Description:
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.
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.
Completed
Phase 1
NCT ID: NCT02277717
ORG ID: SYD985.001
Solid Tumors
Drug | Synonyms | Arms |
---|---|---|
SYD985 (trastuzumab vc-seco-DUBA) | SYD985 (trastuzumab vc-seco-DUBA) |
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.
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 to poor prognosis. Although several cancer drugs are available that work via
the HER2 protein, a substantial portion of these patients still does not benefit from these
treatments.
The new cancer drug SYD985 is being developed by Synthon Biopharmaceuticals BV. SYD985 is an
antibody-drug conjugate and consists of two parts: an antibody and a linker-drug moiety
containing a toxin. The antibody part binds to HER2 on the surface of the cancer cell. When
SYD985 binds to this cancer cell, it will be internalized by the cell. After proteolytic
cleavage of the linker, the toxin will be split off in the cell and the cancer cell will be
killed. Thus, SYD985 can be considered as a form of targeted chemotherapy.
This is the first study in which SYD985 is administered to humans. The study consists of two
parts:
Part I is the dose-escalation part in which a low dose of SYD985 is given to three cancer
patients. If it is well tolerated, a higher dose of SYD985 will be given to 3 other cancer
patients. This will continue until a further dose increase is not safe anymore.
In Part II of the study, several groups of patients with a specific type of cancer will
receive the SYD985 dose which has been selected for further evaluation.
All patients from both parts of the study will receive SYD985 infusions every three weeks
until progression of the cancer or unacceptable toxicity develops.
Name | Type | Description | Interventions |
---|---|---|---|
SYD985 (trastuzumab vc-seco-DUBA) | Experimental | SYD985 (trastuzumab vc-seco-DUBA) |
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 and gastric 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
trastuzumab, (ado-)trastuzumab emtansine, 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.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Incidence of dose-limiting toxicities
Number of patients with adverse events
Area under the plasma concentration versus time curve (AUC) of SYD985
Peak plasma concentration of SYD985
Change from baseline in hematology and blood chemistry parameters
Number of patients with antibodies against SYD985
Objective response rate
cancer
metastasis
HER2
trastuzumab
duocarmycin
SYD985
antibody-drug conjugate
ADC
trastuzumab vc-seco-DUBA