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Clinical Trial Summary

The Phase I trial is planned to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of MBS8(1V270) in subjects with advanced solid tumours. The trial is designed to provide data for further clinical development of MBS8(1V270)

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04855435
Study type Interventional
Source MonTa Biosciences ApS
Contact Simon S Jensen, PhD
Phone +45 5118 630
Email [email protected]
Status Recruiting
Phase Phase 1
Start date April 12, 2021
Completion date November 2022

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