INCB081776 + INCMGA00012 for Cancer

Recruiting at 23 trial locations

Overseen By Incyte Corporation Call Center (US)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Incyte Corporation

Must not be taking: Vitamin K antagonists, Corticosteroids

Disqualifiers: Retinal disease, Cardiac disease, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year

84 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug alone and with another drug to see if they are safe, how they work in the body, and if they show early signs of effectiveness in patients needing new treatments.

Research Team

Diane Hershock, MD

Principal Investigator

Incyte Corporation

Eligibility Criteria

This trial is for adults with advanced malignancies, including melanoma, lung cancer (NSCLC), head and neck cancer (SCCHN), soft-tissue sarcoma, and others. Participants must have measurable disease and may have received prior treatments as specified per cohort. They should be willing to undergo tumor biopsies but cannot join if they have significant heart issues, active autoimmune diseases requiring recent treatment, certain infections like hepatitis or HIV, or haven't recovered from previous therapy side effects.

Inclusion Criteria

I am 18 or older with advanced cancer and have tried or can't tolerate standard treatments.

I agree to have two biopsies of my tumor, one now and one during treatment.

My cancer is one of the specified types and is advanced or has spread.

Exclusion Criteria

I am currently on medication for an infection.

I have a serious heart condition.

History or presence of an ECG that, in the investigator's opinion, is clinically meaningful as per protocol-defined criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INCB081776 as a single agent or in combination with INCMGA00012

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Treatment Details

Interventions

• INCB081776
• INCMGA00012

Trial Overview The study tests the safety and effectiveness of INCB081776 alone (Part 1) and combined with INCMGA00012 (Part 2). It will assess how these drugs are processed in the body and their impact on tumors. The trial aims to find out if these interventions can help treat various types of advanced cancers by monitoring early clinical activity.

Participant Groups

Group I: INCB081776 + INCMGA00012 Experimental Treatment 2 Interventions

INCB081776 in combination with INCMGA00012.

Group II: INCB081776 Experimental Treatment 1 Intervention

Single-agent INCB081776.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School