* WP42627: RO7300490 +/- ATEZOLIZUMAB IN SOLID TUMORS
Research type
Research Study
Full title
AN OPEN-LABEL, MULTICENTER, DOSE-ESCALATION AND EXPANSION, PHASE I STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND ANTI-TUMOR ACTIVITY OF RO7300490, A FIBROBLAST ACTIVATION PROTEIN-α (FAP) TARGETED CD40 AGONIST, AS SINGLE AGENT OR IN COMBINATION WITH ATEZOLIZUMAB IN PARTICIPANTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS
IRAS ID
295949
Contact name
Fiona Thistlethwaite
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2020-004489-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 11 months, 4 days
Research summary
The participants in this immunotherapy clinical trial have an advanced or metastatic solid tumour, which did not respond to their current treatment or returned following their last treatment.
The purpose of this study is to test the safety of RO7300490 at different dose levels, alone or in combination with a fixed dose of the anti-cancer drug atezolizumab (Tecentriq™), and to find out what effects, good or bad, RO7300490, alone or in combination with atezolizumab, has on an advanced or metastatic solid tumours.
RO7300490 belongs to a group of medicines called cancer immunotherapeutics. It is designed to activate the immune system to fight the cancer cells. More precisely, RO7300490 is a protein with two functional units, which work together as follows:
• The first unit is able to interact with a protein called fibroblast activation protein α (FAP), which is found in most solid tumours. This interaction enables RO7300490 to go to the tumour and stay there.
• The second unit interacts with protein called CD40, which is found on cells of the body’s immune system. These cells are also present in the tumour. When RO7300490 simultaneously interacts with CD40 and FAP, the immune cells receive a signal to initiate tumour cell killing.
However, tumour cells can adapt and resist to the attack from the body’s immune system by producing a protein called programmed death-ligand 1 (PD-L1). PD-L1 helps tumour cells to resist the attack. The drug atezolizumab blocks PD-L1 and may therefore prevent cancer cells from resisting the attack from the activated cells of the immune system.
RO7300490 is an experimental cancer immunotherapeutic drug, which means Health Authorities have not approved it for the treatment of solid tumours. This will be the first time that RO7300490 will be given to humans.
Atezolizumab (Tecentriq™) is an approved cancer immunotherapy drug that is used to treat several types of cancers. However, its use in combination with RO7300490 is experimental, which means that the Health Authorities have not approved atezolizumab as a combination drug with RO7300490 for the treatment of solid tumours.The study will consist of three parts: Part 1, Part 2, and Part 3:
• Part 1: Participants will receive RO7300490 only.
• Part 2 and Part 3: Participants will receive RO7300490 in combination with atezolizumab.Approximately, 60 participants will take part globally in Part 1 (approximately 24 participants from 3 UK hospitals).
The maximum duration for each participant in Part 1 will be 2 years, excluding survival follow-up.The study is sponsored by F. Hoffman La Roche.
Final Report
https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fforpatients.roche.com%252Fen%252Ftrials%252Fcancer%252Fsolid-tumors%252Fa-study-to-evaluate-safety--pharmacokinetics-and-anti-t-88927.html%2FNBTI%2FGSi7AQ%2FAQ%2F3a0f3595-2d82-4c2c-a369-0260317dc928%2F1%2Fj2RwNyeU6f&data=05%7C02%7Cgmwest.rec%40hra.nhs.uk%7Ca2dca5f7885f4c701fa108dd451ea9dc%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638742720201658363%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Ge94UgoSN5BKONCsvom5ptVyOIOxC1Zs19CdyloWJbU%3D&reserved=0REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
22/NW/0261
Date of REC Opinion
26 Mar 2021
REC opinion
Further Information Favourable Opinion