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Clinical Trial Finder

Search Results

A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive

Study Purpose

This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced solid tumors.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Immunotherapy naive and without access to approved and/or available immune checkpoint inhibitor (ICI) therapy.
  • - Measurable disease per RECIST v1.1.
  • - One of the following disease settings: - Unresectable or metastatic Child-Pugh Class A hepatocellular carcinoma (HCC) not eligible for surgical and/or locoregional therapy and have not received prior systemic therapy or had disease progression following primary therapy.
  • - Unresectable or metastatic cutaneous melanoma and have not received more than 1 previous systemic therapy for advanced disease.
  • - Unresectable Stage III PD-L1-positive (TPS ≥ 50% using the Dako PD-L1 IHC 22C3 assay) non-small cell lung cancer (NSCLC) without actionable molecular biomarkers and have not received prior systemic therapy and where chemoradiation is contraindicated; in addition, able to provide fresh or archival tumor tissue for central confirmation of PD-L1 expression.
  • - Stage IV PD-L1-positive (TPS ≥ 50% using the Dako PD-L1 IHC 22C3 assay) NSCLC without actionable molecular biomarkers and have not received prior systemic therapy; in addition, able to provide fresh or archival tumor tissue for central confirmation of PD-L1 expression.
  • - Relapsed or Stage IV clear cell renal cell carcinoma (RCC) after having received 1 prior systemic therapy for relapsed or Stage IV disease.
  • - Cisplatin-ineligible, locally advanced or Stage IV urothelial cancer (UC) and have not received prior systemic therapy for locally advanced or Stage IV UC and able to provide fresh or archival tumor tissue for central confirmation of PD-L1 expression using the Dako PD-L1 IHC 22C3 assay.
  • - Advanced or metastatic microsatellite instability high (MSI-H) or deficient mismatch repair (dMMR) (as determined by an approved assay) solid tumors and able to provide fresh or archival tumor tissue for central confirmation of MSI-H or dMMR.
  • - Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • - Life expectancy > 3 months.
  • - Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

  • - Known history of an additional malignancy.
  • - Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease.
  • - Toxicity from prior therapy that has not recovered.
  • - Prior receipt of an PD-1, anti-PD-L1, or anti-PD-L2 agent or treatment with an immune modulator (eg, CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL-2, 4-1BB, CAR-T cell).
  • - Received thoracic radiation within 6 months of the first dose of study treatment.
  • - Participation in another interventional clinical study while receiving INCB099280.
  • - Impaired cardiac function or clinically significant cardiac disease.
  • - History or evidence of interstitial lung disease including noninfectious pneumonitis.
  • - Presence of gastrointestinal conditions that may affect drug absorption.
  • - Any autoimmune disease requiring systemic treatment in the past 5 years.
  • - Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent.
  • - Active infection requiring systemic therapy.
  • - History of organ transplantation, including allogeneic stem cell transplantation.
  • - Receipt of systemic antibiotics within 28 days of first dose of study treatment.
  • - Probiotic usage is prohibited during screening and throughout the study treatment period.
  • - Received a live vaccine within 28 days of the planned start of study drug.
  • - Laboratory values outside the Protocol-defined ranges.
Other protocol-defined Inclusion/Exclusion Criteria may apply.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05879822
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Incyte Corporation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Incyte Medical Monitor
Principal Investigator Affiliation Incyte Corporation
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Brazil, China, Georgia, Greece, Hungary, New Zealand, Romania, South Africa, Turkey (Türkiye)
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Advanced Solid Tumor
Arms & Interventions

Arms

Experimental: Part 1: INCB099280 Dose 1

Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years.

Experimental: Part 1: INCB099280 Dose 2

Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years.

Experimental: Part 1: INCB099280 Dose 3

Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years

Experimental: Part 2: INCB099280 Dose selected from Part 1

Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years.

