A Phase 1 Study of INCB123667 as Monotherapy in Participants With Selected Advanced Solid Tumours
Research type
Research Study
Full title
A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy in Participants With Selected Advanced Solid Tumors
IRAS ID
1004219
Contact name
Michael McGraw
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2021-005357-91
Clinicaltrials.gov Identifier
Research summary
This is a Phase 1, multicenter, open-label, dose-escalation, and dose-expansion clinical study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of INCB123667 when given as monotherapy in participants with selected advanced or metastatic solid tumours.
Part 1a will consist of dose escalation to assess the safety and tolerability and to identify the maximum tolerated dose and/or recommended dose for expansion, pharmacokinetic, and preliminary antitumor activity of INCB123667 administered as monotherapy. This phase will include approximately 40 evaluable participants with any advanced or metastatic solid tumours that have progressed on prior standard treatment or who are intolerant to or ineligible for standard treatment or there is no available treatment to improve the participant's disease outcome.
The starting dose of INCB 123667 will be 50 mg once daily administered in 28-day continuous treatment cycles. Intermediate/alternative dose levels or administration schedules (such as once daily, twice daily, or intermittent dosing) may be explored.
Part 1b will include dose expansion to better characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of INCB123667 administered as monotherapy at the recommended dose for expansion defined in Part 1a in approximately 115 participants.
REC name
London - City & East Research Ethics Committee
REC reference
22/LO/0480
Date of REC Opinion
8 Aug 2022
REC opinion
Further Information Favourable Opinion