Ph1/2 First in Human Safety, Tolerability, PK Ad Solid Tumors TPX-0005
Research type
Research Study
Full title
A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)
IRAS ID
260260
Contact name
Maxine Gauntlett
Contact email
Sponsor organisation
TP Therapeutics Inc
Eudract number
2016-003616-13
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
130465, IND Number
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
A gene is the basic physical and functional unit of heredity in living beings. Genes are set in a specific order. If there is a change in the specific order, this is known as a gene rearrangement or a gene mutation.
This study is testing a drug called repotrectinib and is being studied as a possible treatment for advanced or solid tumours in patients that are known to have rearrangement (mutation) in the ALK, ROS or NTRK 1-3 genes.
Repotrectinib is a type of drug called a tyrosine kinase inhibitor (TKI). A tyrosine kinase inhibitor is a drug that inhibits enzymes called receptor tyrosine kinases (RTKs). RTKs function as an "on" or "off" switch in many cellular functions.
Scientific advances have found that RTKs can lead to the development of non-small-cell-lung cancer (NSCLC) where a specific gene called the anaplastic lymphoma kinase (ALK) gene is rearranged (has a mutation). This serves as a typical example for the management of gene mutations that are responsible for both the initiation and maintenance of cancer.The UK will not take part in the phase 1 part of the study. The phase 1 part was to look at the response of tumours to different doses of repotrectinib, side effects and how different foods affect how repotrectinib gets into the body.
The Phase 2 part of the study will continue to look at the side effects, as well as how repotrectinib is absorbed in the body in groups of patients who have the various tumour gene mutations mentioned above. The study will include approximately 320 patients between six treatment groups based on the patient’s gene mutation and previous cancer treatment.The average participation in the study is likely to be 4 to 10 months. However, participation may be longer or shorter.
REC name
London - Fulham Research Ethics Committee
REC reference
19/LO/1694
Date of REC Opinion
10 Dec 2019
REC opinion
Further Information Favourable Opinion