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

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

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: INCB099280

• Study Type: Interventional
• Enrollment (Estimated): 314
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Incyte Corporation Call Center (US); Phone Number: 1.855.463.3463; Email: medinfo@incyte.com
• Study Contact Backup: Name: Incyte Corporation Call Center (ex-US); Phone Number: +800 00027423; Email: eumedinfo@incyte.com

Study Locations

• Brazil
  • Barretos, Brazil, 14784-400
    • Not yet recruiting
    • Fundacao Pio XII Hospital de Cancer de Barretos
  • Curitiba, Brazil, 80810-050
    • Recruiting
    • CIONC-Centro Integrado de Oncologia de Curitiba
  • Curitiba, Brazil, 81520-060
    • Recruiting
    • Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Câncer
  • Ijui, Brazil, 98700-000
    • Not yet recruiting
    • Oncosite - Centro de Pesquisa Clinica E Oncologia
  • Itajaí, Brazil, 88301-220
    • Recruiting
    • Clínica de Neoplasias Litoral Ltda
  • JAÚ, Brazil, 17210-120
    • Recruiting
    • Fundacao Doutor Amaral Carvalho
  • Lajeado, Brazil, 95900-000
    • Not yet recruiting
    • Hospital Bruno Born
  • Londrina, Brazil, 86015-520
    • Recruiting
    • Hospital de Cancer de Londrina
  • Passo Fundo, Brazil, 99010-080
    • Not yet recruiting
    • Hospital Sao Vicente de Paulo
  • Pelotas, Brazil, 96020-080
    • Not yet recruiting
    • Clinica Lacks - Unidade de Pesquisas Clinicas Em Oncologia (Upco)
  • Porto Alegre, Brazil, 90035-903
    • Not yet recruiting
    • Hospital de Clinicas de Porto Alegre
  • Porto Alegre, Brazil, 90160-093
    • Recruiting
    • Hospital Ernesto Dornelles
  • Porto Alegre, Brazil, 90020-090
    • Recruiting
    • Irmandade da Santa Casa de Misericordia de Porto Alegre
  • Porto Alegre, Brazil, 91350-200
    • Recruiting
    • Hospital Nossa Senhora da Conceicao
  • Porto Alegre, Brazil, 90110-270
    • Recruiting
    • Hgb - Hospital Giovanni Battista - Mae de Deus Center
  • Rio de Janeiro, Brazil, 22250-905
    • Not yet recruiting
    • Grupo Oncoclínicas
  • Salvador, Brazil, 40170110
    • Not yet recruiting
    • Nob - Nucleo de Oncologia Da Bahia
  • Santo Andre, Brazil, 09060-870
    • Not yet recruiting
    • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
  • Sao Jose Do Rio Preto, Brazil, 15090-000
    • Not yet recruiting
    • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
  • São Paulo, Brazil, 08270-070
    • Not yet recruiting
    • Hospital Santa Marcelina
  • São Paulo, Brazil, 01246-000
    • Not yet recruiting
    • Instituto Do Cancer de Sao Paulo - Icesp
  • São Paulo, Brazil, 01509-900
    • Recruiting
    • A. C. Camargo Cancer Center
• China
  • Hangzhou, China, 310003
    • Withdrawn
    • The First Affiliated Hospital of Zhejiang University
  • Nanning, China, 530021
    • Not yet recruiting
    • The People's Hospital of Guangxi Zhuang Autonomous Region
• Georgia
  • Batumi, Georgia, 06004
    • Recruiting
    • High Technology Hospital Medcenter
  • Kutaisi, Georgia, 04600
    • Recruiting
    • JSC Evex Hospitals
  • Tbilisi, Georgia, 00112
    • Recruiting
    • Todua Clinic, Llc
  • Tbilisi, Georgia, 00114
    • Recruiting
    • New Hospitals
  • Tbilisi, Georgia, 00102
    • Recruiting
    • Archangel St. Michael Multi Profile Clinical Hospital
  • Tbilisi, Georgia, 00112
    • Recruiting
    • Israel-Georgian Medical Research Clinic Helsicore
  • Tbilisi, Georgia, 00159
    • Recruiting
    • Institute of Clinical Oncology LTD
  • Tbilisi, Georgia, 00177
    • Recruiting
    • Cancer Research Center Ltd
  • Tbilisi, Georgia, 00000
    • Recruiting
    • Caucasus Medical Centre Llc
  • Tbilisi, Georgia, 00141
    • Recruiting
    • Tim-Tbilisi Institute of Medicine Ltd
  • Tbilisi, Georgia, 00144
    • Recruiting
    • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Llc
  • Tbilisi, Georgia, 00186
    • Recruiting
    • Medulla Chemotherapy and Immunotherapy Clinic
• Greece
  • Athens, Greece, 12462
    • Recruiting
    • University Hospital of West Attica - Attikon
  • Athens, Greece, 115 25
    • Recruiting
    • 251 Air Force General Hospital
  • Thessaloniki, Greece, 54645
