TROPION-PanTumour03
Research type
Research Study
Full title
A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours (TROPION-PanTumor03)
IRAS ID
1005888
Contact name
Assim Khan
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2022-000776-19
Clinicaltrials.gov Identifier
Research summary
TROPION-PanTumor03 is a clinical study to learn more about the drug, Dato-DXd, when used alone and when used in combination with other anti-cancer drugs. The other anti-cancer drugs being used in this study are durvalumab, AZD5305, capecitabine, leucovorin, 5-flourouracil (5 FU), carboplatin, nivolumab, and bevacizumab. The study will also help to better understand different types of cancer types and associated health problems. There are 5 different cancer types being studied in this study including endometrial cancer, gastric cancer, prostate cancer, ovarian cancer, and colorectal cancer.
Some parts of this study are experimental, which means the study drug(s) have not been fully tested yet for these types of cancer. Dato DXd and AZD5305 are not approved by any health authority, except for use in research studies like this. Other anti cancer drugs Capecitabine and 5 FU are currently marketed drugs that are both approved for use in different types of cancers, but they’re not approved for use in combination with Dato-DxD.
Dato-DXd is a part of a class of targeted drugs, called an antibody-drug conjugate (ADC), with 2 parts and a link between the 2 parts. One part is an antibody called datopotamab that recognises cancer cells that have another protein called TROP2 on their surface. The second part of the study drug contains a chemotherapy-like molecule called deruxtecan. When the 2 drug parts bind to a TROP2 protein on a cancer cell, the chemotherapy-like part, DXd, gets internalised and released inside the cancer cell and damages or kills it.
This study is single arm, meaning, once participants are assigned to a treatment group, they will receive the study drug and will not be given a placebo or standard of care. Up to 550 study participants may take part in this study across many countries.REC name
South Central - Oxford A Research Ethics Committee
REC reference
22/SC/0288
Date of REC Opinion
26 Oct 2022
REC opinion
Further Information Favourable Opinion