Interventions

Drug: - INCB099280

Administered as specified in the treatment arm description

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Barretos 3470451, Brazil

Status

Address

Fundacao Pio Xii Hospital de Cancer de Barretos

Barretos 3470451, , 14784-400

Curitiba 3464975, Brazil

Status

Address

Cionc-Centro Integrado de Oncologia de Curitiba

Curitiba 3464975, , 80810-050

Curitiba 3464975, Brazil

Status

Address

Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Câncer

Curitiba 3464975, , 81520-060

Ijuí 3461444, Brazil

Status

Address

Oncosite - Centro de Pesquisa Clinica E Oncologia

Ijuí 3461444, , 98700-000

Clinica de Neoplasias Litoral Ltda, Itajaí 3460845, Brazil

Status

Address

Clinica de Neoplasias Litoral Ltda

Itajaí 3460845, , 88301-220

Fundacao Doutor Amaral Carvalho, Jaú 3460005, Brazil

Status

Address

Fundacao Doutor Amaral Carvalho

Jaú 3460005, , 17210-120

Hospital de Cancer de Londrina, Londrina 3458449, Brazil

Status

Address

Hospital de Cancer de Londrina

Londrina 3458449, , 86015-520

Porto Alegre 3452925, Brazil

Status

Address

Irmandade Da Santa Casa de Misericordia de Porto Alegre

Porto Alegre 3452925, , 90020-090

Porto Alegre 3452925, Brazil

Status

Address

Hgb - Hospital Giovanni Battista - Mae de Deus Center

Porto Alegre 3452925, , 90110-270

Hospital Ernesto Dornelles, Porto Alegre 3452925, Brazil

Status

Address

Hospital Ernesto Dornelles

Porto Alegre 3452925, , 90160-093

Hospital Nossa Senhora Da Conceicao, Porto Alegre 3452925, Brazil

Status

Address

Hospital Nossa Senhora Da Conceicao

Porto Alegre 3452925, , 91350-200

Santo André 3449701, Brazil

Status

Address

Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia

Santo André 3449701, , 09060-870

A. C. Camargo Cancer Center, São Paulo 3448439, Brazil

Status

Address

A. C. Camargo Cancer Center

São Paulo 3448439, , 01509-900

Nanning 1799869, China

Status

Address

The People'S Hospital of Guangxi Zhuang Autonomous Region

Nanning 1799869, , 530021

High Technology Hospital Medcenter, Batumi 615532, Georgia

Status

Address

High Technology Hospital Medcenter

Batumi 615532, , 06004

Jsc Evex Hospitals, Kutaisi 613607, Georgia

Status

Address

Jsc Evex Hospitals

Kutaisi 613607, , 04600

Caucasus Medical Centre Llc, Tbilisi 611717, Georgia

Status

Address

Caucasus Medical Centre Llc

Tbilisi 611717, , 00000

Tbilisi 611717, Georgia

Status

Address

Archangel St. Michael Multi Profile Clinical Hospital

Tbilisi 611717, , 00102

Tbilisi 611717, Georgia

Status

Address

Israel-Georgian Medical Research Clinic Helsicore

Tbilisi 611717, , 00112

Todua Clinic, Llc, Tbilisi 611717, Georgia

Status

Address

Todua Clinic, Llc

Tbilisi 611717, , 00112

New Hospitals, Tbilisi 611717, Georgia

Status

Address

New Hospitals

Tbilisi 611717, , 00114

Tim-Tbilisi Institute of Medicine Ltd, Tbilisi 611717, Georgia

Status

Address

Tim-Tbilisi Institute of Medicine Ltd

Tbilisi 611717, , 00141

Tbilisi 611717, Georgia

Status

Address

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Llc

Tbilisi 611717, , 00144

Institute of Clinical Oncology Ltd, Tbilisi 611717, Georgia

Status

Address

Institute of Clinical Oncology Ltd

Tbilisi 611717, , 00159

Cancer Research Center Ltd, Tbilisi 611717, Georgia

Status

Address

Cancer Research Center Ltd

Tbilisi 611717, , 00177

Tbilisi 611717, Georgia

Status

Address

Medulla Chemotherapy and Immunotherapy Clinic

Tbilisi 611717, , 00186

251 Air Force General Hospital, Athens 264371, Greece

Status

Address

251 Air Force General Hospital

Athens 264371, , 115 25

Athens 264371, Greece

