Advanced Solid TumorPhase 2NCT05879822
A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive
A Phase 2 study testing INCB099280 in people with Advanced Solid Tumor, run by Incyte Corporation at 54 sites in 9 countries.
Trial summary
This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- INCB099280
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 54 sitesin 9 countries
- Study dates
- 30 Oct 2023to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 locations and contacts
54 sites in 9 countries.
54 sites in 9 countries
Brazil13 sites
Fundacao Pio Xii Hospital de Cancer de Barretos
Barretos, 14784-400
Cionc-Centro Integrado de Oncologia de Curitiba
Curitiba, 80810-050
Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Câncer
Curitiba, 81520-060
Oncosite - Centro de Pesquisa Clinica E Oncologia
Ijuí, 98700-000
Clinica de Neoplasias Litoral Ltda
Itajaí, 88301-220
Fundacao Doutor Amaral Carvalho
Jaú, 17210-120
Hospital de Cancer de Londrina
Londrina, 86015-520
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90020-090
Hgb - Hospital Giovanni Battista - Mae de Deus Center
Porto Alegre, 90110-270
Hospital Ernesto Dornelles
Porto Alegre, 90160-093
Hospital Nossa Senhora Da Conceicao
Porto Alegre, 91350-200
Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
Santo André, 09060-870
A. C. Camargo Cancer Center
São Paulo, 01509-900
Georgia12 sites
High Technology Hospital Medcenter
Batumi, 06004
Jsc Evex Hospitals
Kutaisi, 04600
Caucasus Medical Centre Llc
Tbilisi, 00000
Archangel St. Michael Multi Profile Clinical Hospital
Tbilisi, 00102
Israel-Georgian Medical Research Clinic Helsicore
Tbilisi, 00112
Todua Clinic, Llc
Tbilisi, 00112
New Hospitals
Tbilisi, 00114
Tim-Tbilisi Institute of Medicine Ltd
Tbilisi, 00141
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Llc
Tbilisi, 00144
Institute of Clinical Oncology Ltd
Tbilisi, 00159
Cancer Research Center Ltd
Tbilisi, 00177
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi, 00186
Romania11 sites
Centrul Medical Medicover Victoria
Bucharest, 10626
Institutul Clinic Fundeni Clinica
Bucharest, 22328
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
Cluj-Napoca, 400015
Spitalul Clinic Militar de Urgenta Dr. Constantin Papilian Cluj-Napoca
Cluj-Napoca, 400132
Medisprof
Cluj-Napoca, 400641
Centrul de Oncologie Sf. Nectarie Craiova
Craiova, 200347
Sc Radiotherapy Center Cluj Srl
Floreşti, 407280
Institutul Regional de Oncologie Iasi
Iași, 700483
S.C. Medical Center Gral Srl
Ploieşti, 100337
S C Oncocenter Oncologie Medicala S R L
Timișoara, 300166
Oncomed Srl
Timișoara, 300239
South Africa5 sites
Cape Town Oncology Trials (Pty) Ltd
Cape Town, 07570
Johese Clinical Research: Midstream
Centurion, 01692
Wits Clinical Research
Johannesburg, 02193
The Medical Oncology Centre of Rosebank
Johannesburg, 02196
Phoenix Pharma (Pty) Ltd
Port Elizabeth, 06001
Turkey (Türkiye)5 sites
Medical Park Seyhan Hospital
Adana, 01140
Hacettepe University Medical Faculty
Ankara, 06100
Trakya University Medical Faculty
Edirne, 22030
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, 34093
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380
Greece3 sites
251 Air Force General Hospital
Athens, 115 25
University Hospital of West Attica - Attikon
Athens, 12462
Euromedica General Clinic of Thessaloniki
Thessaloniki, 54645
Hungary2 sites
Semmelweis Egyetem
Budapest, 01083
Orszagos Onkologiai Intezet
Budapest, 01122
New Zealand2 sites
Dunedin Hospital
Dunedin, 09016
Rotorua Hospital
Rotorua, 03010
China1 site
The People'S Hospital of Guangxi Zhuang Autonomous Region
Nanning, 530021
About this study
Official title: 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- INCB099280
- Keywords
- Advanced Solid Tumor, Hepatocellular Carcinoma, Cutaneous Melanoma, PD-L1-positive NSCLC, Non-small Cell Lung Cancer, Renal Cell Carcinoma, Urothelial Cancer, MSI-H/dMMR Tumors
- Medical subject headings
- Carcinoma, Hepatocellular, Melanoma, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB099280Drug
Administered as specified in the treatment arm description
| Study group | Role | What they receive |
|---|---|---|
| Part 1: INCB099280 Dose 1 | Experimental | Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years. Receives: Drug: INCB099280 |
| Part 1: INCB099280 Dose 2 | Experimental | Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years. Receives: Drug: INCB099280 |
| Part 1: INCB099280 Dose 3 | Experimental | Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years Receives: Drug: INCB099280 |
| Part 2: INCB099280 Dose selected from Part 1 | Experimental | Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years. Receives: Drug: INCB099280 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
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.
