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

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

NCT ID: NCT05879822

Condition: Advanced Solid Tumor

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
Advanced Solid Tumor
Hepatocellular Carcinoma
Cutaneous Melanoma
PD-L1-positive NSCLC
Non-small Cell Lung Cancer
Renal Cell Carcinoma
Urothelial Cancer
MSI-H/dMMR Tumors

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: The study consists of 2 parts. In Part 1, participants with 6 different tumor types will be randomized 1:1:1 to INCB099280 Dose 1, INCB099280 Dose 2, or INCB099280 Dose 3 twice daily (BID). At the end of Part 1, an integrated analysis will be performed to select a dose. Once a dose is selected, Part 2 will proceed to complete enrollment for each of the 6 disease-specific cohorts at the selected dose.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: INCB099280
Description: Administered as specified in the treatment arm description
Arm group label: Part 1: INCB099280 Dose 1
Arm group label: Part 1: INCB099280 Dose 2
Arm group label: Part 1: INCB099280 Dose 3
Arm group label: Part 2: INCB099280 Dose selected from Part 1

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

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Fundacao Pio Xii Hospital de Cancer de Barretos

Address:
City: Barretos
Zip: 14784-400
Country: Brazil

Facility:
Name: Cionc-Centro Integrado de Oncologia de Curitiba

Address:
City: Curitiba
Zip: 80810-050
Country: Brazil

Facility:
Name: Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Câncer

Address:
City: Curitiba
Zip: 81520-060
Country: Brazil

Facility:
Name: Oncosite - Centro de Pesquisa Clinica E Oncologia

Address:
City: Ijui
Zip: 98700-000
Country: Brazil

Facility:
Name: Clinica de Neoplasias Litoral Ltda

Address:
City: Itajaí
Zip: 88301-220
Country: Brazil

Facility:
Name: Fundacao Doutor Amaral Carvalho

Address:
City: JAÚ
Zip: 17210-120
Country: Brazil

Facility:
Name: Hospital de Cancer de Londrina

Address:
City: Londrina
Zip: 86015-520
Country: Brazil

Facility:
Name: Irmandade Da Santa Casa de Misericordia de Porto Alegre

Address:
City: Porto Alegre
Zip: 90020-090
Country: Brazil

Facility:
Name: Hgb - Hospital Giovanni Battista - Mae de Deus Center

Address:
City: Porto Alegre
Zip: 90110-270
Country: Brazil

Facility:
Name: Hospital Ernesto Dornelles

Address:
City: Porto Alegre
Zip: 90160-093
Country: Brazil

Facility:
Name: Hospital Nossa Senhora Da Conceicao

Address:
City: Porto Alegre
Zip: 91350-200
Country: Brazil

Facility:
Name: Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia

Address:
City: Santo Andre
Zip: 09060-870
Country: Brazil

Facility:
Name: A. C. Camargo Cancer Center

Address:
City: São Paulo
Zip: 01509-900
Country: Brazil

Facility:
Name: The People'S Hospital of Guangxi Zhuang Autonomous Region

Address:
City: Nanning
Zip: 530021
Country: China

Facility:
Name: High Technology Hospital Medcenter

Address:
City: Batumi
Zip: 06004
Country: Georgia

Facility:
Name: Jsc Evex Hospitals

Address:
City: Kutaisi
Zip: 04600
Country: Georgia

Facility:
Name: Caucasus Medical Centre Llc

Address:
City: Tbilisi
Zip: 00000
Country: Georgia

Facility:
Name: Archangel St. Michael Multi Profile Clinical Hospital

Address:
City: Tbilisi
Zip: 00102
Country: Georgia

Facility:
Name: Israel-Georgian Medical Research Clinic Helsicore

Address:
City: Tbilisi
Zip: 00112
Country: Georgia

Facility:
Name: Todua Clinic, Llc

Address:
City: Tbilisi
Zip: 00112
Country: Georgia

Facility:
Name: New Hospitals

Address:
City: Tbilisi
Zip: 00114
Country: Georgia

Facility:
Name: Tim-Tbilisi Institute of Medicine Ltd