Status

Address

University Hospital of West Attica - Attikon

Athens 264371, , 12462

Thessaloniki 734077, Greece

Status

Address

Euromedica General Clinic of Thessaloniki

Thessaloniki 734077, , 54645

Semmelweis Egyetem, Budapest 3054643, Hungary

Status

Address

Semmelweis Egyetem

Budapest 3054643, , 01083

Orszagos Onkologiai Intezet, Budapest 3054643, Hungary

Status

Address

Orszagos Onkologiai Intezet

Budapest 3054643, , 01122

Dunedin Hospital, Dunedin 2191562, New Zealand

Status

Address

Dunedin Hospital

Dunedin 2191562, , 09016

Rotorua Hospital, Rotorua 6241325, New Zealand

Status

Address

Rotorua Hospital

Rotorua 6241325, , 03010

Centrul Medical Medicover Victoria, Bucharest 683506, Romania

Status

Address

Centrul Medical Medicover Victoria

Bucharest 683506, , 10626

Institutul Clinic Fundeni Clinica, Bucharest 683506, Romania

Status

Address

Institutul Clinic Fundeni Clinica

Bucharest 683506, , 22328

Cluj-Napoca 681290, Romania

Status

Address

Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

Cluj-Napoca 681290, , 400015

Cluj-Napoca 681290, Romania

Status

Address

Spitalul Clinic Militar de Urgenta Dr. Constantin Papilian Cluj-Napoca

Cluj-Napoca 681290, , 400132

Medisprof, Cluj-Napoca 681290, Romania

Status

Address

Medisprof

Cluj-Napoca 681290, , 400641

Craiova 680332, Romania

Status

Address

Centrul de Oncologie Sf. Nectarie Craiova

Craiova 680332, , 200347

Sc Radiotherapy Center Cluj Srl, Floreşti 678063, Romania

Status

Address

Sc Radiotherapy Center Cluj Srl

Floreşti 678063, , 407280

Institutul Regional de Oncologie Iasi, Iași 675810, Romania

Status

Address

Institutul Regional de Oncologie Iasi

Iași 675810, , 700483

S.C. Medical Center Gral Srl, Ploieşti 670474, Romania

Status

Address

S.C. Medical Center Gral Srl

Ploieşti 670474, , 100337

S C Oncocenter Oncologie Medicala S R L, Timișoara 665087, Romania

Status

Address

S C Oncocenter Oncologie Medicala S R L

Timișoara 665087, , 300166

Oncomed Srl, Timișoara 665087, Romania

Status

Address

Oncomed Srl

Timișoara 665087, , 300239

Cape Town Oncology Trials (Pty) Ltd, Cape Town 3369157, South Africa

Status

Address

Cape Town Oncology Trials (Pty) Ltd

Cape Town 3369157, , 07570

Johese Clinical Research: Midstream, Centurion 1105777, South Africa

Status

Address

Johese Clinical Research: Midstream

Centurion 1105777, , 01692

Wits Clinical Research, Johannesburg 993800, South Africa

Status

Address

Wits Clinical Research

Johannesburg 993800, , 02193

The Medical Oncology Centre of Rosebank, Johannesburg 993800, South Africa

Status

Address

The Medical Oncology Centre of Rosebank

Johannesburg 993800, , 02196

Phoenix Pharma (Pty) Ltd, Port Elizabeth 964420, South Africa

Status

Address

Phoenix Pharma (Pty) Ltd

Port Elizabeth 964420, , 06001

Medical Park Seyhan Hospital, Adana 325363, Turkey (Türkiye)

Status

Address

Medical Park Seyhan Hospital

Adana 325363, , 01140

Hacettepe University Medical Faculty, Ankara 323786, Turkey (Türkiye)

Status

Address

Hacettepe University Medical Faculty

Ankara 323786, , 06100

Trakya University Medical Faculty, Edirne 747712, Turkey (Türkiye)

Status

Address

Trakya University Medical Faculty

Edirne 747712, , 22030

Istanbul 745044, Turkey (Türkiye)

Status

Address

Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul 745044, , 34093

Kocaeli Universitesi Tip Fakultesi, Kocaeli 306970, Turkey (Türkiye)

Status

Address

Kocaeli Universitesi Tip Fakultesi

Kocaeli 306970, , 41380

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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