The investigational medicinal product will be administered IV by infusion. Subjects will be treated in cycles.

MBS8(1V270)

Simon S Jensen, PhD

Steven Glazer, MD

Nuria Kotecki, MD dr.

Patrick Schöffski, prof. dr.

Kristoffer S Rohrberg, MD, PhD

Johannes W Pedersen, MD

Victor Moreno, MD PhD

Emiliano Calvo, MD PhD

Kristoffer S Rohrberg, MD PhD

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)

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 and the dose-limiting toxicity (DLT) observation period is 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.

Prospective, open-label, single arm, multinational, multicenter Phase I trial

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

A Phase I Multicentre, Open-label, Dose Escalation Study to Determine the Safety and Preliminary Efficacy of MBS8(1V270) Administered Intravenously to Cancer Patients With Advanced Solid Tumours

Dose limiting toxicities (DLTs) and the MTD for determination of RP2D of MBS8(1V270)

Plasma levels of safety related cytokines IL-6 and TNF-alpha wil be assessed

Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), unconfirmed (iUPD) and confirmed PD (iCPD), assessed according to Response Evaluation Criteria in Solid Tumours (RECIST) and immune RECIST (iRECIST

The length of time a subject lives with the disease but without progression

The plasma concentration time profile of MBS8(1V270) will be assessed

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours	NCT04855435	Advanced Solid ...	MBS8(1V270)	18 Years -	MonTa Biosciences ApS
Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours	NCT04855435	Advanced Solid ...	MBS8(1V270)	18 Years -	MonTa Biosciences ApS

Spots Global Cancer Trial Database for mbs8(1v270)

Every month we try and update this database with for mbs8(1v270) cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mbs8(1v270)

Every month we try and update this database with for mbs8(1v270) cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mbs8(1v270) cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.