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Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT05689853
Recruitment Status : Not yet recruiting
First Posted : January 19, 2023
Last Update Posted : January 19, 2023
Sponsor:
Information provided by (Responsible Party):
Akeso

Brief Summary:
This is a Phase Ib/II study to assess the safety, tolerability and preliminary efficacy of AK119 combined with AK112 in patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: AK119 Drug: AK112 Phase 1 Phase 2

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Study Type : Interventional
Estimated Enrollment : 87 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, Phase Ib/II Study to Evaluate the Safety, Tolerability and Antitumor Activity of AK119 in Combination With AK112 in Patients With Advanced Solid Tumors
Estimated Study Start Date : February 2023
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024

Arm Intervention/treatment
Experimental: AK119 in combination with AK112
AK119 and AK112, IV, every 3 weeks
Drug: AK119
AK119 is an anti-CD73 monoclonal antibody.

Drug: AK112
AK112 is a bispecific monoclonal antibody against VEGF and PD-1.




Primary Outcome Measures :
  1. Number of subjects with dose limiting toxicities (DLTs) [ Time Frame: During the first three weeks ]
    DLTs will be assessed during the first three weeks of treatment. DLTs 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 that occurs within the DLT observation period.

  2. Number of subjects with adverse events (AEs) [ Time Frame: From the time of informed consent signed through 90 days after the last dose of study drug. ]
    AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.

  3. Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]
    ORR is defined as the proportion of subjects with CR or PR (based on RECIST Version 1.1).


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: Up to 2 years ]
    PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1).

  2. 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 Version 1.1).

  3. 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 (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.

  4. Time to response (TTR) [ Time Frame: Up to 2 years ]
    Time to response (TTR) is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieved CR or PR (based on RECIST Version 1.1).

  5. Time to progression (TTP) [ Time Frame: Up to 2 years ]
    Time to progression (TTP) is defined as the time from the start of the treatment to the documentation of disease progression (based on RECIST Version 1.1).

  6. Overall survival (OS) [ Time Frame: Up to 2 years ]
    OS defined as the time from the first dose to death from any cause.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Voluntarily written informed consent and agree to comply with all protocol-specified procedures and follow-up evaluations
  2. Age ≥ 18 years and ≤ 75 years
  3. Histologically or cytologically-confirmed diagnosis of advanced/unresectable solid tumor that have been progressed or intolerant to at least one standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
  4. Measurable lesion based on RECIST v1.1
  5. ECOG status of 0 or 1
  6. Life expectancy ≥ 3 months
  7. Adequate organ function
  8. Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 120 days following the last dose of study treatment

Exclusion Criteria:

  1. Known other active malignancy within 3 years prior to the first dose of investigational product, with the exception of early stage cancers that have treated with curative intent
  2. Currently participating in another study unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study
  3. Received systemic antineoplastic therapy ( e.g. chemotherapy, radiotherapy, immunotherapy) within 4 weeks prior to the first dose of investigational product; received small-molecule anticancer agents within 2 weeks prior to the first dose of investigational product
  4. In addition to anti-PD-(L)1 monoclonal antibody, prior exposure to other immune checkpoint inhibitors or any other treatment directed to tumor immune mechanism
  5. Prior therapy targeting CD73 or CD39 or the adenosine signalling pathway
  6. Treatment with non-steroidal anti-inflammatory drugs, anti-platelet agents or anticoagulants within 7 days prior to the first dose of investigational product
  7. Current dependency on systemic therapy with glucocorticoids (>10 mg/day prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of investigational product
  8. Presence of spinal cord compression or active brain metastases
  9. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage
  10. History or presence of a serious hemorrhage or known bleeding tendency within 3 months
  11. Active autoimmune disease that has required systemic treatment in past 2 years
  12. Clinically significant cardiovascular disease
  13. History of interstitial lung disease or noninfectious pneumonitis
  14. Received systemic anti-infective therapy (excluding antiviral therapy for hepatitis B or C) within 14 days prior to the first dose of investigational product
  15. Major surgical procedure or serious trauma within 28 days prior to the first dose of investigational product
  16. History of immunodeficiency, human immunodeficiency virus infection (HIV)
  17. Active tuberculosis or syphilis infection
  18. History of organ transplantation or allogeneic haematopoietic stem cell transplantation
  19. Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0)
  20. Any other conditions that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study 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): NCT05689853


Contacts
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Contact: Ting Liu, MD +86(0760)8987 3999 clinicaltrials@akesobio.com

Sponsors and Collaborators
Akeso
Investigators
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Principal Investigator: Wenming Wu, PhD Peking Union Medical College Hospital
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Responsible Party: Akeso
ClinicalTrials.gov Identifier: NCT05689853    
Other Study ID Numbers: Ak119-105
First Posted: January 19, 2023    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: January 2023

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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