Measured: Up to 2 years
Number of participants with Treatment-emergent Adverse Events (TEAEs)
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.
Measured: Up to 2 years 3 months
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with TEAEs leading to dose modification or discontinuation.
Measured: Up to 2 years
Secondary outcomes (3)
Disease Control Rate (DCR)
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.
Measured: Up to 2 years
Duration Of Response (DOR)
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.
Measured: Up to 2 years
INCB099280 pharmacokinetic (PK) in Plasma
INCB099280 concentration in plasma
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start30 Oct 2023
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Why it stopped: This was a strategic business decision. There were no safety concerns contributing to this decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of 2 parts. In Part 1, participants with 6 different tumor types will be randomized 1:1:1 to INCB099280 Dose 1, INCB099280 Dose 2, or INCB099280 Dose 3 twice daily (BID). At the end of Part 1, an integrated analysis will be performed to select a dose. Once a dose is selected, Part 2 will proceed to complete enrollment for each of the 6 disease-specific cohorts at the selected dose.
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879822
- Sponsor's protocol ID
- INCB 99280-211
- Other IDs
- 2022-502716-37-00
- Status last verified
- Oct 2026
- First submitted
- 19 May 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study Evaluating INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive
- ClinicalTrials.gov ID
- NCT05879822
- Acronym / sponsor ID
- INCB 99280-211
- Conditions
- Advanced Solid Tumor
- Keywords
- Advanced Solid Tumor, Hepatocellular Carcinoma, Cutaneous Melanoma, PD-L1-positive NSCLC, Non-small Cell Lung Cancer, Renal Cell Carcinoma, Urothelial Cancer, MSI-H/dMMR Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This was a strategic business decision. There were no safety concerns contributing to this decision.
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study consists of 2 parts. In Part 1, participants with 6 different tumor types will be randomized 1:1:1 to INCB099280 Dose 1, INCB099280 Dose 2, or INCB099280 Dose 3 twice daily (BID). At the end of Part 1, an integrated analysis will be performed to select a dose. Once a dose is selected, Part 2 will proceed to complete enrollment for each of the 6 disease-specific cohorts at the selected dose.
| Arm | Type | Receives |
|---|---|---|
| Part 1: INCB099280 Dose 1 | Experimental | Drug: INCB099280Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years. |
| Part 1: INCB099280 Dose 2 | Experimental | Drug: INCB099280Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years. |
| Part 1: INCB099280 Dose 3 | Experimental | Drug: INCB099280Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years |
| Part 2: INCB099280 Dose selected from Part 1 | Experimental | Drug: INCB099280Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Life expectancy > 3 months.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCB099280Administered as specified in the treatment arm description | Drug | Part 1: INCB099280 Dose 1, Part 1: INCB099280 Dose 2, Part 1: INCB099280 Dose 3, Part 2: INCB099280 Dose selected from Part 1 |
Primary outcome
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.
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.
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.
3 secondary outcomes
Disease Control Rate (DCR)
Time frame: Up to 2 years
Duration Of Response (DOR)
Time frame: 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)
Results and safety
The study was stopped early (reason given: This was a strategic business decision. There were no safety concerns contributing to this decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor NaiveLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Incyte Medical Monitor study director
Incyte Corporation
54 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INCB099280 in people with Advanced Solid Tumor, run by Incyte Corporation at 54 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Brazil, Georgia, Romania, South Africa, Turkey (Türkiye) and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This was a strategic business decision. There were no safety concerns contributing to this decision.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.