Advanced Solid TumorPhase 1NCT04242199
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
A Phase 1 study testing INCB099280 in people with Advanced Solid Tumor and MSI-H/dMMR Tumors, run by Incyte Corporation at 21 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, MSI-H/dMMR Tumors, Cutaneous Squamous Cell Carcinoma
- What is being tested?
- INCB099280
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 21 sitesin 5 countries
- Study dates
- 4 Sep 2020to 21 Nov 2024
- Phase
- Phase 1
- 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
- Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment.
- Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered nonamenable to surgery or other curative treatments or procedures.
- Eastern Cooperative Oncology Group performance status score of 0 or 1.
- Life expectancy > 12 weeks.
- Willingness to avoid pregnancy or fathering children.
Who cannot join
- Laboratory values outside the Protocol-defined ranges.
- Clinically significant cardiac disease.
- History or presence of an electrocardiogram that, in the investigator's opinion, is clinically meaningful.
- Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
- Known additional malignancy that is progressing or requires active treatment.
- Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (including prior IO) and/or complications from prior surgical intervention before starting study treatment.
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- Prior receipt of an anti-PD-L1 therapy.
- Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
- A 28-day washout for systemic antibiotics is required.
- Probiotic usage while on study and during screening is prohibited.
- Active infection requiring systemic therapy.
- Known history of Human Immunodeficiency Virus (HIV)
- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
United States5 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Henry Ford Hospital
Detroit, Michigan, 48202
Md Anderson Cancer Center
Houston, Texas, 77030
Upmc Cancercenter
Pittsburgh, Pennsylvania, 15232
University of Washington
Seattle, Washington, 98195
Belgium5 sites
Cliniques Universitaires Ucl Saint-Luc
Brussels, 01200
Institut Jules Bordet Clinical Trials Conduct Unit
Brussels, B-1070
Universitair Ziekenhuis Antwerpen (Uza)
Edegem, 02650
Ghent University Hospital
Ghent, 09000
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven, 03000
France5 sites
Institut de Cancerologie de L Ouest - Site Paul Papin
Angers, 49000
Institut Bergonie
Bordeaux, 33076
Chu Hopital de La Timone
Marseille, 13385
Centre Eugene Marquis
Rennes, 35042
Institut Gustave Roussy
Villejuif, 94800
Australia4 sites
Chris Obrien Lifehouse
Camperdown, New South Wales, 02050
Austin Hospital
Heidelberg, Victoria, 03084
Nucleus Network Pty Ltd
Melbourne, Victoria, 03004
Linear Clinical Research
Nedlands, Western Australia, 06009
Japan2 sites
National Cancer Center Hospital East
Chiba, 277-8577
National Cancer Center Hospital
Tokyo, 104-0045
About this study
Official title: A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Select Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid tumors
- Conditions
- Advanced Solid Tumor, MSI-H/dMMR Tumors, Cutaneous Squamous Cell Carcinoma, Urothelial Carcinoma, Cervical Cancer, HepatoCellular Carcinoma
- Being tested
- INCB099280
- Keywords
- Advanced Solid Tumor
- Medical subject headings
- Carcinoma, Transitional Cell, Uterine Cervical Neoplasms, Carcinoma, Hepatocellular, Esophageal Squamous Cell Carcinoma, Carcinoma, Merkel Cell, Small Cell Lung Carcinoma, Mesothelioma, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB099280Drug
INCB099280 administered orally in 25 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants with select solid tumors who are immunotherapy treatment-naive Receives: Drug: INCB099280 |
| Cohort 2 | Experimental | Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve. Receives: Drug: INCB099280 |
| Cohort 3 | Experimental | Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy Receives: Drug: INCB099280 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-emergent adverse events
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 30 days after last dose of study drug.
Measured: Up to approximately 25 months
Secondary outcomes (8)
Cmax of INCB099280
Maximum observed plasma concentration
Measured: Up to approximately 3 months
tmax of INCB099280
Time to maximum plasma concentration
Measured: Up to approximately 3 months
Cmin of INCB099280
Minimum observed plasma concentration over the dose interval
Measured: Up to approximately 3 months
AUC0-t of INCB099280
Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t
Measured: Up to approximately 3 months
t½ of INCB099280
Apparent terminal-phase disposition half-life
Measured: Up to approximately 3 months
λz of INCB099280
Terminal elimination rate constant
Measured: Up to approximately 3 months
CL/F of INCB099280
Oral dose clearance
Measured: Up to approximately 3 months
Vz/F of INCB099280
Apparent oral dose volume of distribution
Measured: Up to approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start4 Sep 2020
- Primary completion29 Aug 2024
- Study completion21 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of 2 parts. Part 1 is a dose-escalation design to identify the maximum tolerant dose and/or pharmacologically active dose for INCB099280. Part 2 is an expansion at 1 or more dose levels to further explore safety, preliminary efficacy, pharmacokinetic, and pharmacodynamic effects.
