To Assess the Safety, Tolerability and Pharmacokinetics of INCB086550

NCT04674748 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: INCB 86550-104
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Solid Tumors

Keywords

Advanced; Metastatic; Refractory; Relapsed

Outcome Measures

Primary Outcomes (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.

  Up to 27 months

Secondary Outcomes (11)

• Objective Response Rate

  Up to 2 years

• Cmax

  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)

• Tmax

  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)

• Cmin

  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)

• AUC0-t

  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)

Study Arms (1)

Dose Escalation of INCB086550

EXPERIMENTAL

In this study 3 dose levels will be evaluated to determine the MTD or RP2D (Decided by SMC according to the safety and PK data)

Drug: INCB086550

Interventions

INCB086550 DRUG

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.

Dose Escalation of INCB086550

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Incyte Biosciences Japan GK: lead

Study Sites (2)

National Cancer Center Hospital - East

Chiba, 277-8577, Japan

Location

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Recurrence

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Design

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

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 19, 2020
• Study Start: February 3, 2021
• Primary Completion: May 13, 2022
• Study Completion: May 13, 2022
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

JP (2)