First-in-human Study With the Antibody-drug Conjugate SYD985 to Evaluate Safety and Efficacy in Cancer Patients

NCT02277717 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2023-08-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of a new medicinal drug SYD985 at different dose levels in patients with cancer, to understand how SYD985 is handled by the body and to evaluate the effect of SYD985 on the cancer.

Conditions

Interventions

DRUG

SYD985 (trastuzumab vc-seco-DUBA)

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 · Synthon Biopharmaceuticals B.V., The Netherlands

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2019-01-31
Completion
2019-10-31

Countries

  • Belgium
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Entities

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 NCT02277717 on ClinicalTrials.gov