A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced solid tumors who have failed prior treatments.

Key facts

Study ID

NCT03762447

Run by

Incyte Corporation

People needed

138

Starts

2018-12-10

Expected to finish

2023-11-17

Last updated by the study team

2025-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed advanced solid tumors with measurable lesions per RECIST v1.1 or RANO for primary brain tumors that are considered nonamenable to surgery or other curative treatments or procedures. Tumor lesions located in a previously irradiated area, or in an area subjected to other loco-regional therapy, are considered measurable per RECIST v1.1 if progression has been demonstrated in the lesion.
• Willingness to undergo a tumor biopsy to obtain tumor tissue,Pretreatment and on-treatment tumor biopsies are required.
• Must have disease progression after treatment with available therapies that are known to confer clinical benefit or who are intolerant to or ineligible for standard treatment. There is no limit to the number of prior treatment regimens.
• Eastern Cooperative Oncology Group performance status score of 0 or 1.
• Life expectancy > 12 weeks.
• Willingness to avoid pregnancy or fathering children.
• Part 2 Expansion Cohort 2-A only: Participants with any type of solid tumor that has a local regulatory approval for an anti-PD-1 therapy. Other tumor types may be enrolled with medical monitor approval. Participants must have had confirmed disease progression on a prior anti-PD-1 monoclonal antibody.
• Part 2 Expansion Cohort 2-B only: Participants with select solid tumors who are immunotherapy-naïve.
• Part 3 MSI-H or dMMR Expansion Cohort only (Enrolled ex-United States only): Participants with any MSI-H or dMMR solid tumor who are immunotherapy-naïve.
• Part 4 HPV-driven expansion cohort only: Participants with any HPV-positive solid tumor who have received prior standard therapy.
• Note: HPV-positive status determined by a local laboratory using p16 IHC, polymerase chain reaction methods, or other locally-available method to detect HPV

You may not qualify if…

• Laboratory values not within the Protocol-defined range.
• Clinically significant cardiac disease.
• History or presence of an ECG that, in the investigator's opinion, is clinically meaningful.
• Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed. Participants who have previously treated and clinically stable brain or CNS metastases and have not required steroids for at least 7 days before study treatment are eligible.
• Known additional malignancy that is progressing or requires active treatment.
• Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study treatment.
• Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
• Active infection requiring systemic therapy.
• Active HBV or HCV infection that requires treatment.
• Known history of HIV (HIV 1/2 antibodies).
• Known hypersensitivity or severe reaction to any component of study drug or formulation components.
• Prior receipt of an anti-PD-L1 therapy for all participants.
• Presence of a gastrointestinal condition that may affect drug absorption.

Where it is running

• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• H. Lee Moffitt Cancer Center and Research Institute Hospital — Tampa, Florida, United States
• Aamc Oncology and Hematology — Annapolis, Maryland, United States
• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
• Jefferson University Hospitals — Philadelphia, Pennsylvania, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Md Anderson Cancer Center — Houston, Texas, United States
• Institut Jules Bordet — Brussels, Belgium
• Universitair Ziekenhuis Antwerpen (Uza) — Edegem, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• Universitaire Ziekenhuis Leuven - Gasthuisberg — Leuven, Belgium
• Chu Hopital de La Timone — Marseille, France
• Icm Montpellier — Montpellier, France
• Institut Curie — Paris, France
• Institut Universitaire Du Cancer de Toulouse Oncopole — Toulouse, France
• Fondazione Irccs Istituto Nazionale Dei Tumori — Milan, Italy
• European Institute of Oncology — Milan, Italy
• Istituto Nazionale Tumori Irccs Fondazione Pascale — Naples, Italy
• Irrcs Instituto Clinico Humanitas — Rozzano, Italy
• Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte — Siena, Italy
• Addenbrooke'S Hospital — Cambridge, United Kingdom
• Guys and St Thomas Nhs Foundation Trust — London, United Kingdom
• Imperial College Healthcare Nhs Trust - Hammersmith Hospital — London, United Kingdom
• The Christie Nhs Foundation Trust Uk — Manchester, United Kingdom
• Weston Park Hospital — Sheffield, United Kingdom

Full record on ClinicalTrials.gov

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