Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04242199
Other study ID # INCB 99280-112
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date September 4, 2020
Est. completion date October 31, 2025

Study information

Verified date May 2024
Source Incyte Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 182
Est. completion date October 31, 2025
Est. primary completion date July 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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.

Study Design


Intervention

Drug:
INCB099280
INCB099280 administered orally in 25 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle

Locations

Country Name City State
Australia Chris Obrien Lifehouse Camperdown New South Wales
Australia Austin Hospital Heidelberg Victoria
Australia Nucleus Network Pty Ltd Melbourne Victoria
Australia Linear Clinical Research Nedlands Western Australia
Belgium Cliniques Universitaires Ucl Saint-Luc Brussels
Belgium Institut Jules Bordet Clinical Trials Conduct Unit Brussels
Belgium Universitair Ziekenhuis Antwerpen (Uza) Edegem
Belgium Ghent University Hospital Ghent
Belgium Universitaire Ziekenhuis Leuven - Gasthuisberg Leuven
France Institut de Cancerologie de L Ouest - Site Paul Papin Angers
France Institut Bergonie Bordeaux
France Chu Hopital de La Timone Marseille Cedex 5
France Centre Eugene Marquis Rennes
France Institut Gustave Roussy Villejuif
Japan National Cancer Center Hospital East Chiba
Japan National Cancer Center Hospital Tokyo
United States Dana Farber Cancer Institute Boston Massachusetts
United States Henry Ford Hospital Detroit Michigan
United States Md Anderson Cancer Center Houston Texas
United States Upmc Cancercenter Pittsburgh Pennsylvania
United States University of Washington Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of treatment-emergent adverse events 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. Up to approximately 25 months
Secondary Cmax of INCB099280 Maximum observed plasma concentration Up to approximately 3 months
Secondary tmax of INCB099280 Time to maximum plasma concentration Up to approximately 3 months
Secondary Cmin of INCB099280 Minimum observed plasma concentration over the dose interval Up to approximately 3 months
Secondary AUC0-t of INCB099280 Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t Up to approximately 3 months
Secondary t½ of INCB099280 Apparent terminal-phase disposition half-life Up to approximately 3 months
Secondary ?z of INCB099280 Terminal elimination rate constant Up to approximately 3 months
Secondary CL/F of INCB099280 Oral dose clearance Up to approximately 3 months
Secondary Vz/F of INCB099280 Apparent oral dose volume of distribution Up to approximately 3 months
See also
  Status Clinical Trial Phase
Recruiting NCT04209491 - Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
Completed NCT03963206 - Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE) Phase 4
Completed NCT03268499 - TACE Emulsion Versus Suspension Phase 2
Recruiting NCT05044676 - Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
Recruiting NCT05263830 - Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy
Recruiting NCT05095519 - Hepatocellular Carcinoma Imaging Using PSMA PET/CT Phase 2
Recruiting NCT05497531 - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers N/A
Completed NCT05068193 - A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers Phase 1
Active, not recruiting NCT03781934 - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations Phase 1/Phase 2
Terminated NCT03655613 - APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC Phase 1/Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT04401800 - Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma Phase 2
Withdrawn NCT05418387 - A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona N/A
Active, not recruiting NCT04039607 - A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma Phase 3
Terminated NCT03970616 - A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma Phase 1/Phase 2
Recruiting NCT06239155 - A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03642561 - Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE Phase 2/Phase 3
Recruiting NCT04118114 - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors Phase 2
Completed NCT03222076 - Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer Phase 2
Recruiting NCT05537402 - LOcoregional vs Systemic Therapy in Patients With BCLC Stage B HCC Phase 2