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Solid TumorsPhase 1NCT04674748

To Assess the Safety, Tolerability and Pharmacokinetics of INCB086550

A Phase 1 study testing INCB086550 in people with Solid Tumors, run by Incyte Biosciences Japan GK at 2 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will assess the safety, tolerability, and PK of INCB086550 and determine the Maximum Tolerated Dose (MTD) and/or recommended Phase 2 Dose(RP2D) of INCB086550, whichever is lower, in Japanese participants with advanced solid tumors. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Solid Tumors
What is being tested?
INCB086550
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
2 sitesJapan
Study dates
3 Feb 2021to 13 May 2022
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to conform to and comply with all Protocol requirements, including all scheduled visits, Protocol procedures, and the ability to swallow oral medication.
  • Histologically or cytologically confirmed diagnosis of any locally advanced or metastatic solid tumors with measurable lesions per RECIST v1.1 not amenable to local or other curative therapy.
  • Disease progression after treatment with available therapies that are known to confer clinical benefit or intolerant to or ineligible for standard treatment.
  • ECOG performance status of 0 or 1.
  • Life expectancy > 12 weeks.
  • Female participants should agree to use medically acceptable contraceptive measures should not be breastfeeding, and must have a negative pregnancy test before the start of study drug administration if of childbearing potential.
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  • Female participants of childbearing potential must understand and accept that pregnancy must be avoided during participation in the study, from screening through 90 days after the last dose of study drug.
  • Male participants should avoid unprotected sex with women of childbearing potential during the study and for a washout period of 90 days after the last dose of study drug.
  • For participants who will be enrolled in the study and receive the RP2D of INCB086550 in the expanded cohort: Willingness to undergo a tumor biopsy to obtain tumor tissue. Pretreatment and on-treatment tumor biopsies are required.

Who cannot join

  • Laboratory values not within the Protocol-defined range.
  • Clinically significant cardiac disease, including left ventricular ejection fraction < 40%, unstable angina, acute myocardial infarction within 6 months of Cycle 1 Day 1, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy.
  • History or presence of abnormal ECG that, in the investigator's opinion, is clinically meaningful.
  • Untreated brain or CNS metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain or CNS metastases).
  • Active or inactive autoimmune disease or syndrome (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease) that has required systemic treatment in the past 2 years or receiving systemic therapy for an autoimmune or inflammatory disease (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
  • Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisolone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study drug. Use of short courses of steroids for procedure prophylaxis, inhaled or topical steroids, or systemic corticosteroids ≤ 10 mg is permitted.
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  • Known additional malignancy that is progressing or requires active treatment.
  • Evidence or a history of interstitial lung disease or active, noninfectious pneumonitis.
  • Treatment with anticancer medications or investigational drugs is prohibited within the following intervals before the first administration of study drug.
  • Concomitant treatment with moderate and potent CYP3A4/CYP3A5 inhibitors or inducers.
  • Receipt of a live vaccine within 3 months of the first dose of study drug.
  • Active infection requiring systemic therapy.
  • Systemic antibiotic therapy. A washout of 28 days is required before the first dose of INCB086550.
  • Probiotic supplement usage during screening and throughout the study treatment period.
  • Known active HBV or HCV infection or risk of reactivation of HBV or HCV.
  • History of organ transplant, including allogeneic stem cell transplantation.
  • Known hypersensitivity or severe reaction to any component of study drug or formulation components.
  • Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
  • Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
  • Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
  • Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
  • Women who are pregnant or breastfeeding.
  • Inability of the participant (or parent, guardian, or legally authorized representative) to comprehend the ICF or unwillingness to sign the ICF.

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • National Cancer Center Hospital - East

    Chiba, 277-8577

  • National Cancer Center Hospital

    Tokyo, 104-0045

Other trials in Japan

About this study

Official title: A Phase 1 Study Exploring the Safety, Tolerability, and Pharmacokinetics of INCB086550 in Japanese Participants With Advanced Solid Tumors

This study will assess the safety, tolerability, and PK of INCB086550 and determine the Maximum Tolerated Dose (MTD) and/or recommended Phase 2 Dose(RP2D) of INCB086550, whichever is lower, in Japanese participants with advanced solid tumors.

Conditions
Solid Tumors
Being tested
INCB086550
Keywords
Advanced, Metastatic, Refractory, Relapsed
Medical subject headings
Neoplasm Metastasis, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INCB086550Drug

    Each Participant will be treated at the specified dose level with a minimum of 3 subjects at each dose level. After the RP2D of INCB086550 is identified, the dose level will be expanded to better characterize the safety and tolerability and PK.

