FONTANA
Research type
Research Study
Full title
A Modular Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Ascending Doses of AZD5335 Monotherapy and in Combination with Anti-cancer Agents in Participants with Solid Tumors
IRAS ID
1008459
Contact name
Sabine Lindner
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for a better way to treat solid tumours. In people with cancer, the body is unable to control the growth of some cells and they can form tumours. Solid tumours form in solid organs of the body, and some types of solid tumours have high levels of a
protein called FR-alpha. The trial drug, AZD5335, is designed to find and kill cancer cells with high levels of FR-alpha. This trial has 2 modules, and more modules may be added later.
Participants in Module 1 will have ovarian cancer or a type of lung cancer called lung adenocarcinoma (LUAC), and receive AZD5335 alone. Participants in Module 2 will have ovarian cancer, and will receive AZD5335 with an anti-cancer drug called AZD5305.
Participants will receive their trial treatment in cycles of 3 weeks.
All modules will have at least 2 parts. In Part A, researchers will increase the dose of AZD5335 by a small amount for each group of participants (dose escalation) until they find the best doses for Part B. In Part B, researchers will continue looking at these doses of
AZD5335 (dose optimization) to find the best dose to use in other parts or in future trials.
This is a Phase 1 and Phase 2a, first-in-human, open-label trial. First-in-human means that this trial will be the first time AZD5335 is given to people. Open-label means the participants, researchers, trial doctors and staff will know what each participant is receiving. Participants
will receive treatment until it is no longer helping them, or they leave the trial for another reason.
Throughout the trial, to monitor participants’ health, the doctors will test blood and urine, perform physical exams, check vital signs, take CT and/or MRI scans, take tumour biopsies and test heart function using an electrocardiogram (ECG).REC name
London - Hampstead Research Ethics Committee
REC reference
24/LO/0047
Date of REC Opinion
27 Feb 2024
REC opinion
Further Information Favourable Opinion