A Phase I/II trial of intralesional administration of RGT100
Research type
Research Study
Full title
A Phase I/II, Multicenter, Open-label, Clinical Trial of Intratumoral/Intralesional Administration of RGT100 in Subjects with Advanced or Recurrent Tumors
IRAS ID
215976
Contact name
Mark Middleton
Contact email
Sponsor organisation
Rigontec GmbH
Eudract number
2016-003028-22
Duration of Study in the UK
2 years, 1 months, days
Research summary
This is a Phase 1/2 multicenter, first-in-human, open-label, dose escalation study which will evaluate the safety, tolerability, and anti-cancer activity of intratumoral/intralesional injections of RGT100-PEI in participants with selected advanced or recurrent tumors.
The study drug RGT100-PEI might be able to bind to the Cytosolic receptor and activates the cytosolic receptor RIG-I that might be able to stop the cancer cells from growing.
This study will be conducted in 2 groups (Group A and Group B) and has 2 phases (Dose Escalation Phase and Expansion Phase). The participants will participate in only 1 Group (which will be determined by the location of their cancer) and in only 1 Phase of the study.The participants will be assigned to Group A if they have a transdermal/transmucosal (i.e. cutaneous) cancer. The participation in this study will last up to 90 days (4 weeks treatment period and up to 2 month follow-up period) and include 12 study visits at the study site.
If the participants are eligible to be part of the study, they will be assigned to Group B if they have liver cancer or metastases. The participation in this study will last up to 90 days (4 week treatment period and up to 2 month follow-up period) and includes 8 study visits at the research centre.
Once the participants have successfully completed the treatment period of the study they might be eligible to be offered extended treatment with a second cycle of RGT100-PEI for an additional 4 weeks.
The study will be conducted at 1 site in UK.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
16/SC/0547
Date of REC Opinion
6 Dec 2016
REC opinion
Further Information Favourable Opinion