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 tumours.
- Conditions
- locally advanced or metastatic solid tumourscancermalignant neoplasms
- Registration Number
- NL-OMON47853
- Lead Sponsor
- Synthon Biopharmaceuticals BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
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 <= 1
4. Life expectancy > 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.
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 < 55%, or a history of absolut decrease in LVEF of >= 10% points to <
50% during previous treatment with trastuzumab or trastuzumab emtansine, or a
history of decrease in LVEF to < 40% during previous treatment with trastuzumab
or trastuzumab emtansine
6. History of clinically significant CV disease
7. Symptomatic brain metastases, or therapy for brain metastases (excluding PCI
and dexamethasone treatment with stable or decreasing daily dose) within 4
weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part I: incidence of Dose Limiting Toxicities and (serious) Adverse Events<br /><br>Part II: ORR</p><br>
- Secondary Outcome Measures
Name Time Method <p>- change in other safety parameters including vital signs and lab results<br /><br>- preliminary efficacy endpoints including clinical benefit rate, Duration of<br /><br>Response and Progression Free Survival<br /><br>- PK parameters including Cmax, AUC and T1/2<br /><br>- ORR<br /><br>- Quality of Life</p><br>