A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Select Advanced Solid Tumors

Incyte Corporation21 sites in 5 countries182 target enrollmentSeptember 4, 2020

ConditionsAdvanced Solid Tumor MSI-H/dMMR Tumors Cutaneous Squamous Cell Carcinoma Urothelial Carcinoma Cervical Cancer HepatoCellular Carcinoma Esophageal Squamous Cell Carcinoma Merkel Cell Carcinoma Small-cell Lung Cancer Mesothelioma PD-L1 Amplified Tumor (9p24.1)Nasopharyngeal Carcinoma

InterventionsINCB099280

DrugsINCB099280

Overview

Phase: Phase 1
Intervention: INCB099280
Conditions: Advanced Solid Tumor
Sponsor: Incyte Corporation
Enrollment: 182
Locations: 21
Primary Endpoint: Number of treatment-emergent adverse events
Status: Completed
Last Updated: 9 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 INCB099280 in participants with select solid tumors

Registry

clinicaltrials.gov

Start Date

September 4, 2020

End Date

November 21, 2024

Last Updated

9 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.
•Eastern Cooperative Oncology Group performance status score of 0 or
•Life expectancy \> 12 weeks.
•Willingness to avoid pregnancy or fathering children.

Exclusion Criteria

•Laboratory values outside the Protocol-defined ranges.
•Clinically significant cardiac disease.
•History or presence of an electrocardiogram 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.
•Probiotic usage while on study and during screening is prohibited.

Arms & Interventions

Cohort 2

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

Intervention: INCB099280

Cohort 3

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

Intervention: INCB099280

Cohort 1

Participants with select solid tumors who are immunotherapy treatment-naive

Intervention: INCB099280

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.