The trial is taking place at:
C

Clinica Universidad de Navarra | Sede Madrid - Hematology Department

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A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma

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Incyte

Status and phase

Enrolling
Phase 2

Conditions

Cutaneous Squamous Cell Carcinoma

Treatments

Drug: INCB099280

Study type

Interventional

Funder types

Industry

Identifiers

NCT05888844
2022-502476-23-00 (Other Identifier)
INCB 99280-212

Details and patient eligibility

About

This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced Cutaneous Squamous Cell Carcinoma.

Enrollment

240 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

240 participants in 4 patient groups

Part 1: INCB099280 Dose 1
Experimental group
Description:
Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years.
Treatment:
Drug: INCB099280
Part 1: INCB099280 Dose 2
Experimental group
Description:
Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years.
Treatment:
Drug: INCB099280
Part 1: INCB099280 Dose 3
Experimental group
Description:
Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years.
Treatment:
Drug: INCB099280
Part 2: INCB099280 Dose selected from Part 1
Experimental group
Description:
Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years.
Treatment:
Drug: INCB099280

Trial contacts and locations

113

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Central trial contact

Incyte Corporation Call Center (US); Incyte Corporation Call Center (ex-US)

Data sourced from clinicaltrials.gov

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