A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy … (NCT04349969) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy or in Combination With AK104
Australia38 participantsStarted 2020-04-23
Plain-language 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 combination with AK104 in subjects with advanced or metastatic solid tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Incidence and nature of adverse events (AEs)
Timeframe: From the time of informed consent signed through 30 days after the last dose of AK117 as monotherapy or in combination with AK104
2
Number of participants with a Dose Limiting Toxicity (DLT)
Timeframe: During the first 4 weeks of first treatment dose of AK117 as monotherapy or during the first 3 weeks of treatment dose of AK117+AK104 as combination therapy.