Clinical trial · Interventional
A Study of KNT-0916 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors With FGFR2 Alterations, Adult | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KNT-0916 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A - dose escalation
- description
- Dose escalation of KNT-0916 in patients with advanced solid tumors.
- interventionNames
- Drug: KNT-0916
- type
- EXPERIMENTAL
- label
- Part B - expansion
- description
- Oral dose of KNT-0916 as determined during Part A Dose Escalation.
- interventionNames
- Drug: KNT-0916
Primary outcomes (4)
- measure
- Dose-limiting Toxicity (DLT)
- timeFrame
- 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed unresectable or metastatic solid tumor * Documented FGFR2 gene fusion, mutation, or amplification per testing of blood and/or tumor * Patient must have measurable disease per RECIST v1.1 * Patient has ECOG performance status of 0-1 * Patient must have disease that is refractory to standard therapy, disease that has not adequately responded to standard therapy, disease for which standard or curative therapy does not exist, or the patient must be intolerant to or have declined standard therapy * An expected survival of ≥ 12 weeks. * Adequate organ function, as measured by laboratory values Exclusion Criteria: * Prior treatment with any FGFR2 target therapy. * Central nervous system metastasis with associated symptom and signs. * Clinically significant, uncontrolled cardiovascular disease. * History of interstitial lung disease, or infectious pneumonitis need heavy antibiotics therapy 5. As judged by the investigator, unsuitable for attending the study.
References
Publications (0)
Data not yet available