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A Study of KNT-0916 in Treatment of Unresectable or Metastatic Solid Tumors with FGFR2 Alterations

NCT06800196 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2025-01-29

No results posted yet for this study

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).

Conditions

  • Solid Tumors with FGFR2 Alterations, Adult

Interventions

DRUG

KNT-0916

• KNT-0916 is an oral inhibitor of FGFR2.

Sponsors & Collaborators

  • KinoTeck Therapeutics Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Ruihua Xu · Sun Yat-sen University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2027-09-30
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06800196 on ClinicalTrials.gov