Study of INCB123667 in Subjects With Advanced Solid Tumors
NCT ID: NCT05238922
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
604 participants
INTERVENTIONAL
2022-07-05
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 2b Dose Expansion Treatment Group M (TGM)
INCB123667 administered in combination with olaparib at the recommended doses in participants with gynecologic tumors (epithelial ovarian/fallopian/primary peritoneal carcinoma) as defined by the protocol.
INCB0123667
25 mg tablets
Olaparib
Olaparib will be administered at protocol defined dose.
Phase 1a Dose Escalation
INCB123667 will be administered at a protocol defined starting regimen once daily (QD) orally in 28-day cycles.
Subsequent dose regimens will be determined during study conduct.
INCB0123667
25 mg tablets
Phase 1b: Dose Expansion Cohort Disease Group 1
INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with gynecologic tumors (epithelial ovarian/fallopian/primary peritoneal carcinoma) will enroll in this group.
INCB0123667
25 mg tablets
Phase 1b: Dose Expansion Cohort Disease Group 2
INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with Endometrial/Uterine cancer will enroll in this group.
INCB0123667
25 mg tablets
Phase 1b: Dose Expansion Cohort Disease Group 3
INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with gastric, Gastro Esophageal Junction (GEJ), and esophageal adenocarcinomas will enroll in this group.
INCB0123667
25 mg tablets
Phase 1b: Dose Expansion Cohort Disease Group 4
INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with Triple Negative Breast Cancer(TNBC) will enroll in this group.
INCB0123667
25 mg tablets
Phase 1b: Dose Expansion Cohort Disease Group 5
INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with HR+/HER2- breast cancer who have had disease progression on or been intolerant of a CDK4/6 inhibitor will enroll in this group.
INCB0123667
25 mg tablets
Phase 1b: Dose Expansion Cohort Disease Group 6
INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors will enroll in this group.
INCB0123667
25 mg tablets
Phase 2a Dose Escalation Treatment Group A (TGA)
INCB123667 administered in combination with palbociclib at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol.
INCB0123667
25 mg tablets
Palbociclib
Palbociclib will be administered at protocol defined dose.
Phase 2a Dose Escalation Treatment Group B (TGB)
INCB123667 administered in combination with palbociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol.
INCB0123667
25 mg tablets
Palbociclib
Palbociclib will be administered at protocol defined dose.
Fulvestrant
Fulvestrant will be administered at protocol defined dose.
Phase 2a Dose Escalation Treatment Group C (TGC)
INCB123667 administered in combination with ribociclib at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol.
INCB0123667
25 mg tablets
Ribociclib
Ribociclib will be administered at protocol defined dose.
Phase 2a Dose Escalation Treatment Group D (TGD)
INCB123667 administered in combination with ribociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol.
INCB0123667
25 mg tablets
Ribociclib
Ribociclib will be administered at protocol defined dose.
Fulvestrant
Fulvestrant will be administered at protocol defined dose.
Phase 2a Dose Escalation Treatment Group E (TGE)
INCB123667 administered in combination with bevacizumab at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol.
INCB0123667
25 mg tablets
Bevacizumab
Bevacizumab will be administered at protocol defined dose.
Phase 2a Dose Escalation Treatment Group F (TGF)
INCB123667 administered in combination with olaparib at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol.
INCB0123667
25 mg tablets
Olaparib
Olaparib will be administered at protocol defined dose.
Phase 2a Dose Escalation Treatment Group G (TGG)
INCB123667 administered in combination with paclitaxel at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol.
INCB0123667
25 mg tablets
Paclitaxel
Paclitaxel will be administered at protocol defined dose.
Phase 2b Dose Expansion Treatment Group H (TGH)
INCB123667 administered in combination with palbociclib at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol.
INCB0123667
25 mg tablets
Palbociclib
Palbociclib will be administered at protocol defined dose.
Phase 2b Dose Expansion Treatment Group I (TGI)
INCB123667 administered in combination with palbociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol
INCB0123667
25 mg tablets
Palbociclib
Palbociclib will be administered at protocol defined dose.
Fulvestrant
Fulvestrant will be administered at protocol defined dose.
Phase 2b Dose Expansion Treatment Group J (TGJ)
INCB123667 administered in combination with ribociclib at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol.
INCB0123667
25 mg tablets
Ribociclib
Ribociclib will be administered at protocol defined dose.
Phase 2b Dose Expansion Treatment Group K (TGK)
INCB123667 administered in combination with ribociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol.
INCB0123667
25 mg tablets
Ribociclib
Ribociclib will be administered at protocol defined dose.
Fulvestrant
Fulvestrant will be administered at protocol defined dose.
Phase 2b Dose Expansion Treatment Group L (TGL)
INCB123667 administered in combination with bevacizumab at the recommended doses in participants with gynecologic tumors (epithelial ovarian/fallopian/primary peritoneal carcinoma) as defined by the protocol.
INCB0123667
25 mg tablets
Bevacizumab
Bevacizumab will be administered at protocol defined dose.
Phase 2b Dose Expansion Treatment Group N (TGN)
INCB123667 administered in combination with weekly paclitaxel at the recommended doses in participants with gynecologic tumors (epithelial ovarian/fallopian/primary peritoneal carcinoma) as defined by the protocol.