    • Recruiting
    • EUROMEDICA General Clinic of Thessaloniki
• Hungary
  • Budapest, Hungary, 01083
    • Not yet recruiting
    • Semmelweis Egyetem
  • Budapest, Hungary, 01122
    • Not yet recruiting
    • Orszagos Onkologiai Intezet
  • Kecskemet, Hungary, 06000
    • Not yet recruiting
    • Bacs Kiskun Megyei Oktatokorhaz
• Mexico
  • Ciudad de México, Mexico, 03100
    • Not yet recruiting
    • Health Pharma Professional Research S.A. de C.V.
  • Guadalajara, Mexico, 44280
    • Not yet recruiting
    • Hospital Civil de Guadalajara Fray Antonio Alcalde
  • Merida, Mexico, 97134
    • Not yet recruiting
    • Centro de Atencion e Investigacion Clinica en Oncologia
  • Mexico, Mexico, 14300
    • Not yet recruiting
    • ONCARE Viaducto Napoles
  • Monterrey, Mexico, 64320
    • Not yet recruiting
    • Joaquin Gabriel Reinoso Toledo
  • Oaxaca, Mexico, 68000
    • Not yet recruiting
    • Oaxaca Site Management Organization
  • San Luis Potosi, Mexico, 78250
    • Not yet recruiting
    • Centro Potosino de Investigación Medica S.C.
  • San Luis Potosí, Mexico, 78250
    • Not yet recruiting
    • Oncologico Potosino
• New Zealand
  • Dunedin, New Zealand, 09016
    • Recruiting
    • Dunedin Hospital
  • Rotorua, New Zealand, 03010
    • Recruiting
    • Rotorua Hospital
• Romania
  • Bucuresti, Romania, 22548
    • Not yet recruiting
    • S.C. Focus Lab Plus Srl
  • Bucuresti, Romania, 10626
    • Recruiting
    • Centrul Medical Medicover Victoria
  • Bucuresti, Romania, 22328
    • Recruiting
    • Institutul Clinic Fundeni Clinica
  • Cluj Napoca, Romania, 400015
    • Recruiting
    • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
  • Cluj-napoca, Romania, 400132
    • Recruiting
    • Spitalul Clinic Militar de Urgenta Dr. Constantin Papilian Cluj-Napoca
  • Cluj-napoca, Romania, 400641
    • Recruiting
    • Medisprof
  • Craiova, Romania, 200347
    • Recruiting
    • Centrul de Oncologie Sf. Nectarie Craiova
  • Floresti, Romania, 407280
    • Recruiting
    • Sc Radiotherapy Center Cluj Srl
  • Iasi, Romania, 700483
    • Recruiting
    • Institutul Regional de Oncologie Iasi
  • Ploiesti, Romania, 100337
    • Recruiting
    • S.C. Medical Center Gral Srl
  • Timisoara, Romania, 300239
    • Recruiting
    • Oncomed Srl
  • Timisoara, Romania, 300166
    • Recruiting
    • S C Oncocenter Oncologie Medicala S R L
• South Africa
  • Cape Town, South Africa, 07570
    • Not yet recruiting
    • Cape Town Oncology Trials (Pty) Ltd
  • Centurion, South Africa, 01692
    • Recruiting
    • Johese Clinical Research: Midstream
  • Johannesburg, South Africa, 02193
    • Not yet recruiting
    • Wits Clinical Research
  • Johannesburg, South Africa, 02196
    • Recruiting
    • The Medical Oncology Centre of Rosebank
  • Port Elizabeth, South Africa, 06001
    • Recruiting
    • Phoenix Pharma (Pty) Ltd
  • Pretoria, South Africa, 00084
    • Not yet recruiting
    • University of Pretoria Oncology Department
• Turkey
  • Adana, Turkey, 01230
    • Not yet recruiting
    • Adana Sehir Hastanesi
  • Adana, Turkey, 01140
    • Not yet recruiting
    • Medical Park Seyhan Hospital
  • Ankara, Turkey, 06100
    • Recruiting
    • Hacettepe University Medical Faculty
  • Ankara, Turkey, 06800
    • Not yet recruiting
    • Ankara City Hospital
  • Edirne, Turkey, 22030
    • Not yet recruiting
    • Trakya University Medical Faculty
  • Istanbul, Turkey, 34093
    • Not yet recruiting
    • Goztepe Prof. Dr. Suleyman Yalcin City Hospital
  • Istanbul, Turkey, 34098
    • Not yet recruiting
    • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
  • Kocaeli, Turkey, 41380
    • Not yet recruiting
    • Kocaeli Universitesi Tip Fakultesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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)

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Incyte Medical Monitor, Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; Non-small Cell Lung Cancer; Advanced Solid Tumor; Urothelial Cancer; Cutaneous Melanoma; Renal Cell Carcinoma; PD-L1-positive NSCLC; MSI-H/dMMR Tumors
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: INCB 99280-211; 2022-502716-37-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No