NCT05265091

A Study of KL590586 in Patients With Advanced Solid Tumors

An Open, Multi-Center Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetic Characteristics And Effectiveness Of KL590586 Capsules In Patients With Advanced Solid Tumors Carrying RET Fusion Or Mutant Genes

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 414 (estimated)
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An Open, Multi-Center Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetic Characteristics And Effectiveness Of KL590586 Capsules In Patients With Advanced Solid Tumors Carrying RET Fusion Or Mutant Genes

Detailed description

This is an open, multicentre phase I/II study. To evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic properties and efficacy of KL590586 in patients with advanced NSCLC, MTC and other solid tumours carrying a RET fusion or mutation gene. Phase I of this study includes a dose-escalation phase and a dose-expansion phase (as needed), which will focus on exploring MTD and/or RP2D of KL590586 in patients with advanced solid tumours; Phase II will assess the efficacy and safety of KL590586 in different cohorts (NSCLC, MTC and other tumour types carrying RET fusions or mutations) of solid tumour patients at the RP2D dose.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	KL590586 Capsule	Product Name: KL590586 Capsules Formulation：Capsule Specification: 10mg; 50mg Ingredients: KL590586, microcrystalline cellulose, mannitol, cross-linked sodium carboxymethylcellulose, colloidal silicon dioxide, magnesium stearate, hydroxypropylmethylcellulose hollow capsule

Timeline

• Start date: 2021-09-15
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-03-03
• Last updated: 2025-12-18

Locations

1 site across 1 country: China