Solid TumorsPhase 1NCT03762447
A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors
A Phase 1 study testing INCB086550 in people with Solid Tumors, run by Incyte Corporation at 25 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- INCB086550
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 25 sitesin 5 countries
- Study dates
- 10 Dec 2018to 17 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
25 sites in 5 countries.
25 sites in 5 countries
United States7 sites
Aamc Oncology and Hematology
Annapolis, Maryland, 21401
Md Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Jefferson University Hospitals
Philadelphia, Pennsylvania, 19107
H. Lee Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida, 33612
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Italy5 sites
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, 20133
European Institute of Oncology
Milan, 20141
Istituto Nazionale Tumori Irccs Fondazione Pascale
Naples, 80131
Irrcs Instituto Clinico Humanitas
Rozzano, 20089
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
Siena, 53100
United Kingdom5 sites
Addenbrooke'S Hospital
Cambridge, CB2 0QQ
Guys and St Thomas Nhs Foundation Trust
London, SE1 9RT
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London, W12 0HS
The Christie Nhs Foundation Trust Uk
Manchester, M20 4BX
Weston Park Hospital
Sheffield, S10 2SJ
Belgium4 sites
Institut Jules Bordet
Brussels, 01000
Universitair Ziekenhuis Antwerpen (Uza)
Edegem, 02650
Universitair Ziekenhuis Gent
Ghent, 09000
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven, 03000
France4 sites
Chu Hopital de La Timone
Marseille, 13385
Icm Montpellier
Montpellier, 34298
Institut Curie
Paris, 75005
Institut Universitaire Du Cancer de Toulouse Oncopole
Toulouse, 31059
About this study
Official title: A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors
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
- Being tested
- INCB086550
- Keywords
- solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB086550Drug
INCB086550 will be orally administered once or twice daily in continuous or intermittent dose schedules.
| Study group | Role | What they receive |
|---|---|---|
| INCB086550 | Experimental | Not described Receives: Drug: INCB086550 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Maximum observed plasma or serum concentration.
Measured: Approximately 1 month
tmax of INCB086550 in fasted and food effect conditions
Time to maximum concentration.
Measured: Approximately 1 month
AUC0-tau of INCB086550 in fasted and food effect conditions
Area under the plasma or serum concentration-time curve from time = 0 to the end of dosing period at steady state
Measured: Approximately 1 month
AUC 0-t and/or AUC0-∞ of INCB086550 in fasted and food effect conditions
Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration, or Area under the single-dose plasma concentration-time curve from Hour 0 to infinity
Measured: Approximately 1 month
t½ of INCB086550
Apparent terminal-phase disposition half-life.
Measured: Approximately 1 month
λz of INCB086550
Apparent terminal-phase disposition rate constant
Measured: Approximately 1 month
CL/F of INCB086550
Apparent oral dose clearance.
Measured: Approximately 1 month
Vz/F of INCB086550
Apparent oral dose volume of distribution.
Measured: Approximately 1 month
Pharmacokinetic/pharmacodynamics correlation
Evaluation of the ability of INCB086550 to modulate PD-L1 expression levels as assessed by flow cytometry protein analyses.
Measured: Approximately 1 month
Objective response rate
Defined as the percentage of participants having complete response (CR) or partial response (PR) by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or response assessment in Neuro-Oncology (RANO).
Measured: Every 8 weeks for the duration of study participation; estimated to be 12 months.
Disease control rate
Defined as the percentage of participants having CR, PR, or stable disease ≥ 12 weeks by investigator assessment of radiographic disease assessments per RECIST v1.1 or response assessment in Neuro-Oncology (RANO).
Measured: Every 8 weeks for the duration of study participation; estimated to be 12 months.
Duration of response
Defined as the time from the first documented evidence of CR or PR until the earliest date of disease progression by investigator assessment per RECIST v1.1 for response assessment in Neuro-Oncology (RANO), or death due to any cause, if occurring sooner than progression.
Measured: Every 8 weeks for the duration of study participation; estimated to be 12 months.
Cmin of INCB086550 in fasted and food effect conditions
Minimum observed plasma or serum concentration of INCB086550
Measured: Approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start10 Dec 2018
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin O'Hayer, MD, PhD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762447
- Sponsor's protocol ID
- INCB 86550-102
- Other IDs
- 2019-004377-27, 2019
- Status last verified
- Aug 2025
- First submitted
- 19 Nov 2018
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35254416
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03762447
- Acronym / sponsor ID
- INCB 86550-102
- Conditions
- Solid Tumors
- Keywords
- solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INCB086550 | Experimental | Drug: INCB086550 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCB086550INCB086550 will be orally administered once or twice daily in continuous or intermittent dose schedules. | Drug | INCB086550 |
Primary outcome
Number of treatment-emergent adverse events
Time frame: Baseline through 90 days after end of treatment, estimated up to 12 months.
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
13 secondary outcomes
Cmax of INCB086550 in fasted and food effect conditions
Time frame: Approximately 1 month
tmax of INCB086550 in fasted and food effect conditions
Time frame: Approximately 1 month
AUC0-tau of INCB086550 in fasted and food effect conditions
Time frame: Approximately 1 month
AUC 0-t and/or AUC0-∞ of INCB086550 in fasted and food effect conditions
Time frame: Approximately 1 month
t½ of INCB086550
Time frame: Approximately 1 month
λz of INCB086550
Time frame: Approximately 1 month
CL/F of INCB086550
Time frame: Approximately 1 month
Vz/F of INCB086550
Time frame: Approximately 1 month
Pharmacokinetic/pharmacodynamics correlation
Time frame: Approximately 1 month
Objective response rate
Time frame: Every 8 weeks for the duration of study participation; estimated to be 12 months.
Disease control rate
Time frame: Every 8 weeks for the duration of study participation; estimated to be 12 months.
Duration of response
Time frame: Every 8 weeks for the duration of study participation; estimated to be 12 months.
Cmin of INCB086550 in fasted and food effect conditions
Time frame: Approximately 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Derived from this study: PubMed 35254416Koblish 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin O'Hayer, MD, PhD study director
Incyte Corporation
25 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCB086550 in people with Solid Tumors, run by Incyte Corporation at 25 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Italy, United Kingdom, Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment-emergent adverse events (time frame: Baseline through 90 days after end of treatment, estimated up to 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03762447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.