WHO ICTRP trial

Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With…

EUCTR2017-002289-35-ES · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2017-002289-35-ES
Public title Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer
Scientific title Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination with Pembrolizumab for First-Line Treatment of Patients with Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer
Primary sponsor Seattle Genetics, Inc.
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries France;United States;Spain;Germany;Italy
Conditions Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer MedDRA version: 20.0 Level: LLT Classification code 10072740 Term: Locally advanced breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and…
Interventions Product Name: Ladiratuzumab vedotin Product Code: SGN-LIV1A Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: ladiratuzumab vedotin CAS Number: 1629760-29-7 Current Sponsor code: SGN-LIV1A Other descriptive…
Registration date Feb 2, 2018
Target size 72
Secondary IDs SGNLVA-002
Registry page clinicaltrialsregister.eu

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