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

NCT ID: NCT03762447

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-10
• Study Completion Date: 2023-11-17

Brief Summary

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.

Conditions

Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

INCB086550

Group Type: EXPERIMENTAL

INCB086550

Intervention Type: DRUG

INCB086550 will be orally administered once or twice daily in continuous or intermittent dose schedules.

Interventions

INCB086550

INCB086550 will be orally administered once or twice daily in continuous or intermittent dose schedules.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin O'Hayer, MD, PhD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

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

Napoli, , 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

Countries

United States; Belgium; France; Italy; United Kingdom

References

Koblish HK, Wu L, Wang LS, Liu PCC, Wynn R, Rios-Doria J, Spitz S, Liu H, Volgina A, Zolotarjova N, Kapilashrami K, Behshad E, Covington M, Yang YO, Li J, Diamond S, Soloviev M, O'Hayer K, Rubin S, Kanellopoulou C, Yang G, Rupar M, DiMatteo D, Lin L, Stevens C, Zhang Y, Thekkat P, Geschwindt R, Marando C, Yeleswaram S, Jackson J, Scherle P, Huber R, Yao W, Hollis G. Characterization of INCB086550: A Potent and Novel Small-Molecule PD-L1 Inhibitor. Cancer Discov. 2022 Jun 2;12(6):1482-1499. doi: 10.1158/2159-8290.CD-21-1156.

Reference Type: DERIVED

PMID: 35254416 (View on PubMed)

Other Identifiers

2019-004377-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

INCB 86550-102

Identifier Type: -

Identifier Source: org_study_id