SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors

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.

NCT Number	NCT05631262
Lead Sponsor	Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions	Selected Subjects With Advanced Solid Tumors
Enrollment	321 participants
Start Date	2022-11-30
Primary Completion	2026-12-30 (estimated)
Study Completion	2026-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-08