Actively Recruiting
Study of INCB123667 in Subjects With Advanced Solid Tumors
Led by Incyte Corporation · Updated on 2026-04-14
604
Participants Needed
42
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study of INCB123667 in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older at the time of signing consent
- Life expectancy greater than 12 weeks
- ECOG performance status score of 0 or 1
- Disease progressed on prior standard treatment, intolerant to or ineligible for standard treatment, or no treatment available to improve outcome
- Availability of baseline tumor specimen or willingness to undergo pre- and on-treatment tumor biopsies
- Histologically or cytologically confirmed advanced or metastatic solid tumors for dose escalation parts
- Specific tumor groups for dose expansion parts including ovarian/fallopian/primary peritoneal cancer, endometrial/uterine cancer, gastric, GEJ, esophageal carcinomas, TNBC, HR+/HER2- breast cancer, and other tumors excluding bone cancers
- Measurable lesions by CT or MRI based on RECIST v1.1 criteria for Part 2 dose expansion
You will not qualify if you...
- Clinically significant or uncontrolled cardiac disease
- ECG abnormalities deemed clinically meaningful by investigator
- Chronic or active infections requiring systemic treatment
- Untreated or progressing brain or CNS metastases
- Additional progressing malignancy or other malignancy within 2 years requiring active treatment
- Specific abnormal laboratory values (not detailed here)
- Significant uncontrolled medical conditions including hepatic and gastrointestinal
- Not recovered to Grade 1 or better from prior therapy toxic effects or surgical complications before starting study drug
- Prior treatment with any CDK2 inhibitor
- Recent changes in endocrine therapy or administration of targeted, antibody, or hypomethylating agents within defined timeframes before study drug
- Major surgery within 28 days before study drug
- Radiation therapy within 28 days before study drug
- Treatment with another investigational medication within defined timeframes before study drug
- Active hepatitis B or C infection requiring treatment
- Known HIV infection
- Known hypersensitivity or severe reactions to study treatments or components
- Other protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 42 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope-Lennar Foundation Cancer Center
Irvine, California, United States, 92618
Actively Recruiting
3
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
4
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States, 80124
Actively Recruiting
5
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Completed
6
Mount Sinai Medical Center Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Actively Recruiting
7
Emory University
Atlanta, Georgia, United States, 30322
Completed
8
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10022
Completed
9
New York Presbyterian/Weill Cornell
New York, New York, United States, 10065
Completed
10
Ny Cancer and Blood Specialists
Shirley, New York, United States, 11967
Not Yet Recruiting
11
Carolina Bio-Oncology Institute, Pllc
Huntersville, North Carolina, United States, 28078
Completed
12
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Withdrawn
13
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
14
University of Pittsburgh Cancer Institute Cancer Services
Pittsburgh, Pennsylvania, United States, 15213
Completed
15
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15224
Not Yet Recruiting
16
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
17
Texas Oncology-Fort Worth South Henderson
Fort Worth, Texas, United States, 76104
Completed
18
Virginia Cancer Institute
Fairfax, Virginia, United States, 22031
Actively Recruiting
19
University of Wisconsin
Madison, Wisconsin, United States, 53792
Not Yet Recruiting
20
Institut Bergonie
Bordeaux, France, 33076
Actively Recruiting
21
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
22
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole
Toulouse, France, 31059
Actively Recruiting
23
Institut Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
24
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, Italy, 20133
Actively Recruiting
25
Istituto Nazionale Tumori Irccs Fondazione Pascale
Naples, Italy, 80131
Completed
26
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Rome, Italy, 00168
Actively Recruiting
27
Irccs Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
28
Centro Ricerche Cliniche Di Verona
Verona, Italy, 37134
Actively Recruiting
29
Aichi Cancer Center Hospital
Aichi, Japan, 464 8681
Actively Recruiting
30
National Cancer Center Hospital East
Chiba-ken, Japan, 277-0882
Actively Recruiting
31
Saitama Medical University International Medical Center
Hidaka-shi, Japan, 350-1298
Actively Recruiting
32
National Cancer Center Hospital
Tokyo, Japan, 104-0045
Actively Recruiting
33
The Cancer Institute Hospital of Jfcr
Tokyo, Japan, 135-0063
Actively Recruiting
34
Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
35
Erasmus Medical Center
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
36
Panoncology Trials Pan American Center For Oncology Trials, Llc
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
37
Oncological Institute of Southern Switzerland
Bellinzona, Switzerland, 06500
Actively Recruiting
38
Inselspital Universitatsklinik Fur Medizinische Onkologie
Bern, Switzerland, CH-3010
Actively Recruiting
39
Centre Hospitalier Universitaire Vaudois (Chuv)
Lausanne, Switzerland, 01011
Actively Recruiting
40
Guys Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
41
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London, United Kingdom, W12 0HS
Actively Recruiting
42
Northern Centre For Cancer Care
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
Research Team
I
Incyte Corporation Call Center (US)
CONTACT
I
Incyte Corporation Call Center (ex-US)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
21
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