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New hope for advanced tumors: drug trial targets untreated patients

NCT ID NCT05879822

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This study tests a new drug called INCB099280 in 73 people with advanced solid tumors who have not received immunotherapy before. The goal is to see if the drug can shrink tumors and to check for side effects. The study focuses on safety and how well the drug works in the short term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

73 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma hepatocellular carcinoma melanoma non-small cell lung carcinoma nonpapillary renal cell carcinoma renal cell carcinoma urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor

Contacts and locations

Locations

  • 251 Air Force General Hospital

    Athens, 115 25, Greece

  • A. C. Camargo Cancer Center

    São Paulo, 01509-900, Brazil

  • Archangel St. Michael Multi Profile Clinical Hospital

    Tbilisi, 00102, Georgia

  • Cancer Research Center Ltd

    Tbilisi, 00177, Georgia

  • Cape Town Oncology Trials (Pty) Ltd

    Cape Town, 07570, South Africa

  • Caucasus Medical Centre Llc

    Tbilisi, 00000, Georgia

  • Centrul Medical Medicover Victoria

    Bucharest, 10626, Romania

  • Centrul de Oncologie Sf. Nectarie Craiova

    Craiova, 200347, Romania

  • Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia

    Santo André, 09060-870, Brazil

  • Cionc-Centro Integrado de Oncologia de Curitiba

    Curitiba, 80810-050, Brazil

  • Clinica de Neoplasias Litoral Ltda

    Itajaí, 88301-220, Brazil

  • Dunedin Hospital

    Dunedin, 09016, New Zealand

  • Euromedica General Clinic of Thessaloniki

    Thessaloniki, 54645, Greece

  • Fundacao Doutor Amaral Carvalho

    Jaú, 17210-120, Brazil

  • Fundacao Pio Xii Hospital de Cancer de Barretos

    Barretos, 14784-400, Brazil

  • Goztepe Prof. Dr. Suleyman Yalcin City Hospital

    Istanbul, 34093, Turkey (Türkiye)

  • Hacettepe University Medical Faculty

    Ankara, 06100, Turkey (Türkiye)

  • Hgb - Hospital Giovanni Battista - Mae de Deus Center

    Porto Alegre, 90110-270, Brazil

  • High Technology Hospital Medcenter

    Batumi, 06004, Georgia

  • Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Câncer

    Curitiba, 81520-060, Brazil

  • Hospital Ernesto Dornelles

    Porto Alegre, 90160-093, Brazil

  • Hospital Nossa Senhora Da Conceicao

    Porto Alegre, 91350-200, Brazil

  • Hospital de Cancer de Londrina

    Londrina, 86015-520, Brazil

  • Institute of Clinical Oncology Ltd

    Tbilisi, 00159, Georgia

  • Institutul Clinic Fundeni Clinica

    Bucharest, 22328, Romania

  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

    Cluj-Napoca, 400015, Romania

  • Institutul Regional de Oncologie Iasi

    Iași, 700483, Romania

  • Irmandade Da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090, Brazil

  • Israel-Georgian Medical Research Clinic Helsicore

    Tbilisi, 00112, Georgia

  • Johese Clinical Research: Midstream

    Centurion, 01692, South Africa

  • Jsc Evex Hospitals

    Kutaisi, 04600, Georgia

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380, Turkey (Türkiye)

  • Medical Park Seyhan Hospital

    Adana, 01140, Turkey (Türkiye)

  • Medisprof

    Cluj-Napoca, 400641, Romania

  • Medulla Chemotherapy and Immunotherapy Clinic

    Tbilisi, 00186, Georgia

  • New Hospitals

    Tbilisi, 00114, Georgia

  • Oncomed Srl

    Timișoara, 300239, Romania

  • Oncosite - Centro de Pesquisa Clinica E Oncologia

    Ijuí, 98700-000, Brazil

  • Orszagos Onkologiai Intezet

    Budapest, 01122, Hungary

  • Phoenix Pharma (Pty) Ltd

    Port Elizabeth, 06001, South Africa

  • Rotorua Hospital

    Rotorua, 03010, New Zealand

  • S C Oncocenter Oncologie Medicala S R L

    Timișoara, 300166, Romania

  • S.C. Medical Center Gral Srl

    Ploieşti, 100337, Romania

  • Sc Radiotherapy Center Cluj Srl

    Floreşti, 407280, Romania

  • Semmelweis Egyetem

    Budapest, 01083, Hungary

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

    Cluj-Napoca, 400132, Romania

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

    Tbilisi, 00144, Georgia

  • The Medical Oncology Centre of Rosebank

    Johannesburg, 02196, South Africa

  • The People'S Hospital of Guangxi Zhuang Autonomous Region

    Nanning, 530021, China

  • Tim-Tbilisi Institute of Medicine Ltd

    Tbilisi, 00141, Georgia

  • Todua Clinic, Llc

    Tbilisi, 00112, Georgia

  • Trakya University Medical Faculty

    Edirne, 22030, Turkey (Türkiye)

  • University Hospital of West Attica - Attikon

    Athens, 12462, Greece

  • Wits Clinical Research

    Johannesburg, 02193, South Africa

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Other studies related to the condition(s) this trial covers.