Solid Tumors Clinical Trial
Official title:
A Two Part First-in-human Phase I Study (With Expanded Cohorts) With the Antibody-drug Conjugate SYD985 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With Locally Advanced or Metastatic Solid Tumors
Verified date | August 2023 |
Source | Byondis B.V. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 185 |
Est. completion date | October 2019 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Main Inclusion Criteria: 1. 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; 2. For Part II: HER2 tumor status as defined in the protocol; 3. ECOG performance status = 1; 4. Life expectancy > 12 weeks; 5. Adequate organ function; 6. For Part II: measurable disease. Main Exclusion Criteria: 1. Anthracycline treatment within 3 months and/or abnormal cardiac biomarker values; 2. Other anticancer therapy (except for LHRH agonists) within 4 weeks (6 weeks for nitrosoureas and mitomycin C); 3. History of infusion-related reactions and/or hypersensitivity to trastuzumab or (ado-) trastuzumab emtansine; 4. Severe, uncontrolled systemic disease; 5. 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; 6. History of clinically significant CV disease; 7. Symptomatic brain metastasis, or therapy for brain metastasis (excluding PCI and dexamethasone treatment with stable or decreasing daily dose) within 4 weeks. |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ | Antwerp | |
Belgium | Institut Jules Bordet | Brussels | |
Belgium | UZ | Gent | |
Netherlands | NKI-AvL | Amsterdam | |
Netherlands | UMC | Groningen | |
Netherlands | Radboud UMC | Nijmegen | |
Netherlands | UMC | Rotterdam | |
Spain | Institut Catala d'Oncologia | Barcelona | |
Spain | Vall d'Hebron University Hospital | Barcelona | |
Spain | START Madrid-CIOCC | Madrid | |
Spain | START Madrid-FJD | Madrid | |
United Kingdom | Beatson Institute for Cancer Research | Glasgow | |
United Kingdom | The Christie NHS Foundation Trust | Manchester | |
United Kingdom | Churchill Hospital | Oxford | |
United Kingdom | Royal Marsden / Institute of Cancer Research | Sutton |
Lead Sponsor | Collaborator |
---|---|
Byondis B.V. |
Belgium, Netherlands, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of dose-limiting toxicities | first cycle | 21 days | |
Secondary | Number of patients with adverse events | up to 2 years | ||
Secondary | Area under the plasma concentration versus time curve (AUC) of SYD985 | Baseline, Days 1,2,3,4,8,15 of Cycle 1, Days 1,8,15 of Cycle 2, Day 1 of subsequent cycles up to 2 years | ||
Secondary | Peak plasma concentration of SYD985 | Baseline, Days 1,2,3,4,8,15 of Cycle 1, Days 1,8,15 of Cycle 2, Day 1 of subsequent cycles up to 2 years | ||
Secondary | Change from baseline in hematology and blood chemistry parameters | Baseline and every cycle up to 2 years | ||
Secondary | Number of patients with antibodies against SYD985 | Baseline and every cycle up to 2 years | ||
Secondary | Objective response rate | Baseline and every two cycles up to 2 years |
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