Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours

Summary

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Description

This is a prospective, open-label, single arm, multinational, multicenter Phase I trial in subjects with advanced solid tumors. The trial consists of two stages: Stage I is a dose escalation stage which will include up to eight cohorts with escalating doses of MBS8(1V270) to establish the maximum to...

This is a prospective, open-label, single arm, multinational, multicenter Phase I trial in subjects with advanced solid tumors. The trial consists of two stages: Stage I is a dose escalation stage which will include up to eight cohorts with escalating doses of MBS8(1V270) to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D). Stage II is an expansion phase in which safety and tolerability of MBS8(1V270) will be assessed at the recommended phase 2 dose established in Stage I of the trial. The dose-escalation in stage 1 is based on the 1+2 design for the first cohort and on the 3+3 design for the following cohorts. The investigational medicinal product is a TLR7 agonist and will be administered intravenously by infusion. Subjects will be treated in cycles of 42 days. A treatment cycle consists of four MBS8(1V270) infusions administered Days 1, 8, 15, and 22, followed by a treatment pause of 21 days. The time period covering the first 4 doses of MBS8(1V270) plus one day will represent the dose-limiting toxicity (DLT) observation period (23 days). Plasma cytokine levels will be assessed, and tumor biopsies will be taken and evaluated. Radiological tumor assessment by MRI or CT will be performed. Safety will be evaluated by the incidence of adverse events (AEs), serious adverse events (SAEs), DLTs, and use of concomitant medications. Anti-tumor activity of MBS8(1V270) will be evaluated via imaging using RECIST and iRECIST criteria, with iRECIST being the leading tumor evaluation criteria.

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