NCT05631262

SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors

A Multicenter, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 321 (actual)
• Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of SKB264 monotherapy in subjects with selected advanced solid tumors.The study is divided into two parts: the Part Ⅰ consists of 5 cohorts, and the Part Ⅱ for expansion. Eligible subjects will receive SKB264 monotherapy, until there is no longer clinical benefit, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.

Detailed description

The second part of this study is a randomized, open-label, multicenter Phase 2 clinical study of SKB264 monotherapy versus docetaxel in subjects with locally advanced or metastatic non-squamous NSCLC.

Conditions

• Selected Subjects With Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	SKB264	Subjects of Cohot 1-5 and Part II Test group will receive SKB264 monotherapy
DRUG	Docetaxel	Part II Control group will receive docetaxel monotherapy.

Timeline

• Start date: 2022-11-30
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2022-11-30
• Last updated: 2026-02-13

Locations

1 site across 1 country: China