A Phase 1 study to evaluate IK-930 in subjects with advanced solid tumors
Research type
Research Study
Full title
A Phase 1, First in Human Study of IK-930, an Oral TEAD Inhibitor Targeting the Hippo Pathway in Subjects with Advanced Solid Tumors
IRAS ID
1006211
Contact name
Isabel Paxton
Contact email
Sponsor organisation
Ikena Oncology, Inc.
Eudract number
2022-002308-20
Clinicaltrials.gov Identifier
Research summary
Cancer is one of the leading causes of death worldwide. Many cancer indications have a poor prognosis, and the management of most advanced solid tumours remains challenging due to the high rate of tumour recurrence or the development of distant secondary growths. IK-930 is an investigational product for the treatment of advanced solid tumours and will be administered orally. The study sponsor of this phase 1 (first in human) study is Ikena Oncology Inc.
Approximately 158 men and women aged >18 years with an advanced solid tumour will be enrolled globally. The study has a Dose Escalation phase followed by a Dose Expansion phase. Approximately 50 subjects will be enrolled for the Dose Escalation phase and approximately 108 subjects will be enrolled for the Dose Expansion phase. During the Dose Escalation phase, a separate cohort of subjects will be enrolled to conduct a pilot study to evaluate the effects of food and lansoprazole on the pharmacokinetics of IK-930. In the Dose Escalation phase at least 3 subjects will be enrolled in each dose level cohort, with 9 dose escalation levels planned. The Dose Expansion phase will assess the antitumour activity of IK-930 within 4 histologically and/or genetically defined cohorts of solid tumours. The dose and schedule of IK-930 administration in this phase will be determined based on the data available at the end of the Dose Escalation phase.
Patients will be in the study for up to approximately 13 months and will attend multiple planned visits. The study is made up of the following periods: Screening Period of up to 28 days prior to starting the Treatment Period, IK-930 treatment cycles as monotherapy repeated every 3 or 4 weeks, End of Treatment 30-day Follow-up visit, and End of Trial 90-day Follow-up/End of Study visit. Study procedures include but are not limited to physical examination, vital signs, blood samples, ECG, LVEF %, scans using either CT, MRI or X-Ray, tumour biopsy and pleural effusion.
REC name
London - Hampstead Research Ethics Committee
REC reference
23/LO/0301
Date of REC Opinion
30 May 2023
REC opinion
Further Information Favourable Opinion