INCB0123667
25 mg tablets
Paclitaxel
Paclitaxel will be administered at protocol defined dose.
Interventions
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INCB0123667
25 mg tablets
Palbociclib
Palbociclib will be administered at protocol defined dose.
Bevacizumab
Bevacizumab will be administered at protocol defined dose.
Olaparib
Olaparib will be administered at protocol defined dose.
Paclitaxel
Paclitaxel will be administered at protocol defined dose.
Ribociclib
Ribociclib will be administered at protocol defined dose.
Fulvestrant
Fulvestrant will be administered at protocol defined dose.
Eligibility Criteria
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Inclusion Criteria
* 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.
* Availability of a baseline archival tumor specimen or willingness to undergo a pretreatment and an on-treatment tumor biopsy.
For Part 1:
Participants in Part 1A (dose escalation): Histologically or cytologically confirmed advanced or metastatic solid tumors.
Participants in Part 1B (dose expansion):
* Disease Group 1: Ovarian/Fallopian/Primary Peritoneal Cancer
* Disease Group 2: Endometrial/Uterine Cancer
* Disease Group 3: Gastric, GEJ, and esophageal carcinomas
* Disease Group 4: TNBC
* Disease Group 5: HR+/HER2- breast cancer
* Disease Group 6: Other tumor indications excluding bone cancers
For Part 2:
Participants in Part 2A (dose escalation): Histologically or cytologically confirmed advanced or metastatic solid tumors.
* TGA, TGC, TGE, TGF, and TGG: Participants with HR+/HER2- breast cancer or participants with a different tumor.
* TGB and TGD: Participants with HR+/HER2- breast cancer.
Participants in Part 2b (dose expansion):
* TGH and TGJ:
* Participants with HR+/HER2- breast cancer.
* Participants with any other advanced or metastatic solid tumor.
* TGI and TGK:
• Participants with HR+/HER2- breast cancer.
* TGL, TGM and TGN:
• Participants with advanced or metastatic epithelial ovarian/fallopian/primary peritoneal carcinoma.
* Measurable lesions by CT or MRI based on RECIST v1.1 criteria.
Exclusion Criteria
* 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.
* Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of the first dose of study drug.
* Specific laboratory values.
* Significant concurrent, uncontrolled medical conditions, including but not limited to Hepatic and Gastrointestinal.
* Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study drug.
* Prior treatment with any CDK2 inhibitor.
* Any change in endocrine therapy within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug or any administration of targeted therapy, antibody, or hypomethylating agent to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug.
* Any major surgery within 28 days before the first dose of study drug.
* Any prior radiation therapy within 28 days before the first dose of study drug.
* Undergoing treatment with another investigational medication or having been treated with an investigational medication within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug.
* Active HBV or HCV infection that requires treatment.
* Known history of HIV.
* Known hypersensitivity or severe reaction to any component of study treatment or formulation components.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Liz Croft, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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City of Hope Medical Center
Duarte, California, United States
City of Hope-Lennar Foundation Cancer Center
Irvine, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Mount Sinai Medical Center Comprehensive Cancer Center
Miami Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
New York Presbyterian/Weill Cornell
New York, New York, United States
Ny Cancer and Blood Specialists
Shirley, New York, United States
Carolina Bio-Oncology Institute, Pllc
Huntersville, North Carolina, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute Cancer Services
Pittsburgh, Pennsylvania, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Tennessee Oncology
Nashville, Tennessee, United States
Texas Oncology
Austin, Texas, United States
Texas Oncology-Fort Worth South Henderson
Fort Worth, Texas, United States
Virginia Cancer Institute
Fairfax, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Institut Bergonie
Bordeaux, , France
Centre Leon Berard
Lyon, , France
Institut Curie
Paris, , France
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, , Italy
Istituto Nazionale Tumori Irccs Fondazione Pascale
Naples, , Italy
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Rome, , Italy
Irccs Istituto Clinico Humanitas
Rozzano, , Italy
Centro Ricerche Cliniche Di Verona
Verona, , Italy
Aichi Cancer Center Hospital
Aichi, , Japan
National Cancer Center Hospital East
Chiba, , Japan
Saitama Medical University International Medical Center
Hidaka-shi, , Japan
National Cancer Center Hospital
Tokyo, , Japan
The Cancer Institute Hospital of Jfcr
Tokyo, , Japan
Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Panoncology Trials Pan American Center For Oncology Trials, Llc
Rio Piedras, , Puerto Rico
Oncological Institute of Southern Switzerland
Bellinzona, , Switzerland
Inselspital Universitatsklinik Fur Medizinische Onkologie
Bern, , Switzerland
Centre Hospitalier Universitaire Vaudois (Chuv)
Lausanne, , Switzerland
Guys Hospital
London, , United Kingdom
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London, , United Kingdom
The Christie Nhs Foundation Trust Uk
Manchester, , United Kingdom
Northern Centre For Cancer Care
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Related Links
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Study of INCB123667 in Subjects with Advanced Solid Tumors
Other Identifiers
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2021-005357-91
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 123667-101
Identifier Type: -
Identifier Source: org_study_id