First-in-human Study With the Antibody-drug Conjugate SYD985 to Evaluate Safety and Efficacy in Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02277717|
Recruitment Status : Active, not recruiting
First Posted : October 29, 2014
Last Update Posted : February 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: SYD985 (trastuzumab vc-seco-DUBA)||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||185 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 2014|
|Actual Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: SYD985 (trastuzumab vc-seco-DUBA)
HER2-targeting Antibody-Drug Conjugate
Drug: SYD985 (trastuzumab vc-seco-DUBA)
IV (in the vein) infusion every three weeks. Number of Cycles: until cancer progression or unacceptable toxicity develops. Different doses.
- Incidence of dose-limiting toxicities [ Time Frame: 21 days ]first cycle
- Number of patients with adverse events [ Time Frame: up to 2 years ]
- Area under the plasma concentration versus time curve (AUC) of SYD985 [ Time Frame: 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 ]
- Peak plasma concentration of SYD985 [ Time Frame: 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 ]
- Change from baseline in hematology and blood chemistry parameters [ Time Frame: Baseline and every cycle up to 2 years ]
- Number of patients with antibodies against SYD985 [ Time Frame: Baseline and every cycle up to 2 years ]
- Objective response rate [ Time Frame: Baseline and every two cycles up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277717
|Institut Jules Bordet|
|Institut Catala d'Oncologia|
|Vall d'Hebron University Hospital|
|Beatson Institute for Cancer Research|
|Glasgow, United Kingdom|
|The Christie NHS Foundation Trust|
|Manchester, United Kingdom|
|Oxford, United Kingdom|
|Royal Marsden / Institute of Cancer Research|
|Sutton, United Kingdom|
|Study Director:||Ellen Mommers, PhD||Synthon Biopharmaceuticals|