Clinical Trials in South Korea / NCT05888844
Active, not recruiting
Phase 2
A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma
NCT05888844 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Cutaneous Squamous Cell Carcinoma
Investigational drug(s) / intervention(s)
INCB099280: Administered as specified in the treatment arm description.
Study summary
This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced Cutaneous Squamous Cell Carcinoma.
Eligibility
Inclusion Criteria:
* Histopathological diagnosis of cSCC.
* Previously untreated or recurrent locally advanced (without nodal metastases) or metastatic (distant or regional metastasis) cSCC not amenable to curative surgery and/or radiotherapy.
* Measurable disease based on either radiographic imaging per RECIST 1.1 or WHO criteria.
* 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 anti-PD-1, anti-PD-L1, or anti-PD-L2 agent; 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 primary 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.
* Inadequate organ function.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Primary outcome measure(s)
- Objective response rate (ORR) — 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 the blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or composite criteria for metastatic cSCC and per World Health Organization (WHO) criteria for locally advanced cSCC. - Number of participants with Treatment-emergent Adverse Events (TEAEs) — 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 — Up to 2 years
Number of participants with TEAEs leading to dose modification or discontinuation.
Trial sites (77)
| Facility | City | Region | Status |
|---|---|---|---|
| Border Medical Oncology Research Unit | Albury | New South Wales | |
| Townsville Cancer Centre | Townsville | Queensland | |
| Princess Alexandra Hospital Australia | Woolloongabba | Queensland | |
| Box Hill Hospital | Box Hill | Victoria | |
| Monash Medical Centre Clayton | Clayton | Victoria | |
| Fundacao Pio Xii Hospital de Cancer de Barretos | Barretos | Brazil | |
| Cepen - Centro de Pesquisa E Ensino Em Oncologia de Santa Catarina | Florianópolis | Brazil | |
| Oncosite - Centro de Pesquisa Clinica E Oncologia | Ijuí | Brazil | |
| Fundacao Doutor Amaral Carvalho | Jaú | Brazil | |
| Hospital Sao Vicente de Paulo | Passo Fundo | Brazil | |
| Irmandade Da Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Brazil | |
| Hgb - Hospital Giovanni Battista - Mae de Deus Center | Porto Alegre | Brazil | |
| Instituto de Oncologia Saint Gallen | Santa Cruz do Sul | Brazil | |
| Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia | Santo André | Brazil | |
| A. C. Camargo Cancer Center | São Paulo | Brazil | |
| Q.E. Ii Health Sciences Centre | Halifax | Nova Scotia | |
| McGill University Jewish General Hospital | Montreal | Quebec | |
| Cdiem - Centro de Investigacion Y Especialidades Medicas | Santiago | Chile | |
| James Lind Centro de Investigacion Del Cancer | Temuco | Chile | |
| Clinical Research Chile Spa. | Valdivia | Chile | |
| Specialty Hospital Medico | Rijeka | Croatia | |
| University Hospital Centre Sestre Milosrdnice | Zagreb | Croatia | |
| Avicenne Hospital | Bobigny | France | |
| Bordeaux Chu Hopital Saint - Andre | Bordeaux | France | |
| Hospital Ambroise Pare | Boulogne-Billancourt | France | |
| Chu de Clermont - Ferrand- Hospital Estaing | Clermont-Ferrand | France | |
| Centre Georges Francois Leclerc | Dijon | France | |
| Chu Dijon - Hôpital François Mitterrand | Dijon | France | |
| Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon | La Tronche | France | |
| Chru de Lille Hopital Claude Huriez | Lille | France | |
| Chu Hopital de La Timone | Marseille | France | |
| Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu | Nantes | France | |
| Chu de Nice - Hospital L Archet | Nice | France | |
| Hospital Saint Louis | Paris | France | |
| Centre Hospitalier de Pau - Hôpital François Mitterrand | Pau | France | |
| Hospices Civils de Lyon Centre Hospitalier Lyon Sud | Pierre-Bénite | France | |
| Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume | Rouen | France | |
| University Hospital of Saint Etienne | Saint-Etienne | France | |
| Institut Gustave Roussy | Villejuif | France | |
| Semmelweis Egyetem | Budapest | Hungary |
+ 37 more sites — see the full list on the official registry below.
More Incyte Corporation trials in South Korea
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05888844 on ClinicalTrials.gov ↗ ← All trials in South Korea