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Recruiting NCT06800196

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

Phase I Interventional Solid Tumors With FGFR2 Alterations, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KNT-0916.
Who it may be relevant to
Registry conditions: Solid Tumors With FGFR2 Alterations, Adult. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Detailed description

This study is divided into 2 parts, part a isNdesigned to explore the maximum toxicity dose (MTD) of KNT-0916 with an accelerated titration plus traditional "3+3" design; part b is designed to explore the elementary anti-neoplastic activity of KNT-0916 with recommended dose in patients with confirmed FGFR2 alterations through central laboratory testing.

Interventions

  • Drug KNT-0916
    • KNT-0916 is an oral inhibitor of FGFR2.

Primary outcome measures

  • Dose-limiting Toxicity (DLT) [Time frame: 4 weeks]
  • Maximum tolerated dose (MTD) or Maximum administered dose (MAD) [Time frame: 12 months]
  • Incidence, relatedness, seriousness and severity of adverse events (AEs) per the National Cancer Institute Common Terminology Criteria for AE (NCI CTCAE) Version 5.0. [Time frame: 33 months]
  • Recommended phase 2 dose (RP2D) [Time frame: 33 months]
Secondary outcome measures (10)
  • Objective response rate (ORR) assessed as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [Time frame: 33 months]
  • Duration of response (DoR) assessed as per RECIST 1.1 [Time frame: 33 months]
  • Disease control rate (DCR) assessed as per RECIST 1.1 [Time frame: 33 months]
  • Progression-free survival (PFS) assessed as per RECIST 1.1 [Time frame: 33 months]
  • Overall survival (OS) assessed as per RECIST 1.1 [Time frame: 33 months]
  • Pharmacokinetic parameters including maximum plasma drug concentration (Cmax) [Time frame: 33 months]
  • Pharmacokinetic parameters including area under the plasma concentration versus time curve (AUC) [Time frame: 33 months]
  • Pharmacokinetic parameters including half-life (t1/2) [Time frame: 33 months]
  • Pharmacokinetic parameters including time to maximum concentration (Tmax) [Time frame: 33 months]
  • Pharmacokinetic parameters including Apparent clearance (CL/F) [Time frame: 33 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-sen University Cancer Center — Guangzhou

Identifiers

NCT: NCT06800196 · EO002-CP002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