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ACTIVE NOT RECRUITINGPhase1

Study of INCB123667 in Subjects With Advanced Solid Tumors

Sponsor: Incyte Corporation

NCT ID: NCT05238922

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
INCB0123667 (drug), Palbociclib (drug), Bevacizumab (drug), Olaparib (drug)
How long the study runs
Study runs about 61 months (dates as stated)
About the drug or intervention
INCB0123667 — drug: 25 mg tablets · Palbociclib — drug: Palbociclib will be administered at protocol defined dose. · Bevacizumab — drug: Bevacizumab will be administered at protocol defined dose. · Olaparib — drug: Olaparib will be administered at protocol defined dose. · Paclitaxel — drug: Paclitaxel will be administered at protocol defined dose. · Ribociclib — drug: Ribociclib will be administered at protocol defined dose. · Fulvestrant — drug: Fulvestrant will be administered at protocol defined dose.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
291
Started
2022-07-05
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for solid tumors
  • • Phase1 - 291 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with solid tumors

Where?

  • • London - Guys Hospital
  • • London - Imperial College Healthcare Nhs Trust - Hammersmith Hospital
  • • Newcastle upon Tyne - Northern Centre For Cancer Care

This is a simplified summary. Always discuss with your doctor before making any decisions.

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).

Solid Tumors

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

HER2

What the study is looking for

  • ✓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...
  • ✓Availability of a baseline archival tumor specimen or willingness to undergo a pretreatment and an on-treatment...

Who cannot take part

  • ✗History of clinically significant or uncontrolled heart 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...
  • ✗Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed.
  • ✗Known additional cancer that is progressing or requires active treatment, or history of other cancer within...
See the full criteria
Inclusion Criteria: * 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. * 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 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. * 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. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Where Is This Study? (3 UK sites)

Guys Hospital

London SE1 9RT, United Kingdom

Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Imperial College Healthcare Nhs Trust - Hammersmith Hospital

London W12 0HS, United Kingdom

Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

Northern Centre For Cancer Care

Newcastle upon Tyne NE7 7DN, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-07