Solid TumorsPhase 1NCT05238922
Study of INCB123667 in Subjects With Advanced Solid Tumors
A Phase 1 study testing INCB0123667, Palbociclib and Bevacizumab in people with Solid Tumors, run by Incyte Corporation at 41 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- INCB0123667, Palbociclib and Bevacizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 41 sitesin 8 countries
- Study dates
- 5 Jul 2022to 31 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
41 sites in 8 countries.
41 sites in 8 countries
United States18 sites
Emory University
Atlanta, Georgia, 30322
City of Hope Medical Center
Duarte, California, 91010
Virginia Cancer Institute
Fairfax, Virginia, 22031
Texas Oncology-Fort Worth South Henderson
Fort Worth, Texas, 76104
Carolina Bio-Oncology Institute, Pllc
Huntersville, North Carolina, 28078
City of Hope-Lennar Foundation Cancer Center
Irvine, California, 92618
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124
Valkyrie Clinical Trials
Los Angeles, California, 90067
University of Wisconsin
Madison, Wisconsin, 53792
Mount Sinai Medical Center Comprehensive Cancer Center
Miami Beach, Florida, 33140
Tennessee Oncology
Nashville, Tennessee, 37203
Yale Cancer Center
New Haven, Connecticut, 06510
Memorial Sloan Kettering Cancer Center
New York, New York, 10022
New York Presbyterian/Weill Cornell
New York, New York, 10065
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Cancer Institute Cancer Services
Pittsburgh, Pennsylvania, 15213
Allegheny Health Network
Pittsburgh, Pennsylvania, 15224
Ny Cancer and Blood Specialists
Shirley, New York, 11967
Italy5 sites
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, 20133
Istituto Nazionale Tumori Irccs Fondazione Pascale
Naples, 80131
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Rome, 00168
Irccs Istituto Clinico Humanitas
Rozzano, 20089
Centro Ricerche Cliniche Di Verona
Verona, 37134
Japan5 sites
Aichi Cancer Center Hospital
Aichi, 464 8681
National Cancer Center Hospital East
Chiba-ken, 277-0882
Saitama Medical University International Medical Center
Hidaka-shi, 350-1298
National Cancer Center Hospital
Tokyo, 104-0045
The Cancer Institute Hospital of Jfcr
Tokyo, 135-0063
France4 sites
Institut Bergonie
Bordeaux, 33076
Centre Leon Berard
Lyon, 69008
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole
Toulouse, 31059
Institut Gustave Roussy
Villejuif, 94800
Switzerland3 sites
Oncological Institute of Southern Switzerland
Bellinzona, 06500
Inselspital Universitatsklinik Fur Medizinische Onkologie
Bern, CH-3010
Centre Hospitalier Universitaire Vaudois (Chuv)
Lausanne, 01011
United Kingdom3 sites
Guys Hospital
London, SE1 9RT
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London, W12 0HS
Northern Centre For Cancer Care
Newcastle upon Tyne, NE7 7DN
Netherlands2 sites
Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, 1066 CX
Erasmus Medical Center
Rotterdam, 3015 GD
Puerto Rico1 site
Panoncology Trials Pan American Center For Oncology Trials, Llc
Rio Piedras, 00935
About this study
Official title: A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy and in Combination With Anticancer Therapies in Participants With Selected Advanced Solid Tumors
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).
- Conditions
- Solid Tumors
- Being tested
- INCB0123667, Palbociclib, Bevacizumab, Olaparib, Paclitaxel
- Keywords
- advanced solid tumors, metastatic solid tumors, Gynecological Tumors,, GI Tumors,, Breast Cancer,, Tumor Agnostic, cyclin E1 gene, epithelial ovarian carcinoma, fallopian carcinoma, primary peritoneal carcinoma, clear cell ovarian cancer, endometrial adenocarcinoma, uterine carcinosarcoma, uterine papillary serous carcinoma, gastrointestinal tumors, gastric adenocarcinomas, GEJ adenocarcinomas, esophageal adenocarcinomas
- Medical subject headings
- Breast Neoplasms, Carcinoma, Ovarian Epithelial, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB0123667Drug
25 mg tablets
PalbociclibDrug
Palbociclib will be administered at protocol defined dose.
BevacizumabDrug
Bevacizumab will be administered at protocol defined dose.
OlaparibDrug
Olaparib will be administered at protocol defined dose.
PaclitaxelDrug
Paclitaxel will be administered at protocol defined dose.
