Study of GS-4528 for Adults With Solid Tumours
Research type
Research Study
Full title
A Phase 1 Study to Evaluate the Safety and Tolerability of GS-4528 as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors
IRAS ID
1006962
Contact name
Estibaliz Lopez Rodrigo
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Clinicaltrials.gov Identifier
Research summary
The goals of this study are to identify if the experimental drug GS-4528, alone or in combination with Anti-PD-1 Monoclonal Antibody, is safe and tolerable in people with solid tumours and to identify the recommended dose of GS-4528 for further development that is safe to give to people alone or in combination with Anti-PD-1 Monoclonal Antibody.
This study has three phases. On Phase 1a dose escalation, GS-4528 will be administered alone to eligible patients with any type of solid tumour at different escalating doses in order to determine the highest dose of GS-4528 that is safe and tolerated. Once this dose is determined, in Phase 1a dose expansion GS-4528 will be administered alone at the determined dose to patients with selected indications. In Phase 1b dose escalation patients will receive escalating doses of GS-4528 in combination with anti-PD1 monoclonal antibody to determine the maximum tolerated dose of GS-4528 as a combination therapy.
Patients who meet all eligibility criteria will be assigned to a treatment group which will be determined by when they join the study and they will know what study drug(s) they will be receiving.
Prior to the start of treatment patients will undergo screening assessments. During the treatment period, patients may have the following assessments: physical examinations, vital signs, electrocardiograms, blood and urine sample collection for testing, computed tomography or magnetic resonance imaging scans, and fresh tumour biopsy. The length of treatment will depend on how well the patient tolerates the study treatment and the response of their tumour. Patients will be followed monthly up to 90 days beyond end of treatment. Patients can discontinue their participation in the study any time.
Approximately 132 adult participants will participate worldwide with approximately 13 patients from 2 hospitals in the UK. The Sponsor of this study is Gilead Sciences, Inc.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
23/LO/0087
Date of REC Opinion
30 May 2023
REC opinion
Further Information Favourable Opinion