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

NCT04202705 | Completed Phase 1 DMC

• 1 other identifier: SYD1875.001
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 3

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.

Conditions

Solid Tumor

Keywords

ADC; 5T4; solid tumors; duocarmycin

Outcome Measures

Primary Outcomes (1)

• Incidence of dose-limiting toxicities

  Part 1

  21 days

Secondary Outcomes (1)

• Objective response rate

  21 days

Study Arms (1)

SYD1875

EXPERIMENTAL

5T4-targeting Antibody-Drug Conjugate

Drug: SYD1875

Interventions

SYD1875 DRUG

SYD1875 IV (in the vein) infusion every three weeks. Number of cycles: until cancer progression or unacceptable toxicity develops. Different doses.

SYD1875

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Having been treated with:
• T4-targeting therapy at any time
• Trastuzumab duocarmazine (SYD985) at any time
• Other anticancer therapy within 4 weeks or as defined in the protocol
• 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

Sponsors & Collaborators

• Byondis B.V.: lead

Study Sites (3)

Institut Jules Bordet

Brussels, Belgium

Location

Institut Bergonié

Bordeaux, France

Location

Centre Oscar Lambret

Lille, France

Location

Study Officials

• Ellen Mommers, PhD

  Byondis B.V., The Netherlands

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 17, 2019
• Study Start: February 28, 2020
• Primary Completion: June 22, 2022
• Study Completion: January 26, 2023
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); FR (2)