Status:
COMPLETED
A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy or in Combination With AK104
Lead Sponsor:
Akesobio Australia Pty Ltd
Conditions:
Neoplasms Malignant
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This was a first-in-human, Phase 1 study designed to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK117 as monotherapy or in combinati...
Detailed Description
The study was conducted across 2 parts. Part A of the study was the dose escalation part of AK117 monotherapy as priming dose to evaluate the safety and tolerability of AK117 weekly dosing in solid tu...
Eligibility Criteria
Inclusion
- Able to provide written and signed informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
- Life expectancy ≥12 weeks
- 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 or women of non-childbearing potential.
- Willing to receive blood transfusion(s) when so advised by the investigator.
- Adequate organ function.
- Subjects must have a histologically or cytologically confirmed advanced solid tumor that is refractory or relapsed to the current standard therapies or which no effective standard therapy is available.
- At least 1 measurable lesion according to RECIST v1.1
Exclusion
- Concurrent enrollment in another clinical study excluding observational trials
- Prior malignancy active within the previous 3 years except for the tumor for which a subject is enrolled in the study
- Active brain/central nervous system (CNS) metastases
- Active infections requiring systemic therapy within 2 weeks prior to the first dose of investigational product.
- Known history of HIV.
- Known active hepatitis B or C infections
- Active or prior documented autoimmune disease that may relapse.
- History of interstitial lung disease or non-infectious pneumonitis, except those induced by radiation therapies.
- History of defects in RBC production, or hemoglobin production or metabolism
- Patients with clinically significant cardio-cerebrovascular disease.
- History of severe hypersensitivity reactions to other mAbs.
- History of organ transplantation.
- Receiving any anticancer therapy targeting the CD47/SIRPα ; Anticancer small molecule targeted agent within 2 weeks prior to the first dose of the investigational product; Anticancer mAbs within 6 weeks prior to the first dose of investigational product or 5 half-lives (whichever is lesser); Other anticancer therapy within 4 weeks prior to the first dose of the investigational product;
- Subjects with a condition requiring systemic treatment with either corticosteroid (\>10 mg daily doses)) or other immunosuppressive medications within 2 weeks prior to the first dose of investigational product.
- Received a live attenuated vaccine within 4 weeks prior to the first dose of investigational product.
Key Trial Info
Start Date :
April 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2022
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04349969
Start Date
April 23 2020
End Date
November 8 2022
Last Update
August 21 2024
Active Locations (4)
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1
Blacktown Hospital
Sydney, New South Wales, Australia
2
ICON Cancer Foundation
South Brisbane, Queensland, Australia
3
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia
4
Austin Health
Heidelberg, Victoria, Australia