Study groups in NCT04674748
Study groupRoleWhat they receive
Dose Escalation of INCB086550ExperimentalIn this study 3 dose levels will be evaluated to determine the MTD or RP2D (Decided by SMC according to the safety and PK data)
Receives: Drug: INCB086550

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Treatment Emergent Adverse Events (TEAE)

    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

    Measured: Up to 27 months

Secondary outcomes (11)

  1. Objective Response Rate

    Defined as the percentage of participants with best overall response of CR or PR as determined by the investigator per RECIST v1.1.

    Measured: Up to 2 years

  2. Cmax

    Maximum Observed Plasma concentration of INCB086550

    Measured: Pre dose,Post dose on Cycle 1 Day 1 & Day 15, Pre dose on Cycle 1 Day 8, Cylce 2 Day 21, and Cycle 3 Day 1 (each cycle 28 days)

  3. Tmax

    Time to reach maximum (peak) Plasma concentration of INCB086550

    Measured: Pre dose,Post dose on Cycle 1 Day 1 & Day 15, Pre dose on Cycle 1 Day 8, Cylce 2 Day 21, and Cycle 3 Day 1 (each cycle 28 days)

  4. Cmin

    Trough plasma concentration of INCB086550

    Measured: Pre dose,Post dose on Cycle 1 Day 1 & Day 15, Pre dose on Cycle 1 Day 8, Cylce 2 Day 21, and Cycle 3 Day 1 (each cycle 28 days)

  5. AUC0-t

    Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration of INCB086550

    Measured: Pre dose,Post dose on Cycle 1 Day 1 & Day 15, Pre dose on Cycle 1 Day 8, Cylce 2 Day 21, and Cycle 3 Day 1 (each cycle 28 days)

  6. AUC0-∞

    area under the single-dose plasma concentration-time curve from Hour 0 to infinity of INCB086550

    Measured: Pre dose,Post dose on Cycle 1 Day 1 & Day 15, Pre dose on Cycle 1 Day 8, Cylce 2 Day 21, and Cycle 3 Day 1 (each cycle 28 days)

  7. AUC(0-τ)

    AUC to the end of dosing period of INCB086550

    Measured: Pre dose,Post dose on Cycle 1 Day 1 & Day 15, Pre dose on Cycle 1 Day 8, Cylce 2 Day 21, and Cycle 3 Day 1 (each cycle 28 days)

  8. t1/2

    Terminal half-life of INCB086550

    Measured: Pre dose,Post dose on Cycle 1 Day 1 & Day 15, Pre dose on Cycle 1 Day 8, Cylce 2 Day 21, and Cycle 3 Day 1 (each cycle 28 days)

  9. CL/F

    Oral dose clearance of INCB086550

    Measured: Pre dose,Post dose on Cycle 1 Day 1 & Day 15, Pre dose on Cycle 1 Day 8, Cylce 2 Day 21, and Cycle 3 Day 1 (each cycle 28 days)

  10. λz

    Terminal elimination rate constant of INCB086550

    Measured: Pre dose,Post dose on Cycle 1 Day 1 & Day 15, Pre dose on Cycle 1 Day 8, Cylce 2 Day 21, and Cycle 3 Day 1 (each cycle 28 days)

  11. Vz/F

    Apparent oral dose volume of distribution of INCB086550

    Measured: Pre dose,Post dose on Cycle 1 Day 1 & Day 15, Pre dose on Cycle 1 Day 8, Cylce 2 Day 21, and Cycle 3 Day 1 (each cycle 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2020
  2. Study start3 Feb 2021
  3. Primary completion13 May 2022
  4. Study completion13 May 2022

Why it stopped: The study was terminated early due to a business decision.

Resources

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
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04674748
Sponsor's protocol ID
INCB 86550-104
Status last verified
Sep 2025
First submitted
7 Dec 2020
Last updated
24 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INCB086550 in people with Solid Tumors, run by Incyte Biosciences Japan GK at 2 sites in Japan.

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 9 inclusion and 23 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: stopped early, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. 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 was stopped early (reason given: The study was terminated early due to a business decision.). Results are not available in the source record.

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 Participants with Treatment Emergent Adverse Events (TEAE) (time frame: Up to 27 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 NCT04674748.

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 24 Sep 2025.

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