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
SYD1875
Treatment Study
Summary
Study start date: February 28, 2020
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.31 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Main Inclusion Criteria: * Patient with histologically-confirmed, locally advanced or metastatic cancer who has progressed on standard therapy or for whom no standard therapy exists, with the following restriction: * Part 1: solid tumours of any origin * Part 2: three patient cohorts * Tumour 5T4 membrane staining according protocol * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1; * Adequate organ function * For Part 2: measurable disease Main Exclusion Criteria: * Having been treated with: 1. 5T4-targeting therapy at any time 2. Trastuzumab duocarmazine (SYD985) at any time 3. Other anticancer therapy within 4 weeks or as defined in the protocol 4. Hormone therapy within 1 week * History or presence of keratitis, clinically significant renal disease, lung disease, or cardiovascular disease as specified in the protocol * Symptomatic brain metastases, brain metastases requiring steroids or treatment for brain metastases within 8 weeks
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Institut Bergonié
Bordeaux, FranceCentre Oscar Lambret
Lille, France