Status:
COMPLETED
First-in-human Study With the Antibody-drug Conjugate SYD985 to Evaluate Safety and Efficacy in Cancer Patients
Lead Sponsor:
Byondis B.V.
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
Cancer cells can have different kinds of proteins on their cell surface; one of these is the protein HER2. HER2 plays an important role in the development of cancer. High expression of HER2 is related...
Eligibility Criteria
Inclusion
- Main
- Patient with histologically-confirmed, locally advanced or metastatic tumor who has progressed on standard therapy or for whom no standard therapy exists, with the following restriction:
- Part I: solid tumors of any origin;
- Part II: breast, gastric, urothelial and endometrial tumors;
- For Part II: HER2 tumor status as defined in the protocol;
- ECOG performance status ≤ 1;
- Life expectancy \> 12 weeks;
- Adequate organ function;
- For Part II: measurable disease.
- Main
Exclusion
- Anthracycline treatment within 3 months and/or abnormal cardiac biomarker values;
- Other anticancer therapy (except for LHRH agonists) within 4 weeks (6 weeks for nitrosoureas and mitomycin C);
- History of infusion-related reactions and/or hypersensitivity to trastuzumab or (ado-) trastuzumab emtansine;
- Severe, uncontrolled systemic disease;
- LVEF \< 55%, or a history of absolute decrease in LVEF of ≥ 10% points to \< 50% during previous treatment with trastuzumab or (ado-)trastuzumab emtansine, or a history of decrease in LVEF to \< 40% during previous treatment with trastuzumab or (ado-)trastuzumab emtansine;
- History of clinically significant CV disease;
- Symptomatic brain metastasis, or therapy for brain metastasis (excluding PCI and dexamethasone treatment with stable or decreasing daily dose) within 4 weeks.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT02277717
Start Date
October 1 2014
End Date
October 1 2019
Last Update
August 14 2023
Active Locations (15)
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1
UZ
Antwerp, Belgium
2
Institut Jules Bordet
Brussels, Belgium
3
UZ
Ghent, Belgium
4
NKI-AvL
Amsterdam, Netherlands