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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005357-91 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a Dose Escalation | Experimental | 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. |
|
| Phase 1b: Dose Expansion Cohort Disease Group 1 | Experimental | 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. |
|
| Phase 1b: Dose Expansion Cohort Disease Group 2 | Experimental | 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. |
|
| Phase 1b: Dose Expansion Cohort Disease Group 3 | Experimental | 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. |
|
| Phase 1b: Dose Expansion Cohort Disease Group 4 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB0123667 | Drug | 25 mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1A : Occurrence of Dose Limiting Toxicities (DLTs) | 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. | Up to Day 28 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 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. | Up to 12 months |
| Number of Participants with Dose Interruptions due to TEAE | 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. | Up to 12 months |
| Number of Participants who Undergo Dose Reductions due to TEAE | Participants will receive dose reductions according to lab guidelines. Treatment may be delayed for up to 2 weeks to allow for resolution of toxicity. | Up to 12 months |
| Number of Participants Discontinue study due to TEAE | 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. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters: Cmax | Defines as the maximum (peak) plasma drug concentration | Cycle 1 Days 1, 2, 8 and 9; Cycle 2 Day 1; Cycles 3 through 9 Day 1 (each cycle is 28 days) |
| PK parameters: tmax | Defined as the time to reach maximum (peak) plasma concentration following drug administration |
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Inclusion Criteria:
For Part 1:
Participants in Part 1A (dose escalation): Histologically or cytologically confirmed advanced or metastatic solid tumors.
Participants in Part 1B (dose expansion):
For Part 2:
Participants in Part 2A (dose escalation): Histologically or cytologically confirmed advanced or metastatic solid tumors.
Participants in Part 2b (dose expansion):
TGH and TGJ:
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:
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Incyte Corporation Call Center (US) | Contact | 1.855.463.3463 | medinfo@incyte.com | |
| Incyte Corporation Call Center (ex-US) | Contact | +800 00027423 | eumedinfo@incyte.com |
| Name | Affiliation | Role |
|---|---|---|
| Liz Croft, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Recruiting | Duarte | California | 91010 | United States | |
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| Label | URL |
|---|---|
| Study of INCB123667 in Subjects with Advanced Solid Tumors | View source |
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Part 1a and 2a will be dose escalation using a statistical hybrid design to identify the RDE(s). Parts 1b and 2b will consist of dose expansion to better characterize the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of INCB123667 as monotherapy or in combination with anticancer therapies.
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| Experimental |
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. |
|
| Phase 1b: Dose Expansion Cohort Disease Group 5 | Experimental | 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. |
|
| Phase 1b: Dose Expansion Cohort Disease Group 6 | Experimental | 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. |
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| Phase 2a Dose Escalation Treatment Group A (TGA) | Experimental | 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. |
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| Phase 2a Dose Escalation Treatment Group B (TGB) | Experimental | INCB123667 administered in combination with palbociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol. |
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| Phase 2a Dose Escalation Treatment Group C (TGC) | Experimental | 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. |
|
| Phase 2a Dose Escalation Treatment Group D (TGD) | Experimental | INCB123667 administered in combination with ribociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol. |
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| Phase 2a Dose Escalation Treatment Group E (TGE) | Experimental | 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. |
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| Phase 2a Dose Escalation Treatment Group F (TGF) | Experimental | 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. |
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| Phase 2a Dose Escalation Treatment Group G (TGG) | Experimental | 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. |
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| Phase 2b Dose Expansion Treatment Group H (TGH) | Experimental | 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. |
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| Phase 2b Dose Expansion Treatment Group I (TGI) | Experimental | INCB123667 administered in combination with palbociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol |
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| Phase 2b Dose Expansion Treatment Group J (TGJ) | Experimental | 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. |
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| Phase 2b Dose Expansion Treatment Group K (TGK) | Experimental | INCB123667 administered in combination with ribociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol. |
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| Phase 2b Dose Expansion Treatment Group L (TGL) | Experimental | 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. |
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| Phase 2b Dose Expansion Treatment Group M (TGM) | Experimental | 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. |
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| Phase 2b Dose Expansion Treatment Group N (TGN) | Experimental | 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. |
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| Palbociclib | Drug | Palbociclib will be administered at protocol defined dose. |
