Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT05104905

A Phase I/II Open Label Single Centre Trial to Assess the Safety, Tolerability and Efficacy of Single Dose Neoadjuvant Anti-CLEVER-1 Antibody Bexmarilimab in Localised Renal Cell and Colon Carcinoma

A Phase I/II Open Label Single Centre Trial to Assess the Safety, Tolerability and Efficacy of Single Dose Neoadjuvant Anti-CLEVER-1 Antibody Bexmarilimab in Localised Renal Cell and Colon Carcinoma (Macrophage Antibody To Inhibit Immune Suppression in RENAl Cell and COLon Carcinomas)

Status
Withdrawn
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Faron Pharmaceuticals Ltd · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Bexmarilimab treatment has demonstrated tolerable safety profile and anticancer efficacy in some subjects with advanced malignancies. This is the first study to investigate the effect of single neoadjuvant dose of anti-CLEVER-1 antibody bexmarilimab prior to radical surgery of renal cell and colon cancers. We expect that the single dose will demonstrate measurable effects on the tumour immunological microenvironment as well as systemic effects on subject´s immunological status and that this evidence may be used to guide future neoadjuvant studies. There will be a dose escalation to investigate the effect of different doses of bexmarilimab. In addition to subjects receiving single neoadjuvant dose of bexmarilimab, there will be an observational cohort without Investigational Medicinal Product (IMP) for either cancer. All patients participating in the study (whether in investigational or observational cohort) will attend each visit and are assessed for the same endpoints.

Conditions

Interventions

TypeNameDescription
DRUGbexmarilimabA single neoadjuvant dose will be administered prior to surgery.

Timeline

Start date
2021-10-07
Primary completion
2022-01-28
Completion
2022-01-28
First posted
2021-11-03
Last updated
2022-05-11

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT05104905. Inclusion in this directory is not an endorsement.