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

Phase 2

Active, not recruiting

• Conditions: Cutaneous Squamous Cell Carcinoma
• Interventions: Drug: INCB099280

• Registration Number: NCT05888844
• Lead Sponsor: Incyte Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-06-05
• Study Start: 2023-10-09
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-03
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 TEAEs leading to dose modification or discontinuation	Up to 2 years	Number of participants with TEAEs leading to dose modification or discontinuation.
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.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Up to 2 years	Defined as the time from the date of first dose to the earliest date of disease progression as determined by the BICR according to RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC or death due to any cause if occurring sooner than progression.
INCB099280 pharmacokinetic (PK) in Plasma	Pre dose and 1, 2 and 6 hours post dose on Cycle 1 Day 1 and Cycle 2 Day 1. Pre dose every other cycle until Cycle 11 Day 1 (Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1 and Cycle 11 Day 1) (each cycle is 28 days)	INCB099280 concentration in plasma
Disease Control Rate (DCR)	Up to 2 years	Defined as the percentage of participants with the best overall response of CR or PR, or stable disease (SD), after a minimum of 15 weeks following the initiation of study treatment as determined by the BICR per RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC.
Duration Of Response (DOR)	Up to 2 years	Defined as the time from the earliest date of confirmed CR or PR to the earliest date of disease progression, as determined by the BICR according to RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC or death due to any cause if occurring sooner than progression.
Time to Response (TTR)	Up to 2 years	Defined as the time from the date of first dose to the earliest date of confirmed CR or PR as determined by the BICR according to RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC.
Overall Survival (OS)	Up to 2 years	Defined as the time from the date of first dose to death due to any cause.

Trial Locations

Locations (77)

Border Medical Oncology Research Unit; 🇦🇺 Albury, New South Wales, Australia

Townsville Cancer Centre; 🇦🇺 Townsville, Queensland, Australia

Princess Alexandra Hospital Australia; 🇦🇺 Woolloongabba, Queensland, Australia

Box Hill Hospital; 🇦🇺 Box Hill, Victoria, Australia

Monash Medical Centre Clayton; 🇦🇺 Clayton, Victoria, Australia

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; 🇧🇷 Ijui, Brazil

Fundacao Doutor Amaral Carvalho; 🇧🇷 JAÚ, Brazil

Hospital Sao Vicente de Paulo; 🇧🇷 Passo Fundo, Brazil

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