A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors

Incyte Corporation25 sites in 5 countries138 target enrollmentDecember 10, 2018

ConditionsSolid Tumors

InterventionsINCB086550

Overview

Phase: Phase 1
Intervention: INCB086550
Conditions: Solid Tumors
Sponsor: Incyte Corporation
Enrollment: 138
Locations: 25
Primary Endpoint: Number of treatment-emergent adverse events
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 10, 2018

End Date

November 17, 2023

Last Updated

8 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Incyte Corporation

Responsible Party

Sponsor

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
•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.

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).

Arms & Interventions

INCB086550

Intervention: INCB086550

Outcomes

Primary Outcomes

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.

Secondary Outcomes

AUC0-tau of INCB086550 in fasted and food effect conditions(Approximately 1 month)
Vz/F of INCB086550(Approximately 1 month)
tmax of INCB086550 in fasted and food effect conditions(Approximately 1 month)
Disease control rate(Every 8 weeks for the duration of study participation; estimated to be 12 months.)
Cmax of INCB086550 in fasted and food effect conditions(Approximately 1 month)
Objective response rate(Every 8 weeks for the duration of study participation; estimated to be 12 months.)
AUC 0-t and/or AUC0-∞ of INCB086550 in fasted and food effect conditions(Approximately 1 month)
t½ of INCB086550(Approximately 1 month)
λz of INCB086550(Approximately 1 month)
CL/F of INCB086550(Approximately 1 month)
Pharmacokinetic/pharmacodynamics correlation(Approximately 1 month)
Cmin of INCB086550 in fasted and food effect conditions(Approximately 1 month)
Duration of response(Every 8 weeks for the duration of study participation; estimated to be 12 months.)