NCT06012708

Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KN510, KN713

An Open-label, Dose-escalation and Dose-finding, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KN510, KN713 as Combination Therapy in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: New Cancer Cure-Bio Co.,Ltd. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of the combination therapy of KN510 and KN713 and determine the MTD and RP2D in patients with advanced solid tumors.

Detailed description

It is expected that KN510 and KN713 will broaden the range of target patient groups and overcome resistance to the drugs in an innovative manner by targeting the common metabolic process of cancer cells, unlike existing targeted therapies whose application is limited depending on the presence of specific mutation and combination of mutations as they mainly target a single tyrosine kinase. In this study, the safety and tolerability of combination therapy of KN510 and KN713, including the dose limiting toxicity (DLT) and maximum tolerated dose (MTD), will be evaluated in patients with advance solid tumors and based on this, the recommended phase 2 dose (RP2D) will be determined.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	KN510 60mg/day + KN713 60mg/day	Once daily with 28 days (4 weeks) as one cycle.
DRUG	KN510 120mg/day + KN713 60mg/day	Once daily with 28 days (4 weeks) as one cycle.
DRUG	KN510 120mg/day + KN713 90mg/day	Once daily with 28 days (4 weeks) as one cycle.
DRUG	KN510 120mg/day + KN713 120mg/day	Once daily with 28 days (4 weeks) as one cycle.

Timeline

• Start date: 2023-09-11
• Primary completion: 2024-11-05
• Completion: 2024-12-16
• First posted: 2023-08-25
• Last updated: 2025-01-08

Locations

1 site across 1 country: South Korea