A Phase 1-2 Study of Ti-061 in Patients with Advanced Malignancies
Research type
Research Study
Full title
A Phase 1-2 Study of Ti-061 Alone and in Combination with other Anti-cancer Agents in Patients with Advanced Malignancies
IRAS ID
217246
Contact name
David Hinds
Contact email
Sponsor organisation
Tioma Therapeutics, Inc.
Eudract number
2016-004372-22
Duration of Study in the UK
0 years, 34 months, 0 days
Research summary
A Phase 1-2 Study of Ti-061 alone, and in combination with other anti-cancer agents, in adult patients with advanced malignancies (cancer that has come back or spread). The study will look at the safety and tolerability of the study drug Ti-061. It will examine what happens to the study drug in the body and its effect on tumours, and whether the study drug activates patient immune systems.
Ti-061 is a type of drug called a checkpoint inhibitor and works against a protein called CD47 that is widely found on cancer cells. CD47 protects cancer cells by giving out a “don’t eat me” signal to the immune system. We believe Ti-061 may help to turn the immune system against cancer cells that express CD47.
Part A of the study will use different doses of Ti-061 to identify the best dose to be given to patients (escalation stage). This will involve up to 36 patients. After an assessment of safety and tolerability, the study will include an additional 64-120 patients, who will be treated using the optimal dose of study drug as identified in the first stage. Patients will be enrolled into groups depending on whether they have breast, ovarian, gastroesophageal or colorectal cancer. These cancers have high expression of CD47.
Part B of the study will look at the study drug given with pembrolizumab. The dose escalation phase will involve up to 36 patients and after assessments of safety and tolerability, will include an additional 64-120 patients with breast, liver, bladder, or lung cancer.
Ti-061 will be given as an intravenous (IV) infusion through a needle inserted into a vein in the arm either weekly or fortnightly.The study will last 34 months in approximately 6-8 hospital sites in Europe and the US.
REC name
West of Scotland REC 1
REC reference
17/WS/0046
Date of REC Opinion
5 Apr 2017
REC opinion
Further Information Favourable Opinion