A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive
NCT ID: NCT05879822
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
73 participants
INTERVENTIONAL
2023-10-30
2026-07-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1: INCB099280 Dose 1
Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years.
INCB099280
Administered as specified in the treatment arm description
Part 1: INCB099280 Dose 2
Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years.
INCB099280
Administered as specified in the treatment arm description
Part 1: INCB099280 Dose 3
Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years
INCB099280
Administered as specified in the treatment arm description
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.
INCB099280
Administered as specified in the treatment arm description
Interventions
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INCB099280
Administered as specified in the treatment arm description
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Incyte Medical Monitor
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Fundacao Pio Xii Hospital de Cancer de Barretos
Barretos, , Brazil
Cionc-Centro Integrado de Oncologia de Curitiba
Curitiba, , Brazil
Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Câncer
Curitiba, , Brazil
Oncosite - Centro de Pesquisa Clinica E Oncologia
Ijuí, , Brazil
Clinica de Neoplasias Litoral Ltda
Itajaí, , Brazil
Fundacao Doutor Amaral Carvalho
Jaú, , Brazil
Hospital de Cancer de Londrina
Londrina, , Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, , Brazil
Hgb - Hospital Giovanni Battista - Mae de Deus Center
Porto Alegre, , Brazil
Hospital Ernesto Dornelles
Porto Alegre, , Brazil
Hospital Nossa Senhora Da Conceicao
Porto Alegre, , Brazil
Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
Santo André, , Brazil
A. C. Camargo Cancer Center
São Paulo, , Brazil
The People'S Hospital of Guangxi Zhuang Autonomous Region
Nanning, , China
High Technology Hospital Medcenter
Batumi, , Georgia
Jsc Evex Hospitals
Kutaisi, , Georgia
Caucasus Medical Centre Llc
Tbilisi, , Georgia
Archangel St. Michael Multi Profile Clinical Hospital
Tbilisi, , Georgia
Israel-Georgian Medical Research Clinic Helsicore
Tbilisi, , Georgia
Todua Clinic, Llc
Tbilisi, , Georgia
New Hospitals
Tbilisi, , Georgia
Tim-Tbilisi Institute of Medicine Ltd
Tbilisi, , Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Llc
Tbilisi, , Georgia
Institute of Clinical Oncology Ltd
Tbilisi, , Georgia
Cancer Research Center Ltd
Tbilisi, , Georgia
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi, , Georgia
251 Air Force General Hospital
Athens, , Greece
University Hospital of West Attica - Attikon
Athens, , Greece
Euromedica General Clinic of Thessaloniki
Thessaloniki, , Greece
Semmelweis Egyetem
Budapest, , Hungary
Orszagos Onkologiai Intezet
Budapest, , Hungary
Dunedin Hospital
Dunedin, , New Zealand
Rotorua Hospital
Rotorua, , New Zealand
Centrul Medical Medicover Victoria
Bucharest, , Romania
Institutul Clinic Fundeni Clinica
Bucharest, , Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
Cluj-Napoca, , Romania
Spitalul Clinic Militar de Urgenta Dr. Constantin Papilian Cluj-Napoca
Cluj-Napoca, , Romania
Medisprof
Cluj-Napoca, , Romania
Centrul de Oncologie Sf. Nectarie Craiova
Craiova, , Romania
Sc Radiotherapy Center Cluj Srl
Floreşti, , Romania
Institutul Regional de Oncologie Iasi
Iași, , Romania
S.C. Medical Center Gral Srl
Ploieşti, , Romania
S C Oncocenter Oncologie Medicala S R L
Timișoara, , Romania
Oncomed Srl
Timișoara, , Romania
Cape Town Oncology Trials (Pty) Ltd
Cape Town, , South Africa
Johese Clinical Research: Midstream
Centurion, , South Africa
Wits Clinical Research
Johannesburg, , South Africa
The Medical Oncology Centre of Rosebank
Johannesburg, , South Africa
Phoenix Pharma (Pty) Ltd
Port Elizabeth, , South Africa
Medical Park Seyhan Hospital
Adana, , Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, , Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, , Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, , Turkey (Türkiye)
Countries
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Related Links
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A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive
Other Identifiers
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INCB 99280-211
Identifier Type: -
Identifier Source: org_study_id
2022-502716-37-00
Identifier Type: REGISTRY
Identifier Source: secondary_id