A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate SYD1875
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|ClinicalTrials.gov Identifier: NCT04202705|
Recruitment Status : Recruiting
First Posted : December 17, 2019
Last Update Posted : July 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: SYD1875||Phase 1|
Cancer cells can have different kinds of proteins on their cell surface; one of these is the oncofetal antigen 5T4. 5T4 plays an important role in the development of cancer. Currently no drugs are available that work via the 5T4 antigen.
The new cancer drug SYD1875 is being developed by Byondis B.V. SYD1875 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 5T4 on the surface of the cancer cell. When SYD1875 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, SYD1875 can be considered as a form of targeted chemotherapy.
This is the first study in which SYD1875 is administered to humans. The study consists of two parts:
Part 1 is the dose-escalation part in which a low dose of SYD1875 is given to cancer patients. If it is well tolerated, a higher dose of SYD1875 will be given to other cancer patients until the maximum tolerated dose is reached.
In Part 2 of the study, groups of patients with a specific type of cancer will receive the SYD1875 dose which has been selected for further evaluation.
All patients from both parts of the study will receive SYD1875 infusions every three weeks until progression of the cancer or unacceptable toxicity develops.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate SYD1875 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With 5T4-expressing Locally Advanced or Metastatic Solid Tumours|
|Actual Study Start Date :||February 28, 2020|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2024|
5T4-targeting Antibody-Drug Conjugate
SYD1875 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 ]Part 1
- Objective response rate [ Time Frame: 21 days ]Part 2
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): NCT04202705
|Contact: Ellen Mommers, PhD||+31 (0)24 679 email@example.com|
|Institut Jules Bordet||Recruiting|
|Contact: Nuria Kotecki, MD|
|Contact: Antoine Italiano, MD|
|Centre Oscar Lambret||Recruiting|
|Contact: Nicolas Penel, MD|
|Study Director:||Ellen Mommers, PhD||Byondis B.V., The Netherlands|