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

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