At a glance
ClinicalIndex Comparison RecordPhase 1Not Yet Recruiting· 151 target
Drug / intervention
KNT-0916drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I, Multicenter, Open-label Study to Evaluate the Safety, Pharmacokinetics, Preliminary Efficacy of KNT-0916 in Subjects with Unresectable or Metastatic Solid Tumors with FGFR2 Alterations
In Brief
A Phase 1 clinical trial evaluating KNT-0916 for Solid Tumors with FGFR2 Alterations, Adult. Not yet recruiting, targeting 151 participants.
Detailed Summary
This is a Phase1, open-label, dose escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of KNT-0916 in patients with unresectable or metastatic solid tumors harboring FGFR2 alterations who have failed prior systemic therapy. This study is divided into 2 parts, dose escalation part(part A), dose expansion part(partB).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--
Timeline
Phase 1Not Yet Recruiting
2025202620272028
First PostedJan 2025
Enrollment StartMar 2025
TodayJul 2026
Primary CompletionSep 2027
Study CompletionDec 2027
First PostedJan 29, 2025
Enrollment StartMar 31, 2025
Primary CompletionSep 30, 2027
Study CompletionDec 31, 2027
TodayJul 1, 2026
Enrollment to primary: 2.5 yearsPosted 1.4 years agoPrimary completion in 1.2 years
Interventions
KNT-0916drug
• KNT-0916 is an oral inhibitor of FGFR2.