Safety Tolerability Pharmacokinetics and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Jun 28, 2024
  • participants needed
    140
  • sponsor
    Incyte Corporation
Updated on 11 September 2021
solid tumors
solid tumour

Summary

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid tumors

Details
Condition Cervical Cancer, Adenocarcinoma, Disorders of cervix NOS, Neuroendocrine carcinoma, Uterine Cancer, Carcinoma, Esophageal Cancer, Squamous cell carcinoma, Transitional cell carcinoma, HEPATIC NEOPLASM, Nasopharyngeal Cancer, Small Cell Lung Cancer, Mesothelioma, HEPATOCELLULAR CARCINOMA, Mesothelioma, Merkel cell carcinoma, Vulvar Dysplasia and Carcinoma, Advanced Solid Tumor, Malignant Mesothelioma, Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Esophagus, Advanced Malignancies, Cutaneous Squamous Cell Carcinoma, Skin Squamous Cell Carcinoma, Advanced Malignant Solid Tumor, Liver Cancer, Malignant Adenoma, Urothelial Carcinoma, MSI-H/dMMR Tumors, PD-L1 Amplified Tumor (9p24.1), MSI-H/dMMR Tumors, PD-L1 Amplified Tumor (9p24.1), cervical carcinoma, nasopharyngeal carcinoma, cervical cancer, uterine, carcinoma of the cervix uteri, carcinoma of the cervix, cervix cancer, cancer of the cervix, carcinoma of cervix, liver cell carcinoma, sclc, small cell carcinoma, small cell carcinoma of the lung, squamous cell skin cancer, MSI-H/dMMR Tumors, PD-L1 Amplified Tumor (9p24.1), MSI-H/dMMR Tumors, PD-L1 Amplified Tumor (9p24.1), MSI-H/dMMR Tumors, PD-L1 Amplified Tumor (9p24.1), MSI-H/dMMR Tumors, PD-L1 Amplified Tumor (9p24.1), MSI-H/dMMR Tumors, PD-L1 Amplified Tumor (9p24.1), MSI-H/dMMR Tumors, PD-L1 Amplified Tumor (9p24.1), MSI-H/dMMR Tumors, PD-L1 Amplified Tumor (9p24.1)
Treatment INCB099280
Clinical Study IdentifierNCT04242199
SponsorIncyte Corporation
Last Modified on11 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment
Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered nonamenable to surgery or other curative treatments or procedures
Eastern Cooperative Oncology Group performance status score of 0 or 1
Life expectancy > 12 weeks
Willingness to avoid pregnancy or fathering children

Exclusion Criteria

Laboratory values outside the Protocol-defined ranges
Clinically significant cardiac disease
History or presence of an electrocardiogram that, in the investigator's opinion, is clinically meaningful
Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases)
Known additional malignancy that is progressing or requires active treatment
Has not recovered to Grade 1 or baseline from toxic effects of prior therapy (including prior IO) and/or complications from prior surgical intervention before starting study treatment
Prior receipt of an anti-PD-L1 therapy
Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug
A 28-day washout for systemic antibiotics is required
Probiotic usage while on study and during screening is prohibited
Active infection requiring systemic therapy
Known history of Human Immunodeficiency Virus (HIV)
Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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