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A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate SYD1875

NCT04202705 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-01-30

No results posted yet for this study

Summary

This is the first-in-human study with SYD1875, an antibody-drug conjugate (ADC) comprising of a humanized IgG1 monoclonal antibody directed against the 5T4 oncofetal antigen covalently conjugated to a duocarmycin-based linker-drug. This study includes a dose-escalation part (Part 1) in which the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) will be determined, and an expansion part (Part 2) to evaluate efficacy and safety in specific patient cohorts.

Conditions

Interventions

DRUG

SYD1875

SYD1875 IV (in the vein) infusion every three weeks. Number of cycles: until cancer progression or unacceptable toxicity develops. Different doses.

Sponsors & Collaborators

  • Byondis B.V.

    lead INDUSTRY

Principal Investigators

  • Ellen Mommers, PhD · Byondis B.V., The Netherlands

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-28
Primary Completion
2022-06-22
Completion
2023-01-26

Countries

  • Belgium
  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT04202705 on ClinicalTrials.gov