Safety and efficacy of intratumourally administered INT230-6 in adult patients with advanced solid tumours: results from an open-label phase 1/2 dose escalation study.

ABSTRACT:

Background

Systemic chemotherapeutics have limited efficacy in many advanced solid tumours. This study evaluated the safety and tolerability of INT230-6, a unique intratumoural (IT) formulation of cisplatin, vinblastine, and 8-((2-hydroxybenzoyl)amino)octanoate (SHAO), an amphiphilic cell-penetration enhancer.

Methods

In this single-arm phase 1/2 trial (NCT03058289), adults with advanced or metastatic disease who progressed on a median of three prior therapies received multiple doses of IT INT230-6 monotherapy once every 28 days or biweekly for five treatments with maintenance dosing every 9 weeks. INT230-6 dose was based on tumour diameter or volume and escalated across five cohorts. A fixed-dose cohort received up to 175 mL.

Findings

No dose-limiting toxicities were

SUBMITTER: Thomas JS 

PROVIDER: S-EPMC12790145 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature