INCB177054 + Retifanlimab for Solid Tumors

Recruiting at 8 trial locations

Overseen By Incyte Corporation Call Center (US)

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Incyte Corporation

Must not be taking: Anticancer, Investigational, Immunosuppressants, others

Disqualifiers: Invasive malignancy, CNS metastases, Transplant, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 12 months

322 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will be conducted to evaluate INCB177054 given as monotherapy or in combination with retifanlimab in participants with select advanced or metastatic solid Tumors.

Who Is on the Research Team?

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for adults with certain advanced or metastatic solid tumors, including uterine and other specific tumor locations. Participants must have a life expectancy over 12 weeks, be in good physical condition (ECOG score of 0-1), and have progressed after standard treatments or are unable to tolerate them. Specific groups include those suitable for immunotherapy and those with particular types of head, neck, lung cancer.

Inclusion Criteria

My doctor expects me to live more than 12 weeks.

I am fully active or restricted in physically strenuous activity but can do light work.

My solid tumor is growing and cannot be removed or cured with surgery or other treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INCB177054 as monotherapy or in combination with retifanlimab, with dose escalation and expansion phases

Up to approximately 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-emergent adverse events and disease response

Up to approximately 12 months and 45 days

What Are the Treatments Tested in This Trial?

Interventions

• INCB177054
• Retifanlimab

Trial Overview The study tests INCB177054 alone or combined with retifanlimab on participants with select solid tumors. It aims to find out how well these treatments work on different tumor types by observing disease progression using CT or MRI scans according to RECIST v1.1 criteria.

How Is the Trial Designed?

Group I: Part 2b: Dose Expansion combination Experimental Treatment 2 Interventions

INCB177054 in combination with retifanlimab at the protocol-defined dose strength based on cohort assignment.

Group II: Part 2a: Dose Escalation combination Experimental Treatment 2 Interventions

INCB177054 in combination with retifanlimab at the protocol-defined dose strength based on cohort assignment.

Group III: Part 1c: Dose Expansion monotherapy Experimental Treatment 1 Intervention

INCB177054 at the protocol-defined dose strength based on cohort assignment.

Group IV: Part 1b: Pharmacodynamic cohort Experimental Treatment 1 Intervention

INCB177054 at the protocol-defined dose strength based on cohort assignment.

Group V: Part 1a: Dose Escalation monotherapy Experimental Treatment 1 Intervention

INCB177054 at the protocol-defined dose strength based on cohort assignment.

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