Last updated 7 months ago
Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors
100 patients around the world
Available in United States, Mexico, Brazil
Incyte Corporation
9Research sites
100Patients around the world
This study is for people with
Solid tumors
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Prior systemic therapy, diagnoses and disease setting as follows: For Part 1 (dose escalation), and no history of treatment with anti-CTLA-4 or anti-PD-(L)1 therapy and one of the following, Unresectable or metastatic cutaneous melanoma, or Unresectable of metastatic Child-Pugh Class A NDD not eligible for surgical and/or locoregional therapy, or Intermediate or poor-risk advanced clear cell RCC, or MSI-H or dMMR metastatic CRC and able to provide fresh or archival tumor tissue for central confirmation of MSI-H or dMMR. For Part 2 (dose expansion), IO treatment -naïve, e.g., no prior receipt of an anti PD-1, anti-PD-L1 or PD-L1, anti-CTLA-4, GITR, LAG3, TIM3, OX-40, IL-2, 4-1BB or other immune modulator, and have not received prior systemic therapy and one of the following, Unresectable or metastatic Child-Pugh Class A HCC not eligible for surgical and/or locoregional therapy, or Intermediate - or poor-risk advanced clear cell RCC. ECOG performance score of 0 or 1. Life expectancy > 3 months, in the opinion of the investigator. Histologically confirmed solid tumors with measurable disease per RECIST v1.1. Exception: HCC may be diagnoses based on cross-sectional multiphasic imagining using the AASLD criteria. 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.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 of clinically significant cardiac disease.History of evidence of interstitial lung disease including non-infections pneumonitis.Presence of gastrointestinal condition that may affect drug absorptionAny 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 equivalentActive infection requiring systemic therapy.History of organ transplantation, including allogeneic stem cell transplantation.Receipt of system antibiotics within 28 days of first dose of study treatment.Probiotic usage is prohibited during the screening and throughout the study treatment periodReceived a live vaccine within 28 days of planned start of study drug.Laboratory values outside the Protocol-defined ranges.
Sites
Oncocentro - Belo Horizonte
UPCO Unidade de Pesquisa Clinica em Oncologia
Hospital Nossa Senhora da Conceição
Instituto de Oncologia Saint Gallen
Preparaciones Oncológicas S.C. - Mexico
Cryptex Investigación Clínica
Clinical Medical Research S.C.
Centro Potosino de Investigación Médica
Centro Médico Zambrano Hellion
SponsorIncyte Corporation
Conditions
Solid tumors
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05909995
