Status:
UNKNOWN
A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK114
Lead Sponsor:
Akeso
Conditions:
Advanced or Metastatic Solid Tumors
Malignancy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK114.
Detailed Description
This is a first-in-human (FIH), Phase 1a, multicenter, open-label, single-arm dose-escalation study of AK114 to evaluate the safety, tolerability, PK, pharmacodynamics, antitumor activity and immunoge...
Eligibility Criteria
Inclusion
- Written and signed informed consent
- Age ≥ 18
- Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor
- Subject must have at least one measurable lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1
- At the time of Day 1 of the study, subjects with central nervous system (CNS) metastases must have been treated
- Available archived tumor tissue sample (block or a minimum of 10 unstained slides of formalin-fixed paraffin-embedded tissues) to allow for correlative biomarker studies
- Subjects may opt to provide two fresh biopsy samples (pretreatment and on treatment), where clinically appropriate
- Adequate organ function
- Use acceptable method of contraception from screening, and must agree to continue for 120 days after the final dose of investigational product
Exclusion
- History of severe hypersensitivity reactions to other monoclonal antibodies
- History or concurrent gastrointestinal perforation, surgery and wound healing complications, hemorrhage events
- Patients with clinically significant cardiovascular disease
- Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of investigational product administration
- Active or prior documented autoimmune disease within the past 2 years
- History of primary immunodeficiency
- History of organ transplant or hematopoietic stem cell that requires use of immunosuppressive medications
- Known allergy or reaction to any component of the investigational product formulation.
- History of interstitial lung disease or noninfectious pneumonitis except for those induced by radiation therapies.
- Prior treatment with canakinumab.
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05200273
Start Date
March 15 2022
End Date
December 30 2023
Last Update
January 20 2022
Active Locations (1)
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1
Ashford Cancer Centre
Kurralta Park, South Australia, Australia