RibociclibDrug
Ribociclib will be administered at protocol defined dose.
FulvestrantDrug
Fulvestrant will be administered at protocol defined dose.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: INCB0123667 |
| 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. Receives: Drug: INCB0123667 |
| 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. Receives: Drug: INCB0123667 |
| 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. Receives: Drug: INCB0123667 |
| Phase 1b: Dose Expansion Cohort Disease Group 4 | 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. Receives: Drug: INCB0123667 |
| 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. Receives: Drug: INCB0123667 |
| 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. Receives: Drug: INCB0123667 |
| 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. Receives: Drug: INCB0123667; Drug: Palbociclib |
| 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. Receives: Drug: INCB0123667; Drug: Palbociclib; Drug: Fulvestrant |
| 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. Receives: Drug: INCB0123667; Drug: Ribociclib |
| 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. Receives: Drug: INCB0123667; Drug: Ribociclib; Drug: Fulvestrant |
| 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. Receives: Drug: INCB0123667; Drug: Bevacizumab |
| 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. Receives: Drug: INCB0123667; Drug: Olaparib |
| 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. Receives: Drug: INCB0123667; Drug: Paclitaxel |
| 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. Receives: Drug: INCB0123667; Drug: Palbociclib |
| 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 Receives: Drug: INCB0123667; Drug: Palbociclib; Drug: Fulvestrant |
| 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. Receives: Drug: INCB0123667; Drug: Ribociclib |
| 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. Receives: Drug: INCB0123667; Drug: Ribociclib; Drug: Fulvestrant |
| 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. Receives: Drug: INCB0123667; Drug: Bevacizumab |
| 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. Receives: Drug: INCB0123667; Drug: Olaparib |
| 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. Receives: Drug: INCB0123667; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Secondary outcomes (10)
PK parameters: Cmax
Defines as the maximum (peak) plasma drug concentration
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start5 Jul 2022
- Primary completion27 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Louis Viviers, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238922
- Sponsor's protocol ID
- INCB 123667-101
- Other IDs
- 2021-005357-91
- Status last verified
- Jul 2026
- First submitted
- 31 Jan 2022
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy and in Combination With Anticancer Therapies in Participants With Selected Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05238922
- Acronym / sponsor ID
- INCB 123667-101
- Conditions
- Solid Tumors
- Keywords
- advanced solid tumors, metastatic solid tumors, Gynecological Tumors,, GI Tumors,, Breast Cancer,, Tumor Agnostic, cyclin E1 gene, epithelial ovarian carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 27 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 21
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Dose Escalation | Experimental | Drug: INCB0123667INCB123667 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 | Drug: INCB0123667INCB123667 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 | Drug: INCB0123667INCB123667 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 | Drug: INCB0123667INCB123667 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 | Experimental | Drug: INCB0123667INCB123667 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 | Drug: INCB0123667INCB123667 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 | Drug: INCB0123667INCB123667 will be administered at the recommended dose or doses for expansion (RDE[s]) for advanced or metastatic solid tumors will enroll in this group. |
| Phase 2a Dose Escalation Treatment Group A (TGA) | Experimental | Drug: INCB0123667, Drug: PalbociclibINCB123667 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. |
| Phase 2a Dose Escalation Treatment Group B (TGB) | Experimental | Drug: INCB0123667, Drug: Palbociclib, Drug: FulvestrantINCB123667 administered in combination with palbociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol. |
| Phase 2a Dose Escalation Treatment Group C (TGC) | Experimental | Drug: INCB0123667, Drug: RibociclibINCB123667 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 | Drug: INCB0123667, Drug: Ribociclib, Drug: FulvestrantINCB123667 administered in combination with ribociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol. |
| Phase 2a Dose Escalation Treatment Group E (TGE) | Experimental | Drug: INCB0123667, Drug: BevacizumabINCB123667 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. |
