RecruitingPhase 1

Study of INCB123667 in Subjects With Advanced Solid Tumors

United States604 participantsStarted 2022-07-05

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. * TG…

What they're measuring

Part 1A : Occurrence of Dose Limiting Toxicities (DLTs)

Timeframe: Up to Day 28

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Timeframe: Up to 12 months

Number of Participants with Dose Interruptions due to TEAE

Timeframe: Up to 12 months

Number of Participants who Undergo Dose Reductions due to TEAE

Timeframe: Up to 12 months

Number of Participants Discontinue study due to TEAE

Timeframe: Up to 12 months

Trial details

NCT IDNCT05238922

SponsorIncyte Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-27

Contact for this trial

Incyte Corporation Call Center (US)

1.855.463.3463 medinfo@incyte.com

View on ClinicalTrials.gov More Solid Tumors trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part 1A : Occurrence of Dose Limiting Toxicities (DLTs)

Timeframe: Up to Day 28

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Timeframe: Up to 12 months

Number of Participants with Dose Interruptions due to TEAE

Timeframe: Up to 12 months

Number of Participants who Undergo Dose Reductions due to TEAE

Timeframe: Up to 12 months

Number of Participants Discontinue study due to TEAE

Timeframe: Up to 12 months