INCB099280 for Skin Cancer

Recruiting in Palo Alto (17 mi)

+129 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Incyte Corporation

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called INCB099280 to see if it is safe and works well for people with advanced skin cancer. The drug aims to stop the cancer cells from growing by blocking certain signals.

Eligibility Criteria

This trial is for adults with advanced Cutaneous Squamous Cell Carcinoma (cSCC) that can't be cured by surgery or radiotherapy. Participants should have measurable disease, an ECOG score of 0 or 1 indicating they are fully active or restricted in physically strenuous activity but ambulatory, and a life expectancy over three months. They must not be at risk of pregnancy or fathering children.

Inclusion Criteria

I am fully active or have some restrictions but can still care for myself.

My condition is confirmed as cutaneous squamous cell carcinoma.

My skin cancer cannot be cured with surgery or radiation and has not been treated or has come back.

+3 more

Exclusion Criteria

I am not taking probiotics during the study.

I am not in another clinical study while taking INCB099280.

I have brain metastases needing treatment or a condition affecting the lining of my brain.

+15 more

Participant Groups

The study tests the safety and effectiveness of INCB099280 on patients with cSCC. It aims to find out how well this drug works and what side effects it might cause when given to people who either haven't been treated before or whose cancer has returned after treatment.

4Treatment groups

Experimental Treatment

Group I: Part 2: INCB099280 Dose selected from Part 1Experimental Treatment1 Intervention

Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years.

Group II: Part 1: INCB099280 Dose 3Experimental Treatment1 Intervention

Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years.

Group III: Part 1: INCB099280 Dose 2Experimental Treatment1 Intervention

Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years.

Group IV: Part 1: INCB099280 Dose 1Experimental Treatment1 Intervention

Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years.