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

KinoTeck Therapeutics Co., Ltd

Status and phase: Not yet enrolling; Phase 1

Conditions: Solid Tumors with FGFR2 Alterations, Adult

Treatments: Drug: KNT-0916

Study type: Interventional

Funder types: Industry

Identifiers

NCT06800196

EO002-CP002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 151 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

151 participants in 2 patient groups

Part A - dose escalation

Experimental group

Description:

Dose escalation of KNT-0916 in patients with advanced solid tumors.

Treatment:

Drug: KNT-0916

Part B - expansion

Experimental group

Description:

Oral dose of KNT-0916 as determined during Part A Dose Escalation.

Treatment:

Drug: KNT-0916