- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04900350
A Trial of AK117 (Anti-CD47) in Patients With Myelodysplastic Syndrome
October 8, 2022 updated by: Akeso
A Phase I/II Trial of AK117 (Anti-CD47) in Patients With Higher-risk Myelodysplastic Syndrome
This is a open label, phase I/II study.
All patients are diagnosed with higher-risk MDS, Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
The purpose of this study is to evaluate the safety and efficacy of AK117 + azacitidine in subjects with higher-risk MDS.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
190
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
-
-
Jiangsu
-
Suzhou, Jiangsu, China, 215006
- Recruiting
- The First Affiliated Hospital of Soochow University
-
Contact:
- Depei Wu, MD
- Phone Number: +86-0512-65223637
- Email: drwudepei@163.com
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥18 years (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).
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
- Has a life expectancy of at least 12 weeks.
- Phase 1: Diagnosis of higher-risk MDS that is either previously untreated or relapsed/refractory.
- Phase 2: Diagnosis of higher-risk MDS that is previously untreated.
- White blood cell count ≤ 25 x 10^9/L (hydroxyurea may be used to reduce the WBC count).
- Has adequate organ function.
- 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 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.
- Previous allogeneic hematopoietic stem cell transplant (allo-HSCT) .
- Prior treatment with any anti-CD47 or anti-SIRPα (signal regulatory protein alpha) agent.
- 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 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: AK117+ azacitidine
Phase 1: Subjects will receive escalating doses of A117 in combination with azacitidine 75 mg/m2 subcutaneous daily for 7 days of a 28 day cycle; Phase 2: Subjects will receive AK117 at the recommended Phase 2 dose in combination with azacitidine 75 mg/m2 subcutaneous daily for 7 days of a 28-day cycle. |
Subjects receive AK117 intravenously.
Subjects receive Azacitidine subcutaneously.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Complete Remission (CR)
Time Frame: Approximately 6 months
|
Number of participants achieving a CR per International Working Group (IWG) 2006 criteria.
|
Approximately 6 months
|
Number of participants with adverse events (AEs)
Time Frame: Up to approximately 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 approximately 2 years.
|
Duration of Complete Remission (DoCR)
Time Frame: Up to approximately 2 years.
|
The DoCR is measured from the time measurement criteria are first met for CR to the first date of relapse or death, whichever occurs earlier.
|
Up to approximately 2 years.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: Up to approximately 2 years.
|
ORR is defined as the proportion of participants who reach objective response including CR, Partial Remission (PR), marrow CR, or hematologic improvement per IWG 2006 MDS criteria prior to initiation of any new MDS therapy.
|
Up to approximately 2 years.
|
Duration of Response (DOR)
Time Frame: Up to approximately 2 years.
|
DOR is measured from the time measurement criteria are first met for objective response to the first date of relapse or death, whichever occurs earlier.
|
Up to approximately 2 years.
|
Progression Free Survival (PFS)
Time Frame: Up to approximately 2 years.
|
PFS is defined as the time from the start of treatment with AK117 until the first documentation of disease progression or death due to any cause, whichever occurs first.
|
Up to approximately 2 years.
|
Maximum observed concentration (Cmax) of AK117
Time Frame: Up to 2 years.
|
Serum concentrations of AK117 in individual subjects at different time points after AK117 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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Depei Wu, MD, The First Affiliated Hospital of Soochow 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)
June 18, 2021
Primary Completion (Anticipated)
May 1, 2023
Study Completion (Anticipated)
May 1, 2024
Study Registration Dates
First Submitted
May 19, 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
- AK117-103
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 Myelodysplastic Syndrome
-
Brian JonasNational Cancer Institute (NCI); Celgene; Pharmacyclics LLC.CompletedPreviously Treated Myelodysplastic Syndrome | Myelodysplastic Syndrome | Therapy-Related Myelodysplastic Syndrome | Secondary Myelodysplastic Syndrome | Refractory High Risk Myelodysplastic SyndromeUnited States
-
Thomas Jefferson UniversityAbbVieRecruitingMyelodysplastic Syndrome | Recurrent Myelodysplastic Syndrome | Refractory Myelodysplastic SyndromeUnited States
-
Uma BorateRecruitingTherapy-Related Myelodysplastic Syndrome | Secondary Myelodysplastic SyndromeUnited States
-
University Hospital, BrestRecruitingMyelodysplastic Syndromes | Myelodysplastic Syndrome With Isolated Del(5Q) | Myelodysplastic Syndrome With Del(5Q)France
-
Cyclacel Pharmaceuticals, Inc.SuspendedLeukemia | Myelodysplastic Syndrome(MDS)United States
-
TJ Biopharma Co., Ltd.Recruiting
-
National Heart, Lung, and Blood Institute (NHLBI)National Cancer Institute (NCI)RecruitingMyelodysplastic Syndromes (MDS)United States, Israel
-
AbbVieCelgene; Genentech, Inc.CompletedMyelodysplastic Syndromes (MDS)United States, Australia, Germany
-
AbbVieGenentech, Inc.Active, not recruitingMyelodysplastic Syndromes (MDS)United States, Australia, Canada, France, Germany, Italy, United Kingdom
-
The First Affiliated Hospital with Nanjing Medical...UnknownMyelodysplastic Syndromes (MDS)China
Clinical Trials on AK117
-
Akesobio Australia Pty LtdCompleted
-
AkesoRecruitingAcute Myeloid LeukemiaChina
-
AkesoRecruitingHigher-risk Myelodysplastic SyndromesUnited States, China
-
Craig L Slingluff, JrTerminated
-
AkesoRecruitingMetastatic Triple-negative Breast Cancer | Locally Advanced Triple-negative Breast CancerChina
-
AkesoRecruitingAdvanced Malignant TumorsChina
-
AkesoRecruitingResectable Gastric or Gastroesophageal Junction AdenocarcinomaChina
-
AkesoRecruitingAdvanced Malignant TumorsChina