For Healthcare Professionals

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

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About the study

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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. 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.
  2. 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.
  3. Eastern Cooperative Oncology Group performance status score of 0 or 1.
  4. Life expectancy > 12 weeks.
  5. Willingness to avoid pregnancy or fathering children.

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Laboratory values outside the Protocol-defined ranges.
  2. Clinically significant cardiac disease.
  3. History or presence of an electrocardiogram that, in the investigator's opinion, is clinically meaningful.
  4. 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).
  5. Known additional malignancy that is progressing or requires active treatment.
  6. 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.
  7. Prior receipt of an anti-PD-L1 therapy.
  8. Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
  9. A 28-day washout for systemic antibiotics is required.
  10. Probiotic usage while on study and during screening is prohibited.
  11. Active infection requiring systemic therapy.
  12. Known history of Human Immunodeficiency Virus (HIV)
  13. Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

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

Age (in years)

18+

Phase

Phase 1

Participants needed

203

Est. Completion Date

Oct 31, 2025

Treatment type

Interventional


Sponsor

Incyte Corporation

ClinicalTrials.gov identifier

NCT04242199

Study number

INCB 99280-112

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