A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Select Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Jun 28, 2024
  • participants needed
    372
  • sponsor
    Incyte Corporation
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Updated on 28 October 2022
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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 Advanced Solid Tumor, MSI-H/dMMR Tumors, Cutaneous Squamous Cell Carcinoma, Urothelial Carcinoma, Cervical Cancer, HepatoCellular Carcinoma, Esophageal Squamous Cell Carcinoma, Merkel Cell Carcinoma, Small-cell Lung Cancer, Mesothelioma, PD-L1 Amplified Tumor (9p24.1), Nasopharyngeal Carcinoma
Treatment INCB099280
Clinical Study IdentifierNCT04242199
SponsorIncyte Corporation
Last Modified on28 October 2022

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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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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