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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

NCT05104905 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2022-05-11

No results posted yet for this study

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

  • Carcinoma, Renal Cell
  • Carcinoma Colon

Interventions

DRUG

bexmarilimab

A single neoadjuvant dose will be administered prior to surgery.

Sponsors & Collaborators

Principal Investigators

  • Peter Boström · Turku University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-07
Primary Completion
2022-01-28
Completion
2022-01-28

Countries

  • Finland

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05104905 on ClinicalTrials.gov