NCT04602117 - ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer | Biotech Hunter

Timeline

Start Date

July 28, 2021

Primary Completion Date

November 17, 2021

Study Completion Date

November 17, 2021

Conditions

HER2-positive Breast CancerHER2 LowSYD-985SYD985Vic-trastuzumab DuocarmazineMetastatic CancerMetastatic Breast CancerMetastatic Gastrointestinal Carcinoid TumorMetastaticHER2 Low Breast CancerGastroEsophageal CancerGastroesophageal AdenocarcinomaEndometrium TumorOvarian CancerOvarian CarcinomaHER2-positive Gastric CancerHER2-positive Metastatic Breast CancerHER2 Mutation-Related TumorsHER-2 Protein OverexpressionHER2 Low HR PositiveHR PositiveHormone Receptor-positive Breast CancerEstrogen Receptor Positive TumorProgesterone Receptor-positive Breast CancerTriple Negative Breast CancerHormone Receptor Negative Breast CarcinomaBladder Cancer

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."

Trial Locations (1)

80045

University of Colorado Cancer Center, Aurora