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A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK127 in Combination With AK104 in Advanced and Metastatic Solid Tumours

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: NCT05021120
Recruitment Status : Recruiting
First Posted : August 25, 2021
Last Update Posted : January 9, 2023
Sponsor:
Information provided by (Responsible Party):
Akeso ( Akesobio Australia Pty Ltd )

Study Description
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Brief Summary:
A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK127 in combination with AK104.

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Solid Tumours Drug: AK127 Drug: AK104 Early Phase 1

Detailed Description:
This is a , Phase 1, first-in-human, multicenter, open label, dose escalation and dose expansion study designed to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK127 in combination with AK104 in subjects with advanced and metastatic solid tumours. The study comprises of 2 phases: a dose escalation phase and a dose expansion phase. Dose escalation for AK127 will occur using the 3+3+3 model given with a fixed regimen of AK104. Dose expansion will open at the discretion of the Sponsor.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 143 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Sequential Assignment
Masking: None (Open Label)
Masking Description: None (open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a/1b, Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumour Activity of AK127 in Combination With AK104 in Subjects With Advanced or Metastatic Solid Tumours
Actual Study Start Date : October 12, 2021
Estimated Primary Completion Date : January 10, 2025
Estimated Study Completion Date : April 7, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention/treatment
Experimental
 Drug: AK127
Subjects will receive AK127 by intravenous administration

Drug: AK104
After AK127 infusion, on the same day subjects will receive AK104 by intravenous administration


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and Nature of Adverse Events (AEs) [ Time Frame: From the time of informed consent signed through to 90 days after end of treatment ]
    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.

  2. Number of participants with a Dose Limiting Toxicity (DLT) [ Time Frame: Within the first six weeks of treatment ]
    DLTs will be assessed during the first treatment cycle and assessed as having a suspected relationship to study drug according to pre-specific criteria in the protocol.


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ 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.

  2. Disease control rate (DCR) [ Time Frame: Up to 2 years ]
    Progression-free survival is defined as the time from the start of treatment with AK127 + AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.

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

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

  5. Area under the curve (AUC) of AK127+AK104 for assessment of pharmacokinetics [ Time Frame: From first dose of treatment through to 90 days after end of treatment ]
    The endpoints for assessment of PK including serum concentrations of AK127+AK104 at different timepoints after treatment administration.

  6. Maximum observed concentration (Cmax) of AK127 + AK104 [ Time Frame: From first dose of treatment through to 90 days after end of treatment. ]
    The endpoints for assessment of PK of AK127+AK104 include serum concentrations of AK127+AK104 at different timepoints after treatment administration.

  7. Minimum observed concentration (Cmin) of AK127+AK104 [ Time Frame: From first dose of treatment through to 90 days after end of treatment ]
    The endpoints for assessment of PK of AK127+AK104 include serum concentrations of AK127+AK104 at different timepoints after treatment administration.

  8. Number of subjects who develop detectable anti-drug antibodies (ADAs) [ Time Frame: From first dose of treatment through to 90 days after end of treatment ]
    The immunogenicity of AK127+AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).


Eligibility Criteria
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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:

  1. Written and signed informed consent
  2. In Phase 1a, patients with relapsed or refractory advanced solid malignancies
  3. In Phase 1b, patients must have received no more than three prior lines of systemic therapy
  4. Subject must have at least one measurable lesion according to RECIST Version1.1.
  5. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
  6. Available archived or fresh tumor tissue
  7. Adequate organ function.
  8. For dose-expansion cohorts (Phase 1b), subjects must be willing to provide two fresh biopsy samples (pre-treatment and on treatment), where clinically appropriate.
  9. Females of childbearing potential and non-sterilized males who are sexually active must use an effective method of contraception from screening until 120 days after final dose of investigational product.

Exclusion Criteria:

  1. History of severe hypersensitivity reactions to other mAbs.
  2. Subjects with a condition requiring systemic treatment with either corticosteroid (> 10 mg daily ) or other immunosuppressive medications within 2 weeks of study drug administration.
  3. Prior use of approved or investigational anti-TIGIT, anti-PVRIG, or anti-CD96 therapy
  4. Receiving any Other anticancer therapy (e.g., chemotherapy, radiotherapy, biologic or hormonal therapy for cancer treatment. etc.) within 4 weeks prior to the first dose of treatment
  5. Any major surgery within 4 weeks prior to the first dose of treatment
  6. Receiving agents with immunomodulatory effect within 2 weeks prior to the first dose of treatment.
  7. Active or prior documented inflammatory bowel disease
  8. History of organ transplant.
  9. History of interstitial lung disease, noninfectious pneumonitis except for those induced by radiation therapies.
  10. Known active hepatitis B or C infections or history of HIV.
  11. Receipt of live attenuated vaccines within 4 weeks prior to the first dose of investigational product.
  12. Patients with severe heart and lung dysfunction.
Contacts and Locations
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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): NCT05021120


Contacts
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Contact: Baiyong Li +86 (0760) 8987 3999 global.trials@akesobio.com
Contact: Dennis Xia global.trials@akesobio.com

Locations
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Australia
Ashford Cancer Centre Research Recruiting
Adelaide, Australia
Austin Health Recruiting
Melbourne, Australia
Monash Health Recruiting
Melbourne, Australia
Southside Cancer Care Centre Recruiting
Sydney, Australia
The Kinghorn Cancer Centre, St Vincents Hospital Sydney Recruiting
Sydney, Australia
Sponsors and Collaborators
Akesobio Australia Pty Ltd
More Information
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Responsible Party: Akesobio Australia Pty Ltd
ClinicalTrials.gov Identifier: NCT05021120    
Other Study ID Numbers: AK127-101
First Posted: August 25, 2021    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: January 2023
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