A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive

Advanced Solid Tumor Clinical Trial

Official title:

A Phase 2 Study Evaluating INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05879822
• Other study ID #: INCB 99280-211
• Secondary ID: 2022-502716-37-0
• Status: Recruiting
• Phase: Phase 2
• Start date: October 30, 2023
• Est. completion date: January 30, 2027

Study information

• Verified date: June 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced solid tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 314
• Est. completion date: January 30, 2027
• Est. primary completion date: January 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Immunotherapy naive and without access to approved and/or available immune checkpoint inhibitor (ICI) therapy.

• Measurable disease per RECIST v1.1.

• One of the following disease settings:

• Unresectable or metastatic Child-Pugh Class A hepatocellular carcinoma (HCC) not eligible for surgical and/or locoregional therapy and have not received prior systemic therapy or had disease progression following primary therapy.

• Unresectable or metastatic cutaneous melanoma and have not received more than 1 previous systemic therapy for advanced disease.

• Unresectable Stage III PD-L1-positive (TPS = 50% using the Dako PD-L1 IHC 22C3 assay) non-small cell lung cancer (NSCLC) without actionable molecular biomarkers and have not received prior systemic therapy and where chemoradiation is contraindicated; in addition, able to provide fresh or archival tumor tissue for central confirmation of PD-L1 expression.

• Stage IV PD-L1-positive (TPS = 50% using the Dako PD-L1 IHC 22C3 assay) NSCLC without actionable molecular biomarkers and have not received prior systemic therapy; in addition, able to provide fresh or archival tumor tissue for central confirmation of PD-L1 expression.

• Relapsed or Stage IV clear cell renal cell carcinoma (RCC) after having received 1 prior systemic therapy for relapsed or Stage IV disease.

• Cisplatin-ineligible, locally advanced or Stage IV urothelial cancer (UC) and have not received prior systemic therapy for locally advanced or Stage IV UC and able to provide fresh or archival tumor tissue for central confirmation of PD-L1 expression using the Dako PD-L1 IHC 22C3 assay.

• Advanced or metastatic microsatellite instability high (MSI-H) or deficient mismatch repair (dMMR) (as determined by an approved assay) solid tumors and able to provide fresh or archival tumor tissue for central confirmation of MSI-H or dMMR.

• 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 PD-1, anti-PD-L1, or anti-PD-L2 agent or 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 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.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• INCB099280
Administered as specified in the treatment arm description