Address:
City: Tbilisi
Zip: 00141
Country: Georgia

Facility:
Name: Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Llc

Address:
City: Tbilisi
Zip: 00144
Country: Georgia

Facility:
Name: Institute of Clinical Oncology Ltd

Address:
City: Tbilisi
Zip: 00159
Country: Georgia

Facility:
Name: Cancer Research Center Ltd

Address:
City: Tbilisi
Zip: 00177
Country: Georgia

Facility:
Name: Medulla Chemotherapy and Immunotherapy Clinic

Address:
City: Tbilisi
Zip: 00186
Country: Georgia

Facility:
Name: 251 Air Force General Hospital

Address:
City: Athens
Zip: 115 25
Country: Greece

Facility:
Name: University Hospital of West Attica - Attikon

Address:
City: Athens
Zip: 12462
Country: Greece

Facility:
Name: Euromedica General Clinic of Thessaloniki

Address:
City: Thessaloniki
Zip: 54645
Country: Greece

Facility:
Name: Semmelweis Egyetem

Address:
City: Budapest
Zip: 01083
Country: Hungary

Facility:
Name: Orszagos Onkologiai Intezet

Address:
City: Budapest
Zip: 01122
Country: Hungary

Facility:
Name: Dunedin Hospital

Address:
City: Dunedin
Zip: 09016
Country: New Zealand

Facility:
Name: Rotorua Hospital

Address:
City: Rotorua
Zip: 03010
Country: New Zealand

Facility:
Name: Centrul Medical Medicover Victoria

Address:
City: Bucuresti
Zip: 10626
Country: Romania

Facility:
Name: Institutul Clinic Fundeni Clinica

Address:
City: Bucuresti
Zip: 22328
Country: Romania

Facility:
Name: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

Address:
City: Cluj Napoca
Zip: 400015
Country: Romania

Facility:
Name: Spitalul Clinic Militar de Urgenta Dr. Constantin Papilian Cluj-Napoca

Address:
City: Cluj-napoca
Zip: 400132
Country: Romania

Facility:
Name: Medisprof

Address:
City: Cluj-napoca
Zip: 400641
Country: Romania

Facility:
Name: Centrul de Oncologie Sf. Nectarie Craiova

Address:
City: Craiova
Zip: 200347
Country: Romania

Facility:
Name: Sc Radiotherapy Center Cluj Srl

Address:
City: Floresti
Zip: 407280
Country: Romania

Facility:
Name: Institutul Regional de Oncologie Iasi

Address:
City: Iasi
Zip: 700483
Country: Romania

Facility:
Name: S.C. Medical Center Gral Srl

Address:
City: Ploiesti
Zip: 100337
Country: Romania

Facility:
Name: S C Oncocenter Oncologie Medicala S R L

Address:
City: Timisoara
Zip: 300166
Country: Romania

Facility:
Name: Oncomed Srl

Address:
City: Timisoara
Zip: 300239
Country: Romania

Facility:
Name: Cape Town Oncology Trials (Pty) Ltd

Address:
City: Cape Town
Zip: 07570
Country: South Africa

Facility:
Name: Johese Clinical Research: Midstream

Address:
City: Centurion
Zip: 01692
Country: South Africa

Facility:
Name: Wits Clinical Research

Address:
City: Johannesburg
Zip: 02193
Country: South Africa

Facility:
Name: The Medical Oncology Centre of Rosebank

Address:
City: Johannesburg
Zip: 02196
Country: South Africa

Facility:
Name: Phoenix Pharma (Pty) Ltd

Address:
City: Port Elizabeth
Zip: 06001
Country: South Africa

Facility:
Name: Medical Park Seyhan Hospital

Address:
City: Adana
Zip: 01140
Country: Turkey

Facility:
Name: Hacettepe University Medical Faculty

Address:
City: Ankara
Zip: 06100
Country: Turkey

Facility:
Name: Trakya University Medical Faculty

Address:
City: Edirne
Zip: 22030
Country: Turkey

Facility:
Name: Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Address:
City: Istanbul
Zip: 34093
Country: Turkey

Facility:
Name: Kocaeli Universitesi Tip Fakultesi

Address:
City: Kocaeli
Zip: 41380
Country: Turkey

Start date: October 30, 2023

Completion date: January 30, 2027

Lead sponsor:
Agency: Incyte Corporation
Agency class: Industry

Source: Incyte Corporation

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05879822