WHO ICTRP trial

A study of investigational medicinal product AL101 in adults with breast cancer

EUCTR2020-001979-33-GB · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2020-001979-33-GB
Public title A study of investigational medicinal product AL101 in adults with breast cancer
Scientific title A Phase 2, Multicenter, Open-label, Single-arm Study of AL101 Monotherapy in Patients with Notch-activated Triple Negative Breast Cancer - TENACITY
Primary sponsor Ayala Pharmaceuticals, Inc.
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries United States;France;Spain;Belgium;Israel;Netherlands;United Kingdom
Conditions Notch Activated Recurrent or Metastatic Triple Negative Breast Cancer MedDRA version: 20.0 Level: PT Classification code 10075566 Term: Triple negative breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified…
Interventions Product Code: AL101 Pharmaceutical Form: Solution for infusion INN or Proposed INN: - CAS Number: 1401066-79-2 Current Sponsor code: AL101 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number…
Registration date Sep 10, 2020
Target size 73
Secondary IDs AL-TNBC-01
Registry page clinicaltrialsregister.eu

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