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| Bevacizumab | Drug | Bevacizumab will be administered at protocol defined dose. |
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| Olaparib | Drug | Olaparib will be administered at protocol defined dose. |
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| Paclitaxel | Drug | Paclitaxel will be administered at protocol defined dose. |
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| Ribociclib | Drug | Ribociclib will be administered at protocol defined dose. |
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| Fulvestrant | Drug | Fulvestrant will be administered at protocol defined dose. |
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| Cycle 1 Days 1, 2, 8 and 9; Cycle 2 Day 1; Cycles 3 through 9 Day 1 (each cycle is 28 days) |
| PK parameters: Ctau | Ctau is defined as concentration at the end of the dosing interval | Cycle 1 Days 1, 2, 8 and 9; Cycle 2 Day 1; Cycles 3 through 9 Day 1 (each cycle is 28 days) |
| PK Parameters: AUC | Defined as the area under the plasma concentration-time curve | Cycle 1 Days 1, 2, 8 and 9; Cycle 2 Day 1; Cycles 3 through 9 Day 1 (each cycle is 28 days) |
| PK Parameters: CL/F | Defined as the apparent total body clearance of the drug from plasma | Cycle 1 Days 1, 2, 8 and 9; Cycle 2 Day 1; Cycles 3 through 9 Day 1 (each cycle is 28 days) |
| PK Parameters: Vz/F | Defined as apparent volume of distribution during terminal phase | Cycle 1 Days 1, 2, 8 and 9; Cycle 2 Day 1; Cycles 3 through 9 Day 1 (each cycle is 28 days) |
| PK Parameters: t1/2 | Defined as Elimination half-life (to be used in one-or noncompartmental model) | Cycle 1 Days 1, 2, 8 and 9; Cycle 2 Day 1; Cycles 3 through 9 Day 1 (each cycle is 28 days) |
| Objective Response Rate (ORR) | Defined as having a best overall Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1. | Up to 12 months |
| Disease Control | Defined as having a best overall response of CR, PR, or Stable Disease (SD) as determined by the investigator by radiographic disease assessment according to RECIST v1.1. | Up to 12 months |
| Duration of Response (DOR) | Defined as the time from earliest date of disease response (Completed Response or Partial Response) until earliest date of disease progression as determined by the investigator by radiographic disease assessment according to RECIST v1.1 or death due to any cause if occurring sooner than progression. | Up to 12 months |
| City of Hope-Lennar Foundation Cancer Center |
| Recruiting |
| Irvine |
| California |
| 92618 |
| United States |
| Valkyrie Clinical Trials | Recruiting | Los Angeles | California | 90067 | United States |
| Rocky Mountain Cancer Centers-Sky Ridge | Recruiting | Lone Tree | Colorado | 80124 | United States |
| Yale Cancer Center | Completed | New Haven | Connecticut | 06510 | United States |
| Mount Sinai Medical Center Comprehensive Cancer Center | Recruiting | Miami Beach | Florida | 33140 | United States |
| Emory University | Completed | Atlanta | Georgia | 30322 | United States |
| Memorial Sloan Kettering Cancer Center | Completed | New York | New York | 10022 | United States |
| New York Presbyterian/Weill Cornell | Completed | New York | New York | 10065 | United States |
| Ny Cancer and Blood Specialists | Not yet recruiting | Shirley | New York | 11967 | United States |
| Carolina Bio-Oncology Institute, Pllc | Completed | Huntersville | North Carolina | 28078 | United States |
| Cleveland Clinic | Withdrawn | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania Abramson Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Cancer Institute Cancer Services | Completed | Pittsburgh | Pennsylvania | 15213 | United States |
| Allegheny Health Network | Not yet recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
| Tennessee Oncology | Not yet recruiting | Nashville | Tennessee | 37203 | United States |
| Texas Oncology-Fort Worth South Henderson | Completed | Fort Worth | Texas | 76104 | United States |
| Virginia Cancer Institute | Recruiting | Fairfax | Virginia | 22031 | United States |
| University of Wisconsin | Not yet recruiting | Madison | Wisconsin | 53792 | United States |
| Institut Bergonie | Recruiting | Bordeaux | 33076 | France |
| Centre Leon Berard | Recruiting | Lyon | 69008 | France |
| Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole | Recruiting | Toulouse | 31059 | France |
| Institut Gustave Roussy | Recruiting | Villejuif | 94800 | France |
| Fondazione Irccs Istituto Nazionale Dei Tumori | Recruiting | Milan | 20133 | Italy |
| Istituto Nazionale Tumori Irccs Fondazione Pascale | Completed | Naples | 80131 | Italy |
| Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore | Recruiting | Rome | 00168 | Italy |
| Irccs Istituto Clinico Humanitas | Recruiting | Rozzano | 20089 | Italy |
| Centro Ricerche Cliniche Di Verona | Recruiting | Verona | 37134 | Italy |
| Aichi Cancer Center Hospital | Recruiting | Aichi | 464 8681 | Japan |
| National Cancer Center Hospital East | Recruiting | Chiba-ken | 277-0882 | Japan |
| Saitama Medical University International Medical Center | Recruiting | Hidaka-shi | 350-1298 | Japan |
| National Cancer Center Hospital | Recruiting | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital of Jfcr | Recruiting | Tokyo | 135-0063 | Japan |
| Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis | Recruiting | Amsterdam | 1066 CX | Netherlands |
| Erasmus Medical Center | Recruiting | Rotterdam | 3015 GD | Netherlands |
| Panoncology Trials Pan American Center For Oncology Trials, Llc | Recruiting | Rio Piedras | 00935 | Puerto Rico |
| Oncological Institute of Southern Switzerland | Recruiting | Bellinzona | 06500 | Switzerland |
| Inselspital Universitatsklinik Fur Medizinische Onkologie | Recruiting | Bern | CH-3010 | Switzerland |
| Centre Hospitalier Universitaire Vaudois (Chuv) | Recruiting | Lausanne | 01011 | Switzerland |
| Guys Hospital | Recruiting | London | SE1 9RT | United Kingdom |
| Imperial College Healthcare Nhs Trust - Hammersmith Hospital | Recruiting | London | W12 0HS | United Kingdom |
| Northern Centre For Cancer Care | Recruiting | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D004067 | Digestive System Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C500026 | palbociclib |
| D000068258 | Bevacizumab |
| C531550 | olaparib |
| D017239 | Paclitaxel |
| C000589651 | ribociclib |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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