NCT04713891

A Study of KF-0210 in Advanced Solid Tumors Patients

A Phase I, Multi-Center, Open-Label Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of KF-0210 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Keythera Pharmaceuticals (Australia) Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase I, Multi-Center, Open-Label Study is to evaluate the safety, tolerability, Pharmacokinetics, Pharmacodynamics and anti-tumor activity of KF-0210 in participants with advanced solid tumors. The study will be conducted in two parts: phase Ia, and phase Ib.

Detailed description

Phase 1a: The primary objective of the phase 1a part of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic and anti-tumor activity of oral KF-0210 as a single agent in participants with advanced solid tumors, to identify the dose-limiting toxicity and establish the maximum tolerated dose, or maximum administered dose and/or the recommended Phase II dose of KF-0210 in participants with advanced solid tumors. Phase 1b: The primary objective of the phase 1b part of the study is to assess the safety, pharmacokinetics, pharmacodynamic and anti-tumor activity of KF-0210 in combination with Atezolizumab in patients with colorectal cancer (CRC) (MSS), lung cancer (LC), squamous cell carcinoma of the esophagus (SCCE), gastric cancer (GC), and bladder cancer (BC).

Conditions

• Advanced Solid Tumor
• Colorectal Cancer
• Lung Cancer
• Squamous Cell Carcinoma of the Esophagus
• Gastric Cancer
• Bladder Cancer

Interventions

Type	Name	Description
DRUG	KF-0210 tablets, 120 mg	KF-0210 tablet will be orally administered as a single agent at 120 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal.
DRUG	KF-0210 tablets, 240 mg	KF-0210 tablet will be orally administered as a single agent at 240 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal.
DRUG	KF-0210 tablets, 450 mg	KF-0210 tablet will be orally administered as a single agent at 450 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal.
DRUG	KF-0210 tablets, 600 mg	KF-0210 tablet will be orally administered as a single agent at 600 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal.
DRUG	KF-0210 (dosage RP2D-2) + Atezolizumab	KF-0210 tablet will be orally administered at dosage RP2D-2 once daily (QD) in combination with Atezolizumab that will be administered at 1200 mg every 3 weeks via intravenously infusion.
DRUG	KF-0210 (dosage RP2D-1) + Atezolizumab	KF-0210 tablet will be orally administered at dosage RP2D-1 once daily (QD) in combination with Atezolizumab that will be administered at 1200 mg every 3 weeks via intravenously infusion.
DRUG	KF-0210 (dosage RP2D) + Atezolizumab	KF-0210 tablet will be orally administered at dosage RP2D once daily (QD) in combination with Atezolizumab that will be administered at 1200 mg every 3 weeks via intravenously infusion.

Timeline

• Start date: 2021-03-09
• Primary completion: 2022-12-08
• Completion: 2023-04-27
• First posted: 2021-01-19
• Last updated: 2024-09-24

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study