- Masking
- None (open label)
- Enrolment
- 182 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
- NCT04242199
- Sponsor's protocol ID
- INCB 99280-112
- Other IDs
- 2019-004967-35, 2019
- Status last verified
- Jul 2025
- First submitted
- 23 Jan 2020
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share data
Publications
Prenen H, Rottey S, Pinato DJ, Lesimple T, Van Cutsem E, Robert M, Galot R, Piha-Paul SA, Tomasini P, Kotecki N, Kristeleit R, Le Tourneau C, Plummer R, Banerji U, Meniawy T, Howe J, Daniel J, Pulini J, Spitz S, Gong X, Halloran M, Italiano A. Phase I safety, efficacy, and biomarker response evaluations of three oral PD-L1 inhibitors: INCB086550, INCB099280, and INCB099318. J Immunother Cancer. 2026 Aug 11;14(8):e015334. doi: 10.1136/jitc-2026-015334.
PubMed 42580817
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Select Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04242199
- Acronym / sponsor ID
- INCB 99280-112
- Conditions
- Advanced Solid Tumor, MSI-H/dMMR Tumors, Cutaneous Squamous Cell Carcinoma, Urothelial Carcinoma, Cervical Cancer, HepatoCellular Carcinoma
- Keywords
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 21 Nov 2024 (actual)
- First posted
- 27 Jan 2020 (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.
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study consists of 2 parts. Part 1 is a dose-escalation design to identify the maximum tolerant dose and/or pharmacologically active dose for INCB099280. Part 2 is an expansion at 1 or more dose levels to further explore safety, preliminary efficacy, pharmacokinetic, and pharmacodynamic effects.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: INCB099280Participants with select solid tumors who are immunotherapy treatment-naive |
| Cohort 2 | Experimental | Drug: INCB099280Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve. |
| Cohort 3 | Experimental | Drug: INCB099280Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment.
- Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered nonamenable to surgery or other curative treatments or procedures.
- Eastern Cooperative Oncology Group performance status score of 0 or 1.
- Life expectancy > 12 weeks.
- Willingness to avoid pregnancy or fathering children.
Key exclusion criteria (13 listed)
- Laboratory values outside the Protocol-defined ranges.
- Clinically significant cardiac disease.
- History or presence of an electrocardiogram that, in the investigator's opinion, is clinically meaningful.
- Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
- Known additional malignancy that is progressing or requires active 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 |
|---|---|---|
| INCB099280INCB099280 administered orally in 25 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Number of treatment-emergent adverse events
Time frame: Up to approximately 25 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 30 days after last dose of study drug.
8 secondary outcomes
Cmax of INCB099280
Time frame: Up to approximately 3 months
tmax of INCB099280
Time frame: Up to approximately 3 months
Cmin of INCB099280
Time frame: Up to approximately 3 months
AUC0-t of INCB099280
Time frame: Up to approximately 3 months
t½ of INCB099280
Time frame: Up to approximately 3 months
λz of INCB099280
Time frame: Up to approximately 3 months
CL/F of INCB099280
Time frame: Up to approximately 3 months
Vz/F of INCB099280
Time frame: Up to approximately 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Derived from this study: PubMed 42580817Prenen H, Rottey S, Pinato DJ, Lesimple T, Van Cutsem E, Robert M, Galot R, Piha-Paul SA, Tomasini P, Kotecki N, Kristeleit R, Le Tourneau C, Plummer R, Banerji U, Meniawy T, Howe J, Daniel J, Pulini J, Spitz S, Gong X, Halloran M, Italiano A. Phase I safety, efficacy, and biomarker response evaluations of three oral PD-L1 inhibitors: INCB086550, INCB099280, and INCB099318. J Immunother Cancer. 2026 Aug 11;14(8):e015334. doi: 10.1136/jitc-2026-015334.
- Individual participant dataSharing planned: No. There is no plan to share data
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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
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCB099280 in people with Advanced Solid Tumor and MSI-H/dMMR Tumors, run by Incyte Corporation at 21 sites in 5 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Belgium, France, Australia, Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of treatment-emergent adverse events (time frame: Up to approximately 25 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04242199, which also lists 1 linked publication.
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 14 Jul 2025.