locally advanced or metastatic solid tumours cancer
Conditions
Interventions
Investigational product: SYD985 will be administered every three weeks
(intravenous use).
Sponsors
Synthon Biopharmaceuticals BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient with histologically-confirmed, locally advanced or metastatic tumour who has progressed on standard therapy or for whom no standard therapy exists, whith the following restriction: - Part I: solid tumours of any origin - Part II: breast and gastric tumours, including adenocarcinomas of the gastroesophageal junction, urothelial and endometrial tumours; 2. For Part II: HER2 tumour status as defined in the protocol 3. ECOG performance status 12 weeks 5. Adequate organ function 6. For Part II: measurable disease 7. For Part II only: Presence of a tumour lesion accessible for biopsy and willingness to undergo a fresh tumour biopsy, unless biopsy material is available from a metastatic lesion obtained not more than 6 months prior to signing informed consent.
Exclusion criteria
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, trastuzumab emtansine 4. Severe, uncontrolled systemic disease 5. LVEF = 10% points to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part I: incidence of Dose Limiting Toxicities and (serious) Adverse Events Part II: ORR | — |
Secondary
| Measure | Time frame |
|---|---|
| - change in other safety parameters including vital signs and lab results - preliminary efficacy endpoints including clinical benefit rate, Duration of Response and Progression Free Survival - PK parameters including Cmax, AUC and T1/2 - ORR - Quality of Life | — |
Countries
Netherlands
Outcome results
None listed