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

NCT03762447 | Completed Phase 1 FDA Drug

• 2 other identifiers: INCB 86550-1022019-004377-27
• Study Type: interventional
• Target: 138
• Locations: 5 countries
• Sites: 25

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

Keywords

solid tumors

Outcome Measures

Primary Outcomes (1)

• Number of treatment-emergent adverse events

  Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

  Baseline through 90 days after end of treatment, estimated up to 12 months.

Secondary Outcomes (13)

• Cmax of INCB086550 in fasted and food effect conditions

  Approximately 1 month

• tmax of INCB086550 in fasted and food effect conditions

  Approximately 1 month

• AUC0-tau of INCB086550 in fasted and food effect conditions

  Approximately 1 month

• AUC 0-t and/or AUC0-∞ of INCB086550 in fasted and food effect conditions

  Approximately 1 month

• t½ of INCB086550

  Approximately 1 month

Study Arms (1)

INCB086550

EXPERIMENTAL

Drug: INCB086550

Interventions

INCB086550 DRUG

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

INCB086550

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (25)

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

H. Lee Moffitt Cancer Center and Research Institute Hospital

Tampa, Florida, 33612, United States

Location

Aamc Oncology and Hematology

Annapolis, Maryland, 21401, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Jefferson University Hospitals

Philadelphia, Pennsylvania, 19107, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Institut Jules Bordet

Brussels, 01000, Belgium

Location

Universitair Ziekenhuis Antwerpen (Uza)

Edegem, 02650, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 09000, Belgium

Location

Universitaire Ziekenhuis Leuven - Gasthuisberg

Leuven, 03000, Belgium

Location

Chu Hopital de La Timone

Marseille, 13385, France

Location

Icm Montpellier

Montpellier, 34298, France

Location

Institut Curie

Paris, 75005, France

Location

Institut Universitaire Du Cancer de Toulouse Oncopole

Toulouse, 31059, France

Location

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, 20133, Italy

Location

European Institute of Oncology

Milan, 20141, Italy

Location

Istituto Nazionale Tumori Irccs Fondazione Pascale

Napoli, 80131, Italy

Location

Irrcs Instituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

Siena, 53100, Italy

Location

Addenbrooke'S Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Guys and St Thomas Nhs Foundation Trust

London, SE1 9RT, United Kingdom

Location

Imperial College Healthcare Nhs Trust - Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

The Christie Nhs Foundation Trust Uk

Manchester, M20 4BX, United Kingdom

Location

Weston Park Hospital

Sheffield, S10 2SJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35254416 DERIVED

Study Officials

• Kevin O'Hayer, MD, PhD

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: December 3, 2018
• Study Start: December 10, 2018
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); BE (4); IT (5); GB (5); US (7)