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

INTRODUCTION

  • Org Study ID: INCB 99280-112
  • Secondary ID: N/A
  • NTC ID: NCT04242199
  • Sponsor: Incyte Corporation

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

  • Overall Status
    Recruiting
  • Start Date
    August 20, 2020
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of treatment-emergent adverse events

Primary Outcome 1 - Timeframe: Up to approximately 25 months

CONDITION

  • 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

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Louis Viviers, MD

Role: Study Director

Affiliation: Incyte Corporation

Overall Contact

Name: Louis Viviers, MD

Phone: 1.855.463.3463, +800 00027423

Email: medinfo@incyte.com, globalmedinfo@incyte.com

LOCATION

Facility Status Contact
Facility: Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: N/A
Facility: Henry Ford Hospital
Detroit, Michigan 48202
United States
Status: Recruiting Contact: N/A
Facility: Upmc Cancercenter
Pittsburgh, Pennsylvania 15232
United States
Status: Recruiting Contact: N/A
Facility: University of Washington
Seattle, Washington 98195
United States
Status: Recruiting Contact: N/A
Facility: Chris Obrien Lifehouse
Camperdown, New South Wales 02050
Australia
Status: Recruiting Contact: N/A
Facility: Austin Hospital
Heidelberg, Victoria 03004
Australia
Status: Recruiting Contact: N/A
Facility: Linear Clinical Research
Nedlands, Western Australia 02650
Australia
Status: Recruiting Contact: N/A
Facility: Cliniques Universitaires Ucl Saint-Luc
Brussels, 09000
Belgium
Status: Recruiting Contact: N/A
Facility: Universitair Ziekenhuis Antwerpen (Uza)
Edegem, 03000
Belgium
Status: Recruiting Contact: N/A
Facility: Ghent University Hospital
Ghent, 3000
Belgium
Status: Recruiting Contact: N/A
Facility: Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven, 49933
Belgium
Status: Recruiting Contact: N/A
Facility: Institut Jules Bordet
Leuven, 33076
Belgium
Status: Recruiting Contact: N/A
Facility: Institut de Cancerologie de L Ouest - Site Paul Papin
Angers, 35042
France
Status: Recruiting Contact: N/A
Facility: Institut Bergonie
Bordeaux,
France
Status: Recruiting Contact: N/A
Facility: Centre Eugene Marquis
Rennes,
France
Status: Recruiting Contact: N/A