A PHASE 2 STUDY EVALUATING INCB099280 IN PARTICIPANTS WITH SELECT SOLID TUMORS WHO ARE IMMUNE CHECKPOINT INHIBITOR–NAÏVE - INCB 99280-211

Incyte Corp.0 个研究点目标入组 328 人开始时间: 2023年5月17日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: Incyte Corp.
入组人数: 328

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•Ability to comprehend and willingness to sign a written ICF for the study., Age 18 years or older inclusive at the time of signing the ICF., Prior systemic therapy, diagnoses, and disease settings as follows: a. Immunotherapy naive b. Measurable disease per RECIST v1.1 c. One of the following disease settings: see protocol, ECOG performance score of 0 or 1 (except for UC, where a score of up to 2 is permitted)., Life expectancy > 3 months, Willingness to avoid pregnancy or fathering children

排除标准

•Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of disease recurrence for 3 years since initiation of that therapy., Presence of gastrointestinal conditions that may affect drug absorption, as well as those that interfere with gastrointestinal transit, Any autoimmune disease requiring systemic treatment in the past 5 years, including corticosteroids of a daily dose exceeding 10 mg of prednisone or equivalent, Diagnosis of primary immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent, HIV infection and any one or more of the following: CD4+ T-cell count < 200 cells/µL, detectable viral load per parameters of assay, or antiretroviral therapy regimen containing moderate or potent CYP3A4/CYP3A5 inhibitors or inducers, Active infection requiring systemic therapy, with the exception of HIV and hepatitis, History of organ transplantation, including allogeneic stem cell transplantation., Known hypersensitivity or severe reaction to any component of study drug or formulation components., Postoperative complications preventing the participant from adhering protocol assessments and procedures., 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., CNS metastases requiring treatment and/or leptomeningeal disease., Received a live vaccine within 28 days of the planned start of study drug. Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, some shingles, yellow fever, rabies, BCG, and typhoid vaccines. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live-attenuated vaccines and are not allowed. Note: If enrolled, participants should not receive live vaccine during the study and up to 28 days after the last dose of study drug., Treatment with moderate and potent CYP3A4/CYP3A5 inhibitors or inducers, Unable to be weaned off of a prohibited medication before the initiation of study treatment., Participants with laboratory values at screening as defined in the protocol, Clinically significant ECG abnormality, including average QTcF interval > 480 milliseconds, Active HBV or HCV as follows (testing must be performed): a.Detectable HBV DNA (viral load) and HBsAg. b. Participants with chronic HBV infection with active disease who meet the criteria for anti-HBV therapy are required to be on a suppressive antiviral therapy prior to initiation of study treatment. c. Active HCV is defined as a positive HCV antibody result and quantitative HCV RNA (viral load) result greater than the lower limit of detection, Pregnant, expecting to conceive, or breastfeeding or expecting to father children, Any condition that would, in the investigator's judgment, interfere with full participation in the study, The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code., Toxicity from prior therapy that has not recovered to = Grade 1 or baseline, Prior receipt

研究者

发起方

Incyte Corp.

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