| Phase 2a Dose Escalation Treatment Group F (TGF) | Experimental | Drug: INCB0123667, Drug: OlaparibINCB123667 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. |
| Phase 2a Dose Escalation Treatment Group G (TGG) | Experimental | Drug: INCB0123667, Drug: PaclitaxelINCB123667 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. |
| Phase 2b Dose Expansion Treatment Group H (TGH) | Experimental | Drug: INCB0123667, Drug: PalbociclibINCB123667 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. |
| Phase 2b Dose Expansion Treatment Group I (TGI) | Experimental | Drug: INCB0123667, Drug: Palbociclib, Drug: FulvestrantINCB123667 administered in combination with palbociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol |
| Phase 2b Dose Expansion Treatment Group J (TGJ) | Experimental | Drug: INCB0123667, Drug: RibociclibINCB123667 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 2b Dose Expansion Treatment Group K (TGK) | Experimental | Drug: INCB0123667, Drug: Ribociclib, Drug: FulvestrantINCB123667 administered in combination with ribociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol. |
| Phase 2b Dose Expansion Treatment Group L (TGL) | Experimental | Drug: INCB0123667, Drug: BevacizumabINCB123667 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. |
| Phase 2b Dose Expansion Treatment Group M (TGM) | Experimental | Drug: INCB0123667, Drug: OlaparibINCB123667 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. |
| Phase 2b Dose Expansion Treatment Group N (TGN) | Experimental | Drug: INCB0123667, Drug: PaclitaxelINCB123667 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCB012366725 mg tablets | Drug | Phase 1a Dose Escalation, Phase 1b: Dose Expansion Cohort Disease Group 1, Phase 1b: Dose Expansion Cohort Disease Group 2, Phase 1b: Dose Expansion Cohort Disease Group 3, Phase 1b: Dose Expansion Cohort Disease Group 4, Phase 1b: Dose Expansion Cohort Disease Group 5, Phase 1b: Dose Expansion Cohort Disease Group 6, Phase 2a Dose Escalation Treatment Group A (TGA), Phase 2a Dose Escalation Treatment Group B (TGB), Phase 2a Dose Escalation Treatment Group C (TGC), Phase 2a Dose Escalation Treatment Group D (TGD), Phase 2a Dose Escalation Treatment Group E (TGE), Phase 2a Dose Escalation Treatment Group F (TGF), Phase 2a Dose Escalation Treatment Group G (TGG), Phase 2b Dose Expansion Treatment Group H (TGH), Phase 2b Dose Expansion Treatment Group I (TGI), Phase 2b Dose Expansion Treatment Group J (TGJ), Phase 2b Dose Expansion Treatment Group K (TGK), Phase 2b Dose Expansion Treatment Group L (TGL), Phase 2b Dose Expansion Treatment Group M (TGM), Phase 2b Dose Expansion Treatment Group N (TGN) |
| PalbociclibPalbociclib will be administered at protocol defined dose. | Drug | Phase 2a Dose Escalation Treatment Group A (TGA), Phase 2a Dose Escalation Treatment Group B (TGB), Phase 2b Dose Expansion Treatment Group H (TGH), Phase 2b Dose Expansion Treatment Group I (TGI) |
| BevacizumabBevacizumab will be administered at protocol defined dose. | Drug | Phase 2a Dose Escalation Treatment Group E (TGE), Phase 2b Dose Expansion Treatment Group L (TGL) |
| OlaparibOlaparib will be administered at protocol defined dose. | Drug | Phase 2a Dose Escalation Treatment Group F (TGF), Phase 2b Dose Expansion Treatment Group M (TGM) |
| PaclitaxelPaclitaxel will be administered at protocol defined dose. | Drug | Phase 2a Dose Escalation Treatment Group G (TGG), Phase 2b Dose Expansion Treatment Group N (TGN) |
| RibociclibRibociclib will be administered at protocol defined dose. | Drug | Phase 2a Dose Escalation Treatment Group C (TGC), Phase 2a Dose Escalation Treatment Group D (TGD), Phase 2b Dose Expansion Treatment Group J (TGJ), Phase 2b Dose Expansion Treatment Group K (TGK) |
| FulvestrantFulvestrant will be administered at protocol defined dose. | Drug | Phase 2a Dose Escalation Treatment Group B (TGB), Phase 2a Dose Escalation Treatment Group D (TGD), Phase 2b Dose Expansion Treatment Group I (TGI), Phase 2b Dose Expansion Treatment Group K (TGK) |
Primary outcome
Part 1A : Occurrence of Dose Limiting Toxicities (DLTs)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
10 secondary outcomes
PK parameters: Cmax
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Up to 12 months
Disease Control
Time frame: Up to 12 months
Duration of Response (DOR)
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Study of INCB123667 in Subjects with Advanced Solid TumorsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Viviers, MD study director
Incyte Corporation
41 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCB0123667, Palbociclib and Bevacizumab in people with Solid Tumors, run by Incyte Corporation at 41 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Italy, Japan, France, Switzerland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1A : Occurrence of Dose Limiting Toxicities (DLTs) (time frame: Up to Day 28). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.