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A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy in Participants With Selected Advanced Solid Tumors

Clinical Trial Details

This clinical trial is for adult participants who have an advanced or metastatic solid tumor and have received prior standard therapy.
   
The purpose of this study is to evaluate the safety, tolerability, and preliminary effectiveness of the study drug INCB123667 for use in the treatment of advanced or metastatic solid tumors of participants who have received prior standard therapy. Different doses will be tested in this study to find a safe and tolerable dose. The purpose is also to understand how the study drug spreads in a participant’s body.

INCB123667 is an investigational drug, meaning it has not been approved by the US Food and Drug Administration (FDA). INCB123667 has been tested in animals but not yet in people.

INCB123667 is a tablet that participants will receive daily by mouth with water. One treatment cycle lasts 28 days. There are differences between this study and participants’ usual care. For those who take part in the study, the main differences are that they will have more visits with their study doctor, more frequent blood and urine tests, and more ECGs and radiologic imaging. Participants may be required to undergo one or more biopsies and provide the collected tumor samples. The study doctor will tell participants if this is applicable to them, as well as explain which procedures are being done for the study, and which would be done as part of their usual care.

There is no predefined length of time for participation. Participants will receive the study drug until their disease worsens, they do not tolerate the study drug correctly, or they start new anticancer therapy. However, according to the study drug data currently available, it is anticipated that participants will remain on the study drug for approximately 12 months.

Key Eligibility: 
  1. Adults with histologically or cytologically confirmed advanced or metastatic solid tumors.
  2. Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available treatment to improve the disease outcome.

Detailed eligibility reviewed when participants contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Kathleen Pogonowski, RN
(646) 962-6500
kap9111@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2305026062

ClinicalTrials.gov:

NCT05238922

Sponsor:

INCB 123667-101

Status

Open to Enrollment

Age Group

Adult

Sponsor