A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive
- Registration Number
- NCT05879822
- 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 solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 73
-
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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: INCB099280 Dose 1 INCB099280 Participants will receive INCB099280 dose 1 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 Part 1: INCB099280 Dose 2 INCB099280 Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years. 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.
- Primary Outcome Measures
Name Time Method 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.
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 investigator radiographic disease assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Secondary Outcome Measures
Name Time Method 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 by investigator assessment per RECIST v1.1.
Duration Of Response (DOR) Up to 2 years 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.
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
Trial Locations
- Locations (54)
Fundacao Pio Xii Hospital de Cancer de Barretos
🇧🇷Barretos, Brazil
Cionc-Centro Integrado de Oncologia de Curitiba
🇧🇷Curitiba, Brazil
Oncosite - Centro de Pesquisa Clinica E Oncologia
🇧🇷Ijui, Brazil
Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Câncer
🇧🇷Curitiba, Brazil
Clinica de Neoplasias Litoral Ltda
🇧🇷Itajaí, Brazil
Fundacao Doutor Amaral Carvalho
🇧🇷JAÚ, Brazil
Hospital de Cancer de Londrina
🇧🇷Londrina, Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, Brazil
Hgb - Hospital Giovanni Battista - Mae de Deus Center
🇧🇷Porto Alegre, Brazil
Hospital Ernesto Dornelles
🇧🇷Porto Alegre, Brazil
Hospital Nossa Senhora Da Conceicao
🇧🇷Porto Alegre, Brazil
Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
🇧🇷Santo Andre, Brazil
A. C. Camargo Cancer Center
🇧🇷São Paulo, Brazil
Caucasus Medical Centre Llc
🇬🇪Tbilisi, Georgia
Todua Clinic, Llc
🇬🇪Tbilisi, Georgia
New Hospitals
🇬🇪Tbilisi, Georgia
Tim-Tbilisi Institute of Medicine Ltd
🇬🇪Tbilisi, Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Llc
🇬🇪Tbilisi, Georgia
Institute of Clinical Oncology Ltd
🇬🇪Tbilisi, Georgia
Cancer Research Center Ltd
🇬🇪Tbilisi, Georgia
251 Air Force General Hospital
🇬🇷Athens, Greece
Medulla Chemotherapy and Immunotherapy Clinic
🇬🇪Tbilisi, Georgia
University Hospital of West Attica - Attikon
🇬🇷Athens, Greece
Euromedica General Clinic of Thessaloniki
🇬🇷Thessaloniki, Greece
Dunedin Hospital
🇳🇿Dunedin, New Zealand
Rotorua Hospital
🇳🇿Rotorua, New Zealand
Centrul Medical Medicover Victoria
🇷🇴Bucuresti, Romania
Spitalul Clinic Militar de Urgenta Dr. Constantin Papilian Cluj-Napoca
🇷🇴Cluj-napoca, Romania
Medisprof
🇷🇴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
Cape Town Oncology Trials (Pty) Ltd
🇿🇦Cape Town, South Africa
S C Oncocenter Oncologie Medicala S R L
🇷🇴Timisoara, Romania
Oncomed Srl
🇷🇴Timisoara, Romania
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
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, Turkey
The People'S Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, China
High Technology Hospital Medcenter
🇬🇪Batumi, Georgia
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Orszagos Onkologiai Intezet
🇭🇺Budapest, Hungary
Jsc Evex Hospitals
🇬🇪Kutaisi, Georgia
Israel-Georgian Medical Research Clinic Helsicore
🇬🇪Tbilisi, Georgia
Archangel St. Michael Multi Profile Clinical Hospital
🇬🇪Tbilisi, Georgia
Institutul Clinic Fundeni Clinica
🇷🇴Bucuresti, Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
🇷🇴Cluj Napoca, Romania