Study of INCB123667 in Subjects With Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study summary
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
Primary outcome measure(s)
- Part 1A : Occurrence of Dose Limiting Toxicities (DLTs) — Up to Day 28
Toxicities occurring during the first treatment cycle, Part 1a, will define tolerability. DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria. - Number of Participants With Treatment Emergent Adverse Events (TEAEs) — Up to 12 months
TEAE is any Adverse Event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug. - Number of Participants with Dose Interruptions due to TEAE — Up to 12 months
Participants will receive dose reductions of INCB123667 according to lab guidelines. Treatment may be delayed for up to 2 weeks to allow for resolution of toxicity. - Number of Participants who Undergo Dose Reductions due to TEAE — Up to 12 months
Participants will receive dose reductions according to lab guidelines. Treatment may be delayed for up to 2 weeks to allow for resolution of toxicity. - Number of Participants Discontinue study due to TEAE — Up to 12 months
TEAE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Trial sites (41)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope Medical Center | Duarte | California | |
| City of Hope-Lennar Foundation Cancer Center | Irvine | California | |
| Valkyrie Clinical Trials | Los Angeles | California | |
| Rocky Mountain Cancer Centers-Sky Ridge | Lone Tree | Colorado | |
| Yale Cancer Center | New Haven | Connecticut | |
| Mount Sinai Medical Center Comprehensive Cancer Center | Miami Beach | Florida | |
| Emory University | Atlanta | Georgia | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| New York Presbyterian/Weill Cornell | New York | New York | |
| Ny Cancer and Blood Specialists | Shirley | New York | |
| Carolina Bio-Oncology Institute, Pllc | Huntersville | North Carolina | |
| University of Pennsylvania Abramson Cancer Center | Philadelphia | Pennsylvania | |
| University of Pittsburgh Cancer Institute Cancer Services | Pittsburgh | Pennsylvania | |
| Allegheny Health Network | Pittsburgh | Pennsylvania | |
| Tennessee Oncology | Nashville | Tennessee | |
| Texas Oncology-Fort Worth South Henderson | Fort Worth | Texas | |
| Virginia Cancer Institute | Fairfax | Virginia | |
| University of Wisconsin | Madison | Wisconsin | |
| Institut Bergonie | Bordeaux | France | |
| Centre Leon Berard | Lyon | 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-ken | 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 |
+ 1 more sites — see the full list on the official registry below.
On this site
📄 Ibrance (palbociclib) drug profile → 📄 Avastin (bevacizumab) drug profile → 📄 Lynparza (olaparib) drug profile → 📄 Kisqali (ribociclib) drug profile →More Incyte Corporation trials in Japan
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05238922 on ClinicalTrials.gov ↗ ← All trials in Japan