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A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate SYD1875

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04202705
Recruitment Status : Recruiting
First Posted : December 17, 2019
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Byondis B.V.

Brief Summary:
This is the first-in-human study with SYD1875, an antibody-drug conjugate (ADC) comprising of a humanized IgG1 monoclonal antibody directed against the 5T4 oncofetal antigen covalently conjugated to a duocarmycin-based linker-drug. This study includes a dose-escalation part (Part 1) in which the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) will be determined, and an expansion part (Part 2) to evaluate efficacy and safety in specific patient cohorts.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: SYD1875 Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: SYD1875
5T4-targeting Antibody-Drug Conjugate
Drug: SYD1875
SYD1875 IV (in the vein) infusion every three weeks. Number of cycles: until cancer progression or unacceptable toxicity develops. Different doses.




Primary Outcome Measures :
  1. Incidence of dose-limiting toxicities [ Time Frame: 21 days ]
    Part 1


Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: 21 days ]
    Part 2



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Ellen Mommers, PhD +31 (0)24 679 5100 clinicaltrials@byondis.com

Locations
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Belgium
Institut Jules Bordet Recruiting
Brussels, Belgium
Contact: Nuria Kotecki, MD         
France
Institut Bergonié Recruiting
Bordeaux, France
Contact: Antoine Italiano, MD         
Centre Oscar Lambret Recruiting
Lille, France
Contact: Nicolas Penel, MD         
Sponsors and Collaborators
Byondis B.V.
Investigators
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Study Director: Ellen Mommers, PhD Byondis B.V., The Netherlands
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Responsible Party: Byondis B.V.
ClinicalTrials.gov Identifier: NCT04202705    
Other Study ID Numbers: SYD1875.001
First Posted: December 17, 2019    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Byondis B.V.:
ADC
5T4
solid tumors
duocarmycin