A Phase 1 interventional study of AK127 in Advanced Solid Tumors, sponsored by Akeso. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-05-26.
Sponsored by Akeso · Phase 1, Interventional, and Treatment
This study is to characterize the safety, tolerability and anti-tumor activity of AK127 as a single agent in adult subjects with advanced solid tumor malignancies.
This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK127 as a single agent in adult subjects with advanced solid tumor malignancies. The study, as a dose escalation phase is to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for AK127 as a single agent, and describe Dose Limiting Toxicity (DLT).
Akeso is the lead sponsor of 154 studies on the registry; 67 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will receive AK127 by intravenous administration
Drug: AK127
Subjects will receive AK127 by intravenous administration（administered on Day 1 of each cycle, Q3W）
Also known as: Subjects will receive AK127 by intravenous administration
Number of participants with adverse events (AEs)
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
Time frame: From the subject signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first
Number of participants with a Dose Limiting Toxicity (DLT)
DLTs will be assessed during the first 21 days of treatment for dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected or definite relationship to study drug
Time frame: During the first 21 days
PFS
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first assessed by investigator Per RECIST 1.1.
Time frame: Up to 2 years
ORR
Efficacy measures such as overall response rate (ORR), which is the proportion of subjects with CR or PR by IRRC based on RECIST v1.1
Time frame: Up to 2 years
DCR
Disease control rate (DCR), which is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1
Time frame: Up to 2 years
DOR
Duration of response (DoR), which is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first
Time frame: Up to 2 years
TTR
TTR is defined as the time to response base on RECIST v1.1
Time frame: Up to 2 years
Area under the Concentration-Time Curve (AUC) of AK127
The endpoints for assessment of PK of AK127 include serum concentrations of AK127 at different timepoints after AK127 administration
Time frame: Cycle 1 and 4: Predose, Post-dose-5min,2 hours, 24 hours, Day 4,8 and 15; Cycle 2,3,5,6: Predose and Post-dose-5min; then Predose at Day 1, every 2 cycles (cycle length 21 days),Day30 after last dose; Up to 2 years and 1 months
Maximum observed concentration (Cmax) of AK127
The endpoints for assessment of PK of AK127 include serum concentrations of AK127 at different timepoints after AK127 administration
Time frame: Cycle 1 and 4: Predose, Post-dose-5min,2 hours, 24 hours, Day 4,8 and 15; Cycle 2,3,5,6: Predose and Post-dose-5min; then Predose at Day 1, every 2 cycles (cycle length 21 days),Day30 after last dose; Up to 2 years and 1 months
Minimum observed concentration (Cmin) of AK127 at steady state
The endpoints for assessment of PK of AK127 include serum concentrations of AK127 at different timepoints after AK127 administration
Time frame: Cycle 1 and 4: Predose, Post-dose-5min,2 hours, 24 hours, Day 4,8 and 15; Cycle 2,3,5,6: Predose and Post-dose-5min; then Predose at Day 1, every 2 cycles (cycle length 21 days),Day30 after last dose; Up to 2 years and 1 months
Number and Percentage of Subjects with Anti-Drug Antibodies(ADAs) to AK127
The immunogenicity of AK127 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: Predose on Day 1 at Cycle 1-6, then Predose at Day 1, every 2 cycles,Day30 after last dose; Up to 2 years and 1 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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