Study of INCB123667 in Subjects With Advanced Solid Tumors
ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIncyte Corporation
About this trial
This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy and in combination with anticancer therapies in participants with selected advanced or metastatic solid tumors. This study will consist of 2 parts. In Part 1, INCB123667 will be administered as monotherapy and in Part 2, INCB123667 will be administered in combination with anticancer therapies of interest. Each part will comprise a dose escalation portion (Parts 1a and 2a, respectively) and a dose-expansion portion (Parts 1b and 2b, respectively).
Eligibility criteria
Qualifiers
Adults aged 18 years or older at the time of the signing of the ICF.
Life expectancy greater than 12 weeks.
ECOG performance status score of 0 or 1.
Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available treatment to improve the disease outcome.
Disqualifiers
History of clinically significant or uncontrolled cardiac disease.
History or presence of an ECG abnormality that, in the investigator's opinion, is clinically meaningful.
Presence of chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed.
Trial design
Treatments tested in this trial
- INCB0123667
- Palbociclib
- Bevacizumab
- Olaparib
- Paclitaxel
- Ribociclib
- Fulvestrant
Treatment groups
604 Participants
are divided into 21 treatment groups21
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov