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
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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