A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Select Advanced Solid Tumors

Incyte Corporation24 sites in 7 countries105 target enrollmentMarch 26, 2021

Overview

Phase: Phase 1
Intervention: INCB099318
Conditions: Advanced Solid Tumors
Sponsor: Incyte Corporation
Enrollment: 105
Locations: 24
Primary Endpoint: Number of treatment-emergent adverse events
Status: Terminated
Last Updated: 6 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, and pharmacodynamics of INCB099318 in select solid tumors.

Registry

clinicaltrials.gov

Start Date

March 26, 2021

End Date

August 16, 2024

Last Updated

6 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Incyte Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment.
•Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered nonamenable to surgery or other curative treatments or procedures.
•ECOG performance status score of 0 or
•Life expectancy \> 12 weeks.
•Willingness to avoid pregnancy or fathering children.

Exclusion Criteria

•Exclusion Criteria:
•Laboratory values outside the Protocol-defined ranges.
•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 (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
•Known additional malignancy that is progressing or requires active treatment.
•Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (including prior IO) and/or complications from prior surgical intervention before starting study treatment.
•Prior receipt of an anti-PD-L1 therapy.
•Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
•A 28-day washout for systemic antibiotics is required.

Arms & Interventions

Cohort 1

Participants with select solid tumors who are immunotherapy treatment-naive

Intervention: INCB099318

Cohort 2

Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve.

Intervention: INCB099318

Cohort 3

Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy

Intervention: INCB099318

Outcomes

Primary Outcomes

Number of treatment-emergent adverse events

Time Frame: Up to approximately 25 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 up to 30 days after last dose of study drug.