Clinical trial NCT04242199: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
Official title: A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Select Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced 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
Keywords: Advanced Solid Tumor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2020-01-27
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study consists of 2 parts. Part 1 is a dose-escalation design to identify the maximum tolerant dose and/or pharmacologically active dose for INCB099280. Part 2 is an expansion at 1 or more dose levels to further explore safety, preliminary efficacy, pharmacokinetic, and pharmacodynamic effects.
Primary purpose: TREATMENT

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


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 1.
* 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.
* Active infection requiring systemic therapy.
* Known history of Human Immunodeficiency Virus (HIV)
* Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.

Primary outcomes:
measure: Number of treatment-emergent adverse events
timeFrame: Up to approximately 25 months
Secondary outcomes:
measure: Cmax of INCB099280
timeFrame: Up to approximately 3 months
measure: tmax of INCB099280
timeFrame: Up to approximately 3 months
measure: Cmin of INCB099280
timeFrame: Up to approximately 3 months
measure: AUC0-t of INCB099280
timeFrame: Up to approximately 3 months
measure: t½ of INCB099280
timeFrame: Up to approximately 3 months
measure: λz of INCB099280
timeFrame: Up to approximately 3 months
measure: CL/F of INCB099280
timeFrame: Up to approximately 3 months
measure: Vz/F of INCB099280
timeFrame: Up to approximately 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Pittsburgh
country: United States
facility: Upmc Cancercenter
state: Pennsylvania
city: Houston
country: United States
facility: Md Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Camperdown
country: Australia
facility: Chris Obrien Lifehouse
state: New South Wales
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Nucleus Network Pty Ltd
state: Victoria
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
city: Brussels
country: Belgium
facility: Cliniques Universitaires Ucl Saint-Luc
city: Brussels
country: Belgium
facility: Institut Jules Bordet Clinical Trials Conduct Unit
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen (Uza)
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuis Leuven - Gasthuisberg
city: Angers
country: France
facility: Institut de Cancerologie de L Ouest - Site Paul Papin
city: Bordeaux
country: France
facility: Institut Bergonie
city: Marseille Cedex 5
country: France
facility: Chu Hopital de La Timone
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Chiba
country: Japan
facility: National Cancer Center Hospital East
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References: