DS8201a:Pembrolizumab in HER2-Expressing Adv/MetastaticBreast or NSCLC
Research type
Research Study
Full title
A PHASE 1b, MULTICENTER, TWO-PART, OPENLABEL STUDY OF TRASTUZUMAB DERUXTECAN, AN ANTI-HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR-2 (HER2)-ANTIBODY DRUG CONJUGATE (ADC), IN COMBINATION WITH PEMBROLIZUMAB, AN ANTI-PD-1 ANTIBODY, IN SUBJECTS WITH LOCALLY ADVANCED/METASTATIC BREAST OR NON-SMALL CELL LUNG CANCER (NSCLC)
IRAS ID
263796
Contact name
Sanjaykumar Popat
Contact email
Sponsor organisation
Daiichi Sankyo, Inc.
Eudract number
2018-002489-38
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
127553, IND Number
Duration of Study in the UK
1 years, 7 months, 6 days
Research summary
This study is being carried out to see if a potential new drug called trastuzumab deruxtecan (referred to as “the study drug”) is effective and safe in treating types of breast or Non-Small Cell Lung Cancer (NSCLC) when combined with an existing drug, Pembrolizumab, which is an antibody drug conjugate, which means it is made up of 2 parts: a drug and an antibody (which is a type of protein). The antibody part binds to cancer cells that have the HER2 receptor and delivers the drug part into the cancer cell. HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. DS-8201a is an investigational drug.
This study is open to male or female participants >18, participants will be seen in a hospital setting & study last for approximately 30 months (2.5 years).
This study will be conducted in 2 parts. Study drug (trastuzumab deruxtecan) will be given in combination with Pembrolizumab in Part 1 and Part 2 of the study and participants with advanced breast and NSCLC will be enrolled in Part 1 and Part 2.
Dose-finding stage (Part 1), the amount of trastuzumab deruxtecan given will be based on when a participant enrols in the study. Participants in Part 1 should meet the inclusion and exclusion criteria corresponding to 1 of the expansion cohorts regard to HER2 status. Escalating doses of trastuzumab deruxtecan in combination with pembrolizumab will be assessed. Trastuzumab deruxtecan and pembrolizumab 200 mg will be administered on Day 1 of every 21-day cycle.
Part 2 - (Dose Expansion) on completion of Dose escalation (Part 1) will occur after the Sponsor and study doctors find the best dose in Part 1.
Study Part 1 and Part 2 are divided into 3 periods: screening, treatment, and follow up.
REC name
London - Chelsea Research Ethics Committee
REC reference
20/LO/0019
Date of REC Opinion
21 Feb 2020
REC opinion
Further Information Favourable Opinion