy (within 2 weeks before the first administration of the study treatment), and systematic immune-modulators (including but not limited to interferon, interleukin-2 and tumor necrosis factor) within 4 weeks prior to the first administration of the study treatment. Prior exposure to Chinese herbal medicine or proprietary Chinese medicine with anti-tumor functions within 2 weeks prior to the first administration of the study treatment.
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria. Hair loss is excluded.
- For subjects previously treated with anti-PD-1, PD-L1 or other immunotherapies: (1) Subjects have experienced a toxicity that led to permanent discontinuation of prior immunotherapy. (2) All AEs while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening for this study. (3) Subjects have required the use of additional immunosuppression other than corticosteroids for the management of an AE, or have experienced recurrence of an AE if re-challenged with corticosteroids while receiving prior immunotherapy.
- Subjects with active, known or suspected autoimmune disease, or a medical history of autoimmune disease, with some exceptions.
- Active or previously documented inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis or chronic diarrhea).
- Prior use of systematic corticosteroid (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to the first administration of the study treatment.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Prior exposure to major surgery within 28 days prior to the first administration of the study treatment. Local procedures (eg, placement of a systemic port, core needle biopsy, and prostate biopsy) are allowed if completed at least 24 hours prior to the administration of the first dose of study treatment.
- Known history of interstitial lung disease. The subjects highly suspected of interstitial lung disease will be excluded. Subjects with severe lung diseases affecting lung functions will be excluded.
- Known history of active tuberculosis (TB). Subjects suspected of having active TB will be examined with x-ray, sputum, and clinical symptoms.
- Known history of primary immunodeficiency virus infection or known history of testing positive for human immunodeficiency virus (HIV).
- Subjects with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 1000 IU/ mL or active hepatitis C virus (HCV) should be excluded. Subjects with positive HCV antibodies are eligible only if the HCV RNA test results are negative.
- Serious infections within 4 weeks prior to the first dose of study drug.
- Receipt of live, attenuated vaccination within 30 days prior to the first dose of study treatment, or plan to receive live, attenuated vaccine during the study.
- Known history of sever hypersensitivity reaction to other monoclonal antibodies.
- Known history of allergy or hypersensitivity to AK104 or any of its components
- Any conditions that, in the investigator's opinion, may put subjects treated with the study drug at risks, or interfere with the evaluation of study drug or subject safety, or the interpretation of results.
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: AK104
AK104 in subjects with advanced melanoma and other selected advanced solid tumor including PD-1/PD-L1 relapsed/refractory tumors)
|
AK104, 6mg/kg, Q2W
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-tumor activity of AK104 using objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator
Time Frame: Up to 2 years
|
The ORR is defined as the proportion of subjects with confirmed CR or confirmed 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.
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Up to 2 years
|
Disease control rate (DCR)
Time Frame: Up to 2 years
|
The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.
|
Up to 2 years
|
Progression-free survival (PFS)
Time Frame: Up to 2 years
|
Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.
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Up to 2 years
|
Overall survival (OS)
Time Frame: Up to 2 years
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Overall survival is defined as the time from the start of treatment with AK104 until death due to any cause.
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Up to 2 years
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Number of subjects experiencing adverse events (AEs)
Time Frame: From the time of informed consent through 90 days after last dose of AK104
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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.
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From the time of informed consent through 90 days after last dose of AK104
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Minimum observed concentration (Cmin) of AK104 at steady state
Time Frame: From first dose of AK104 through to 90 days after last dose of AK104
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The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration.
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From first dose of AK104 through to 90 days after last dose of AK104
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Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time Frame: From first dose of AK104 through to 90 days after last dose of AK104
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The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
|
From first dose of AK104 through to 90 days after last dose of AK104
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Xiaoshi Zhang, MD, Sun Yat-sen University
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)
December 20, 2019
Primary Completion (Actual)
June 17, 2021
Study Completion (Actual)
September 23, 2022
Study Registration Dates
First Submitted
November 19, 2019
First Submitted That Met QC Criteria
November 19, 2019
First Posted (Actual)
November 21, 2019
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
- AK104-202
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.
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