Locations

Country	Name	City	State
Brazil	Fundacao Pio Xii Hospital de Cancer de Barretos	Barretos
Brazil	Cionc-Centro Integrado de Oncologia de Curitiba	Curitiba
Brazil	Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Câncer	Curitiba
Brazil	Oncosite - Centro de Pesquisa Clinica E Oncologia	Ijui
Brazil	Clinica de Neoplasias Litoral Ltda	Itajaí
Brazil	Fundacao Doutor Amaral Carvalho	JAÚ
Brazil	Hospital Bruno Born	Lajeado
Brazil	Hospital de Cancer de Londrina	Londrina
Brazil	Hospital Sao Vicente de Paulo	Passo Fundo
Brazil	Hgb - Hospital Giovanni Battista - Mae de Deus Center	Porto Alegre
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre
Brazil	Hospital Ernesto Dornelles	Porto Alegre
Brazil	Hospital Nossa Senhora Da Conceicao	Porto Alegre
Brazil	Irmandade Da Santa Casa de Misericordia de Porto Alegre	Porto Alegre
Brazil	Grupo Oncoclínicas	Rio de Janeiro
Brazil	Nob - Nucleo de Oncologia Da Bahia	Salvador
Brazil	Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia	Santo Andre
Brazil	Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto	Sao Jose Do Rio Preto
Brazil	A. C. Camargo Cancer Center	São Paulo
Brazil	Hospital Santa Marcelina	São Paulo
Brazil	Instituto Do Cancer de Sao Paulo - Icesp	São Paulo
China	Sun Yat-Sen University Cancer Center	Guangzhou
China	The First Affiliated Hospital of Zhejiang University	Hangzhou
China	The People'S Hospital of Guangxi Zhuang Autonomous Region	Nanning
Georgia	High Technology Hospital Medcenter	Batumi
Georgia	Jsc Evex Hospitals	Kutaisi
Georgia	Archangel St. Michael Multi Profile Clinical Hospital	Tbilisi
Georgia	Cancer Research Center Ltd	Tbilisi
Georgia	Caucasus Medical Centre Llc	Tbilisi
Georgia	Institute of Clinical Oncology Ltd	Tbilisi
Georgia	Israel-Georgian Medical Research Clinic Helsicore	Tbilisi
Georgia	Medulla Chemotherapy and Immunotherapy Clinic	Tbilisi
Georgia	New Hospitals	Tbilisi
Georgia	Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Llc	Tbilisi
Georgia	Tim-Tbilisi Institute of Medicine Ltd	Tbilisi
Georgia	Todua Clinic, Llc	Tbilisi
Greece	251 Air Force General Hospital	Athens
Greece	University Hospital of West Attica - Attikon	Athens
Greece	Euromedica General Clinic of Thessaloniki	Thessaloniki
Hungary	Semmelweis Egyetem	Budapest
Mexico	Health Pharma Professional Research S.A. de C.V.	Ciudad de México
Mexico	Hospital Civil de Guadalajara Fray Antonio Alcalde	Guadalajara
Mexico	Centro de Atención E Investigación Clínica En Oncología	Merida
Mexico	Oncare Viaducto Napoles	Mexico
Mexico	Joaquin Gabriel Reinoso Toledo	Monterrey
Mexico	Oaxaca Site Management Organization	Oaxaca
Mexico	Centro Potosino de Investigación Medica S.C.	San Luis Potosi
Mexico	Oncologico Potosino	San Luis Potosí
New Zealand	Dunedin Hospital	Dunedin
New Zealand	Rotorua Hospital	Rotorua
Romania	Centrul Medical Medicover Victoria	Bucuresti
Romania	Institutul Clinic Fundeni Clinica	Bucuresti
Romania	S.C. Focus Lab Plus Srl	Bucuresti
Romania	Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca
Romania	Medisprof	Cluj-napoca
Romania	Spitalul Clinic Militar de Urgenta Dr. Constantin Papilian Cluj-Napoca	Cluj-napoca
Romania	Centrul de Oncologie Sf. Nectarie Craiova	Craiova
Romania	Sc Radiotherapy Center Cluj Srl	Floresti
Romania	Institutul Regional de Oncologie Iasi	Iasi
Romania	S.C. Medical Center Gral Srl	Ploiesti
Romania	Oncomed Srl	Timisoara
Romania	S C Oncocenter Oncologie Medicala S R L	Timisoara
South Africa	Cape Town Oncology Trials (Pty) Ltd	Cape Town
South Africa	Johese Clinical Research: Midstream	Centurion
South Africa	The Medical Oncology Centre of Rosebank	Johannesburg
South Africa	Wits Clinical Research	Johannesburg
South Africa	Phoenix Pharma (Pty) Ltd	Port Elizabeth
South Africa	University of Pretoria Oncology Department	Pretoria
Turkey	Medical Park Seyhan Hospital	Adana
Turkey	Hacettepe University Medical Faculty	Ankara
Turkey	Trakya University Medical Faculty	Edirne
Turkey	Goztepe Prof. Dr. Suleyman Yalcin City Hospital	Istanbul
Turkey	Kocaeli Universitesi Tip Fakultesi	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

Brazil,  China,  Georgia,  Greece,  Hungary,  Mexico,  New Zealand,  Romania,  South Africa,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	Defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as determined by investigator radiographic disease assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.	Up to 2 years
Primary	Number of participants with Treatment-emergent Adverse Events (TEAEs)	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.	Up to 2 years 3 months
Primary	Number of participants with TEAEs leading to dose modification or discontinuation	Number of participants with TEAEs leading to dose modification or discontinuation.	Up to 2 years
Secondary	Disease Control Rate (DCR)	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 by investigator assessment per RECIST v1.1.	Up to 2 years
Secondary	Duration Of Response (DOR)	Defined as the time from the earliest date of CR or PR until the earliest date of disease progression, as determined by investigator radiographic disease assessment according to RECIST v1.1, or death due to any cause if occurring sooner than progression.	Up to 2 years
Secondary	INCB099280 pharmacokinetic (PK) in Plasma	INCB099280 concentration 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)