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A Study of AK104 in Subjects With Locally Advanced Unresectable or Metastatic MSI-H/dMMR Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04547101
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Collaborator:
Akeso Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Akeso

Brief Summary:
It is a single-arm, open-label, multicenter, phase II study to evaluate the safety, efficacy, pharmacokinetics (PK) and immunogenicity of AK104 as a single agent in subjects with previously-treated locally advanced unresectable or metastatic MSI-H or dMMR solid tumors.

Condition or disease Intervention/treatment Phase
MSI-H/dMMR Solid Tumor Drug: AK104 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Open-label, Multicenter, Phase II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Subjects With Locally Advanced Unresectable or Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors
Actual Study Start Date : April 24, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AK104 Drug: AK104
AK104,6 mg/kg IV,every 2 weeks (Q2W)




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Up to 2 years ]
    ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.


Secondary Outcome Measures :
  1. Disease control rate (DCR) [ Time Frame: Up to 2 years ]
    DCR is defined as the proportion of subjects with confirmed CR, PR, or SD, based on RECIST v1.1

  2. Duration of response (DoR) [ Time Frame: Up to 2 years ]
    DoR 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.

  3. Progression-free survival (PFS) [ Time Frame: Up to 2 years ]
    PFS 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.

  4. Overall survival (OS) [ Time Frame: Up to 2 years ]
    OS is defined as the time from the start of treatment with AK104 until death due to any cause.

  5. Adverse events (AEs) [ Time Frame: From first dose of AK104 through to 90 days after last dose of AK104 ]
    Incidences of treatment-emergent adverse events (TEAEs) , treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0

  6. Observed pharmacokinetics (PK) exposure of AK104 [ Time Frame: From first dose of AK104 through to 90 days after last dose of AK104 ]
    The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration.

  7. 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 ]
    The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable ADAs.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have signed written informed consent form voluntarily.
  • Male or female, age ≥ 18 years on the day of signing informed consent form.
  • ECOG of 0 or 1.
  • Estimated life expectancy of ≥3 months.
  • Histologically or cytologically documented locally advanced unresectable or metastatic solid tumors.
  • Confirmed MSI-H/dMMR status by the central laboratory.
  • Have experienced documented disease progression during or after at least first-line therapy.
  • Have radiologically measurable disease based on RECIST 1.1.
  • 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:

  • Prior use of investigational products or devices within 4 weeks prior to C1D1 (Cycle 1 Day 1, the first dose of study drug).
  • Presence of active autoimmune disease that have received systematic treatment in the past 2 years; or that is judged to be possibly relapsed or requires planned treatment by investigators.
  • Active inflammatory bowel disease or that required treatment (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 C1D1.
  • Prior exposure to tumor immunotherapy, such as checkpoint inhibitors (eg. anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody), checkpoint agonists or cellular therapy.
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Known presence or history of interstitial lung disease.
  • History of gastrointestinal perforation and/or fistula within 6 months prior to C1D1.
  • Serious infections within 4 weeks prior to C1D1.
  • Known presence of active tuberculosis.
  • Known untreated chronic hepatitis B or chronic hepatitis B virus DNA exceeding 1000 IU/ mL or active hepatitis C virus.
  • Receipt of recent radiotherapy or anti-tumor treatment within 4 weeks prior to C1D1.
  • Presence of meningeal metastasis, spinal cord compression, leptomeningeal disease or central nervous system metastasis, with some exceptions.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04547101


Contacts
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Contact: Xiaoping Jin, PhD +86 (0760) 8987 3999 clinicaltrials@akesobio.com

Locations
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China, Guangdong
Sun Yat-Sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Ruihua Xu, M.D    +86 (020) 8734 3333    xurh@sysucc.org.cn   
Sponsors and Collaborators
Akeso
Akeso Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Ruihua Xu, MD Sun Yat-sen University
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Responsible Party: Akeso
ClinicalTrials.gov Identifier: NCT04547101    
Other Study ID Numbers: AK104-205
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms