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

Sponsor

Incyte Corporation (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05888844

Collaborator

(none)

240

Enrollment

Arms

42.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cutaneous Squamous Cell Carcinoma	Drug: INCB099280	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study consists of 2 parts. In Part 1, participants with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC will be randomized 1:1:1 to INCB099280 Dose 1, Dose 2, or Dose 3. In Part 2, one dose level identified from Part 1 will be expanded to enroll additional participants with metastatic cSCC and locally advanced cSCC.The study consists of 2 parts. In Part 1, participants with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC will be randomized 1:1:1 to INCB099280 Dose 1, Dose 2, or Dose 3. In Part 2, one dose level identified from Part 1 will be expanded to enroll additional participants with metastatic cSCC and locally advanced cSCC.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 2 Study Evaluating INCB099280 in Participants With Advanced Squamous Cell Carcinoma

Anticipated Study Start Date :

Jun 16, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: INCB099280 Dose 1 Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years.	Drug: INCB099280 Administered as specified in the treatment arm description.
Experimental: Part 1: INCB099280 Dose 2 Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years.	Drug: INCB099280 Administered as specified in the treatment arm description.
Experimental: Part 1: INCB099280 Dose 3 Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years.	Drug: INCB099280 Administered as specified in the treatment arm description.
Experimental: Part 2: INCB099280 Dose selected from Part 1 Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years.	Drug: INCB099280 Administered as specified in the treatment arm description.

Outcome Measures

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Overall Survival (OS) [Up to 2 years]
Defined as the time from the date of first dose to death due to any cause.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Incyte Corporation

Investigators

Study Director: Incyte Medical Monitor, Incyte Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Incyte Corporation

ClinicalTrials.gov Identifier:

NCT05888844

Other Study ID Numbers:

INCB 99280-212
2022-502476-23-00

First Posted:

Jun 5, 2023

Last Update Posted:

Jun 5, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Incyte Corporation

Cutaneous Squamous Cell Carcinoma

Anti-PD-L1 antibody

Metastatic cutaneous squamous cell carcinoma

Locally advanced cutaneous squamous cell carcinoma

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Squamous Cell

Study Results

No Results Posted as of Jun 5, 2023