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

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 Overview

• Status: Not yet recruiting
• Conditions: Solid Tumors with FGFR2 Alterations, Adult
• Intervention / Treatment: Drug: KNT-0916

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.

• Study Type: Interventional
• Enrollment (Estimated): 151
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lei Li; Phone Number: +86 13711344347; Email: lilei@kino-biotech.com
• Study Contact Backup: Name: Shaohua Chang; Phone Number: 0086-13621109316; Email: csh@kino-biotech.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A - dose escalation; Dose escalation of KNT-0916 in patients with advanced solid tumors.	Drug: KNT-0916; • KNT-0916 is an oral inhibitor of FGFR2.
Experimental: Part B - expansion; Oral dose of KNT-0916 as determined during Part A Dose Escalation.	Drug: KNT-0916; • KNT-0916 is an oral inhibitor of FGFR2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose-limiting Toxicity (DLT)	4 weeks
Maximum tolerated dose (MTD) or Maximum administered dose (MAD)	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.	33 months
Recommended phase 2 dose (RP2D)	33 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective response rate (ORR) assessed as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1	33 months
Duration of response (DoR) assessed as per RECIST 1.1	33 months
Disease control rate (DCR) assessed as per RECIST 1.1	33 months
Progression-free survival (PFS) assessed as per RECIST 1.1	33 months
Overall survival (OS) assessed as per RECIST 1.1	33 months
Pharmacokinetic parameters including maximum plasma drug concentration (Cmax)	33 months
Pharmacokinetic parameters including area under the plasma concentration versus time curve (AUC)	33 months
Pharmacokinetic parameters including half-life (t1/2)	33 months
Pharmacokinetic parameters including time to maximum concentration (Tmax)	33 months
Pharmacokinetic parameters including Apparent clearance (CL/F)	33 months

Collaborators and Investigators

• Sponsor: KinoTeck Therapeutics Co., Ltd
• Investigators: Principal Investigator: Ruihua Xu, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: EO002-CP002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No