Advanced Solid TumorsPhase 1NCT04272034
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors
A Phase 1 study testing INCB099318 in people with Advanced Solid Tumors and MSI-H/dMMR Tumors, run by Incyte Corporation at 24 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, MSI-H/dMMR Tumors, Cutaneous Squamous Cell Carcinoma
- What is being tested?
- INCB099318
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 24 sitesin 7 countries
- Study dates
- 26 Mar 2021to 16 Aug 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.
- ECOG 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 ECG 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 HIV
- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
Trial locations and contacts
24 sites in 7 countries.
24 sites in 7 countries
United Kingdom6 sites
Western General Hospital
Edinburgh, EH4 2XU
St James University Hospital
Leeds, LS9 7TF
Guys and St Thomas Nhs Foundation Trust
London, SE1 9RT
The Royal Marsden Hospital Nhs Trust London
London, SM2 5PT
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London, W12 0HS
Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust
Newcastle upon Tyne, NE7 7DN
Belgium5 sites
Universitair Ziekenhuis Brussel
Brussels, 01090
Institut Jules Bordet
Brussels, B-1070
Universitair Ziekenhuis Antwerpen (Uza)
Edegem, 02650
Ghent University Hospital
Ghent, 09000
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven, 03000
Finland4 sites
Helsinki University Central Hospital
Helsinki, 00029
Docrates Cancer Center
Helsinki, 00180
Tampere University Hospital
Tampere, 33520
Turku University Hospital
Turku, 20520
United States3 sites
Prisma Health Cancer Institute Faris
Greenville, South Carolina, 29605
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Sweden3 sites
Sahlgrenska University Hospital
Gothenburg, 41345
Karolinska University Hospital Solna
Solna, 17164
Uppsala Universitet - Akademiska Sjukhuset
Uppsala, 75185
Norway2 sites
Haukeland University Hospital
Bergen, 05051
Oslo University Hospital
Oslo, 00450
About this study
Official title: A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Select Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.
- Conditions
- Advanced Solid Tumors, MSI-H/dMMR Tumors, Cutaneous Squamous Cell Carcinoma, Urothelial Carcinoma, HCC, Cervical Cancer, Esophageal Squamous Cell Carcinoma
- Being tested
- INCB099318
- Keywords
- Advanced solid tumors
- Medical subject headings
- Carcinoma, Transitional Cell, Uterine Cervical Neoplasms, Esophageal Squamous Cell Carcinoma, Carcinoma, Merkel Cell, Small Cell Lung Carcinoma, Mesothelioma, Nasopharyngeal Carcinoma, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB099318Drug
INCB099318 administered orally in 20 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: INCB099318 |
| Cohort 2 | Experimental | Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve. Receives: Drug: INCB099318 |
| Cohort 3 | Experimental | Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy Receives: Drug: INCB099318 |
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 INCB099318
Maximum observed plasma concentration
Measured: Up to approximately 3 months
tmax of INCB099318
Time to maximum plasma concentration
Measured: Up to approximately 3 months
Cmin of INCB099318
Minimum observed plasma concentration over the dose interval
Measured: Up to approximately 3 months
AUC0-t of INCB099318
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 INCB099318
Apparent terminal-phase disposition half-life
Measured: Up to approximately 3 months
λz of INCB099318
Terminal elimination rate constant
Measured: Up to approximately 3 months
CL/F of INCB099318
Oral dose clearance
Measured: Up to approximately 3 months
Vz/F of INCB099318
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 posted17 Feb 2020
- Study start26 Mar 2021
- Primary completion16 Aug 2024
- Study completion16 Aug 2024
Why it stopped: A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.
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 TumorsStudies 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 tolerated dose and/or pharmacologically active dose for INCB099318. Part 2 is an expansion at 1 or more dose levels to further explore safety, preliminary efficacy, pharmacoketics, and pharmacodynamic effects.
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Louis Viviers, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272034
- Sponsor's protocol ID
- INCB 99318-122
- Other IDs
- 2019-004990-21, 2019
- Status last verified
- Oct 2025
- First submitted
- 13 Feb 2020
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Access to patient level data is not available for this study
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 16 Oct 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 INCB099318 in Participants With Select Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04272034
- Acronym / sponsor ID
- INCB 99318-122
- Conditions
- Advanced Solid Tumors, MSI-H/dMMR Tumors, Cutaneous Squamous Cell Carcinoma, Urothelial Carcinoma, HCC, Cervical Cancer, Esophageal Squamous Cell Carcinoma
- Keywords
- Advanced solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 17 Feb 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, and pharmacodynamics of INCB099318 in 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 tolerated dose and/or pharmacologically active dose for INCB099318. Part 2 is an expansion at 1 or more dose levels to further explore safety, preliminary efficacy, pharmacoketics, and pharmacodynamic effects.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: INCB099318Participants with select solid tumors who are immunotherapy treatment-naive |
| Cohort 2 | Experimental | Drug: INCB099318Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve. |
| Cohort 3 | Experimental | Drug: INCB099318Participants 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.
- ECOG 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 ECG 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 |
|---|---|---|
| INCB099318INCB099318 administered orally in 20 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 INCB099318
Time frame: Up to approximately 3 months
tmax of INCB099318
Time frame: Up to approximately 3 months
Cmin of INCB099318
Time frame: Up to approximately 3 months
AUC0-t of INCB099318
Time frame: Up to approximately 3 months
t½ of INCB099318
Time frame: Up to approximately 3 months
λz of INCB099318
Time frame: Up to approximately 3 months
CL/F of INCB099318
Time frame: Up to approximately 3 months
Vz/F of INCB099318
Time frame: Up to approximately 3 months
Results and safety
The study was stopped early (reason given: A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 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. Access to patient level data is not available for this study
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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.
Louis Viviers, MD study director
Incyte Corporation
24 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCB099318 in people with Advanced Solid Tumors and MSI-H/dMMR Tumors, run by Incyte Corporation at 24 sites in 7 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: stopped early, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United Kingdom, Belgium, Finland, United States, Sweden and 2 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 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 was stopped early (reason given: A business decision was made to discontinue further enrollment. There were no safety concerns that contributed 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?
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 NCT04272034, 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 16 Oct 2025.