EIK1003-001: A first-in-human study of IMP1734, in patients with advanced solid tumors
Research type
Research Study
Full title
A first-in-human, Phase 1/2, open-label, multi-center, dose-escalation, dose optimization, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of PARP1 selective inhibitor, IMP1734, in patients with advanced solid tumors
IRAS ID
1009109
Contact name
Caroline Taromino
Contact email
Sponsor organisation
Eikon Therapeutics, Inc.
Eudract number
2023-509230-19
Research summary
Eikon Therapeutics (the Sponsor) are running a first-in-human, Phase 1/2, open-label, multi-center, dose-escalation, dose-optimization, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of PARP1 selective inhibitor, IMP1734, in patients with advanced solid tumors.
The study will be conducted in three parts, part 1 (dose escalation), part 2 (dose optimisation) and part 3 (dose expansion). Part 1 will include approximately 70 participants who will be split into 2 groups, the single-dose period group and the multi-dose period group. The single-dose period group will receive the first dose of IMP1734 followed by a certain amount of days (5 days) in which you receive no study medication. Once this period of time passes, the participants will take the study medication every day. Some participants may enter directly in the multi-dose period group and begin taking the study medication every day as instructed by the study doctor.
Participants must provide written consent prior to undergoing study procedures. After Screening assessments, eligible participants will be assigned to one of the treatment groups. Both treatment groups will receive the study treatment in 21-day (3 week) cycles. Participants will receive the study medication in tablet form which you will take orally (by mouth) daily. Study participants will visit the study site at the time points specified in the ICF, where they will be asked about medical history and general health. Participants will undergo procedures such as, a tumour biopsy, blood and urine tests, ECGs, and a physical examination including weight and height measurements as well as tumour imaging.
The Safety Monitoring Committee (SMC) will be set up separately to review the safety, efficacy, PK, and/or PD data for Part 1, Part 2, and Part 3 of the study and reviews will be carried out at established timepoints.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
24/SC/0234
Date of REC Opinion
10 Oct 2024
REC opinion
Further Information Unfavourable Opinion