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ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer

NCT04602117 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-11-18

No results posted yet for this study

Summary

This is an open-label, single-arm, multi-site phase I/Ib trial with SYD985, an antibody-drug conjugate (ADC) targeting HER2 on the cell membrane, combined with paclitaxel.

Conditions

Interventions

DRUG

Vic-trastuzumab duocarmazine (SYD985) + paclitaxel

SYD985 (\[vic-\]trastuzumab duocarmazine) an antibody-drug conjugate or ADC being developed by Byondis B.V. (Nijmegen, The Netherlands), consists of the recombinant humanized anti-epidermal growth factor receptor 2 (HER2) monoclonal antibody trastuzumab linked, via a cleavable linker, to the duocarmycin prodrug, seco-duocarmycin-hydroxybenzamide-azaindole or seco-DUBA, which has potent antineoplastic activity. Eligible patients will receive infusions of SYD985 every three weeks and of paclitaxel weekly.

Sponsors & Collaborators

  • Byondis B.V.

    collaborator INDUSTRY

  • QuantumLeap Healthcare Collaborative

    lead OTHER

Principal Investigators

  • Paula R Pohlmann, MD, MSc, PhD · M.D. Anderson Cancer Center

  • Anthony Elias, MD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-28
Primary Completion
2021-11-17
Completion
2021-11-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04602117 on ClinicalTrials.gov