AK112-101
13 evidence topics · 1 source
Objective
Primary clinical objective
Location and study date
Study setting: Australia
Enrollment dates reported in the publication
| Date element | Quoted date |
|---|---|
| Enrollment start | “October 2, 2019” |
| Enrollment end in the abstract | “January 14, 2021” |
| Enrollment end in the results section | “June 14, 2021” |
Study design
Phase 1a dose escalation study
Dose-escalation design
Eligibility criteria
Disease population
Treatment
Study outcomes
Rationale for using treatment-emergent adverse events as the primary endpoint
Not applicable.
Statistical analysis description
Number of participants (Planned and analyzed)
Enrolled participants
Description of analysis sets
Statistical approach
Results
Participant disposition
Participants with at least one postbaseline tumor assessment
Baseline characteristics
Efficacy results
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Grade 3 or higher treatment-related adverse events
Study limitations
Summary
The study enrolled 51 participants with advanced solid tumors, with 47 contributing a postbaseline response assessment. Descriptive dose-escalation findings do not establish efficacy specifically in EGFR-mutated NSCLC. The publication gives different enrollment end dates in its abstract and results section; neither date has been silently substituted for the other. The maximum tolerated dose is specific to this study and schedule.