Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Jun 6, 2023
  • participants needed
    140
  • sponsor
    Incyte Corporation
Updated on 23 July 2022

Summary

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.

Details
Condition Advanced Solid Tumors, MSI-H/dMMR Tumors, Cutaneous Squamous Cell Carcinoma, Urothelial Carcinoma, HCC, Cervical Cancer, Esophageal Squamous Cell Carcinoma, Merkel Cell Carcinoma, Small-cell Lung Cancer, Mesothelioma, PD-L1 Amplified Tumor (9p24.1), Nasopharyngeal Carcinoma, Cyclin-dependent Kinase 12 Mutated Tumors, Basal Cell Carcinoma (Unresectable or Metastatic), Sarcomatoid Renal Cell Carcinoma, Clear Cell Ovarian or Endometrial Carcinoma, Anal Carcinoma, Squamous Cell Penile Carcinoma, DNA Polymerase Epsilon Mutated Tumors (P286R and V411L)
Treatment INCB099318
Clinical Study IdentifierNCT04272034
SponsorIncyte Corporation
Last Modified on23 July 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
ECOG performance status score of 0 or 1
Life expectancy > 12 weeks
Willingness to avoid pregnancy or fathering children

Exclusion Criteria

Exclusion Criteria
Laboratory values outside the Protocol-defined ranges
Clinically significant cardiac disease
History or presence of an ECG 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 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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