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

September 1, 2026 updated by: Incyte Corporation

A Phase 2 Study Evaluating INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Incyte Corporation Call Center (US)
  • Phone Number: 1.855.463.3463
  • Email: medinfo@incyte.com

Study Contact Backup

  • Name: Incyte Corporation Call Center (ex-US)
  • Phone Number: +800 00027423
  • Email: eumedinfo@incyte.com

Study Locations

  • Brazil
      • Barretos, Brazil, 14784-400
        • Fundacao Pio Xii Hospital de Cancer de Barretos
      • Curitiba, Brazil, 81520-060
        • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Cancer
      • Curitiba, Brazil, 80810-050
        • CIONC-Centro Integrado de Oncologia de Curitiba
      • Ijuí, Brazil, 98700-000
        • Oncosite - Centro de Pesquisa Clinica E Oncologia
      • Itajaí, Brazil, 88301-220
        • Clinica de Neoplasias Litoral Ltda
      • Jaú, Brazil, 17210-120
        • Fundacao Doutor Amaral Carvalho
      • Londrina, Brazil, 86015-520
        • Hospital de Cancer de Londrina
      • Porto Alegre, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao
      • Porto Alegre, Brazil, 90160-093
        • Hospital Ernesto Dornelles
      • Porto Alegre, Brazil, 90020-090
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
      • Porto Alegre, Brazil, 90110-270
        • Hgb - Hospital Giovanni Battista - Mae de Deus Center
      • Santo André, Brazil, 09060-870
        • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
      • São Paulo, Brazil, 01509-900
        • A. C. Camargo Cancer Center
  • China
      • Nanning, China, 530021
        • The People's Hospital of Guangxi Zhuang Autonomous Region
  • Georgia
      • Batumi, Georgia, 06004
        • High Technology Hospital Medcenter
      • Kutaisi, Georgia, 04600
        • Jsc Evex Hospitals
      • Tbilisi, Georgia, 00102
        • Archangel St. Michael Multi Profile Clinical Hospital
      • Tbilisi, Georgia, 00112
        • Israel-Georgian Medical Research Clinic Helsicore
      • Tbilisi, Georgia, 00114
        • New Hospitals
      • Tbilisi, Georgia, 00159
        • Institute of Clinical Oncology Ltd
      • Tbilisi, Georgia, 00177
        • Cancer Research Center Ltd
      • Tbilisi, Georgia, 00000
        • Caucasus Medical Centre Llc
      • Tbilisi, Georgia, 00112
        • Todua Clinic, Llc
      • Tbilisi, Georgia, 00141
        • Tim-Tbilisi Institute of Medicine Ltd
      • Tbilisi, Georgia, 00144
        • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Llc
      • Tbilisi, Georgia, 00186
        • Medulla Chemotherapy and Immunotherapy Clinic
  • Greece
      • Athens, Greece, 12462
        • University Hospital of West Attica - Attikon
      • Athens, Greece, 115 25
        • 251 Air Force General Hospital
      • Thessaloniki, Greece, 54645
        • Euromedica General Clinic of Thessaloniki
  • Hungary
      • Budapest, Hungary, 01083
        • Semmelweis Egyetem
      • Budapest, Hungary, 01122
        • Országos Onkológiai Intézet
  • New Zealand
      • Dunedin, New Zealand, 09016
        • Dunedin Hospital
      • Rotorua, New Zealand, 03010
        • Rotorua Hospital
  • Romania
      • Bucharest, Romania, 10626
        • Centrul Medical Medicover Victoria
      • Bucharest, Romania, 22328
        • Institutul Clinic Fundeni Clinica
      • Cluj-Napoca, Romania, 400641
        • Medisprof
      • Cluj-Napoca, Romania, 400015
        • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
      • Cluj-Napoca, Romania, 400132
        • Spitalul Clinic Militar de Urgenta Dr. Constantin Papilian Cluj-Napoca
      • Craiova, Romania, 200347
        • Centrul de Oncologie Sf. Nectarie Craiova
      • Floreşti, Romania, 407280
        • SC Radiotherapy Center Cluj SRL
      • Iași, Romania, 700483
        • Institutul Regional de Oncologie Iasi
      • Ploieşti, Romania, 100337
        • S.C. Medical Center Gral Srl
      • Timișoara, Romania, 300239
        • Oncomed SRL
      • Timișoara, Romania, 300166
        • S C Oncocenter Oncologie Medicala S R L
  • South Africa
      • Cape Town, South Africa, 07570
        • Cape Town Oncology Trials (Pty) Ltd
      • Centurion, South Africa, 01692
        • Johese Clinical Research: Midstream
      • Johannesburg, South Africa, 02193
        • Wits Clinical Research
      • Johannesburg, South Africa, 02196
        • The Medical Oncology Centre of Rosebank
      • Port Elizabeth, South Africa, 06001
        • Phoenix Pharma (Pty) Ltd
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01140
        • Medical Park Seyhan Hospital
      • Ankara, Turkey (Türkiye), 06100
        • Hacettepe University Medical Faculty
      • Edirne, Turkey (Türkiye), 22030
        • Trakya University Medical Faculty
      • Istanbul, Turkey (Türkiye), 34093
        • Goztepe Prof. Dr. Suleyman Yalcin City Hospital
      • Kocaeli, Turkey (Türkiye), 41380
        • Kocaeli Universitesi Tip Fakultesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1: INCB099280 Dose 1
Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years.
Drug: INCB099280
Administered as specified in the treatment arm description
Experimental: Part 1: INCB099280 Dose 2
Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years.
Drug: INCB099280
Administered as specified in the treatment arm description
Experimental: Part 1: INCB099280 Dose 3
Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years
Drug: INCB099280
Administered as specified in the treatment arm description
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.
Drug: INCB099280
Administered as specified in the treatment arm description

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Up to 2 years
Defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as determined by investigator radiographic disease assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Up to 2 years
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to 2 years 3 months
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 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurs first.
Up to 2 years 3 months
Number of participants with TEAEs leading to dose modification or discontinuation
Time Frame: Up to 2 years
Number of participants with TEAEs leading to dose modification or discontinuation.
Up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR)
Time Frame: Up to 2 years
Defined as the percentage of participants with the best overall response of CR or PR, or stable disease (SD), after a minimum of 15 weeks following the initiation of study treatment by investigator assessment per RECIST v1.1.
Up to 2 years
Duration Of Response (DOR)
Time Frame: Up to 2 years
Defined as the time from the earliest date of CR or PR until the earliest date of disease progression, as determined by investigator radiographic disease assessment according to RECIST v1.1, or death due to any cause if occurring sooner than progression.
Up to 2 years
INCB099280 pharmacokinetic (PK) in Plasma
Time Frame: Pre dose and 1, 2 and 6 hours post dose on Cycle 1 Day 1 and Cycle 2 Day 1. Pre dose every other cycle until Cycle 11 Day 1 (Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1 and Cycle 11 Day 1) (each cycle is 28 days)
INCB099280 concentration in plasma
Pre dose and 1, 2 and 6 hours post dose on Cycle 1 Day 1 and Cycle 2 Day 1. Pre dose every other cycle until Cycle 11 Day 1 (Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1 and Cycle 11 Day 1) (each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Incyte Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Incyte Medical Monitor, Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INCB 99280-211
  • 2022-502716-37-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

IPD Sharing Time Frame

Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

IPD Sharing Access Criteria

Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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