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New drug INCB123667 enters human trials for Hard-to-Treat cancers

NCT ID NCT05238922

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This early-stage trial is testing a new drug called INCB123667, taken as a tablet, in people with advanced solid tumors that have not responded to standard treatments. The study will first test the drug alone, then in combination with other cancer therapies. The main goals are to check safety, find the right dose, and see early signs of whether the drug can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
INCB123667 (a drug taken as a tablet)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is an early Phase 1 trial focused on safety and dosing, so it is very uncertain whether the drug will work. Side effects are unknown, and the study is not designed to prove effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

291 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast neoplasm carcinoma of esophagus Carcinoma, Ovarian Epithelial Digestive System Neoplasms endometrial cancer fallopian tube cancer gastric carcinoma gastroesophageal junction adenocarcinoma hormone receptor-positive breast cancer metastatic malignant neoplasm neoplasm ovarian cancer primary peritoneal carcinoma triple-negative breast carcinoma uterine cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumors

Contacts and locations

Locations

  • Aichi Cancer Center Hospital

    Aichi, 464 8681, Japan

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15224, United States

  • Carolina Bio-Oncology Institute, Pllc

    Huntersville, North Carolina, 28078, United States

  • Centre Hospitalier Universitaire Vaudois (Chuv)

    Lausanne, 01011, Switzerland

  • Centre Leon Berard

    Lyon, 69008, France

  • Centro Ricerche Cliniche Di Verona

    Verona, 37134, Italy

  • City of Hope Medical Center

    Duarte, California, 91010, United States

  • City of Hope-Lennar Foundation Cancer Center

    Irvine, California, 92618, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Erasmus Medical Center

    Rotterdam, 3015 GD, Netherlands

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan, 20133, Italy

  • Guys Hospital

    London, SE1 9RT, United Kingdom

  • Imperial College Healthcare Nhs Trust - Hammersmith Hospital

    London, W12 0HS, United Kingdom

  • Inselspital Universitatsklinik Fur Medizinische Onkologie

    Bern, CH-3010, Switzerland

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut Gustave Roussy

    Villejuif, 94800, France

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Istituto Nazionale Tumori Irccs Fondazione Pascale

    Naples, 80131, Italy

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10022, United States

  • Mount Sinai Medical Center Comprehensive Cancer Center

    Miami Beach, Florida, 33140, United States

  • National Cancer Center Hospital

    Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Chiba-ken, 277-0882, Japan

  • Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX, Netherlands

  • New York Presbyterian/Weill Cornell

    New York, New York, 10065, United States

  • Northern Centre For Cancer Care

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Ny Cancer and Blood Specialists

    Shirley, New York, 11967, United States

  • Oncological Institute of Southern Switzerland

    Bellinzona, 06500, Switzerland

  • Panoncology Trials Pan American Center For Oncology Trials, Llc

    Rio Piedras, 00935, Puerto Rico

  • Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

    Rome, 00168, Italy

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124, United States

  • Saitama Medical University International Medical Center

    Hidaka-shi, 350-1298, Japan

  • Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Texas Oncology-Fort Worth South Henderson

    Fort Worth, Texas, 76104, United States

  • The Cancer Institute Hospital of Jfcr

    Tokyo, 135-0063, Japan

  • Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

    Toulouse, 31059, France

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Cancer Institute Cancer Services

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067, United States

  • Virginia Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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