Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Tubulin Modulators

Antimitotic Agents

SKB264 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle

Docetaxel will be administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle

Subjects of Cohot 1-5 and Part II Test group will receive SKB264 monotherapy

SKB264

Part II Control group will receive docetaxel monotherapy.

XiaoPing Jin

Li Zhang

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.

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.

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

ORR is defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR) as the best overall response assessed per RECIST 1.1.

Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

PFS is defined as the time from the first dose to progressive disease (PD) or death, whichever occurs first. PD will be assessed per RECIST 1.1.

DOR is defined as the time from the date of first documented CR or PR to PD or death due to any cause, whichever occurs first.

DCR is defined as the proportion of subjects with CR, PR or stable disease (SD) as the best overall response assessed per RECIST 1.1.

OS is defined as the time period from the start of administration to death due to any cause.

Presence of Anti-drug antibodys (ADAs) for SKB264.

Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of SKB264-ADC, SKB264-TAB and free KL610023.

Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) of SKB264-ADC, SKB264-TAB and free KL610023.

Spots Global Cancer Trial Database for selected subjects with advanced solid tumors