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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04272034
Other study ID # INCB 99318-122
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date March 26, 2021
Est. completion date June 20, 2026

Study information

Verified date February 2024
Source Incyte Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 105
Est. completion date June 20, 2026
Est. primary completion date January 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Advanced Solid Tumors
  • Anal Carcinoma
  • Basal Cell Carcinoma (Unresectable or Metastatic)
  • Carcinoma
  • Carcinoma, Basal Cell
  • Carcinoma, Merkel Cell
  • Carcinoma, Renal Cell
  • Carcinoma, Squamous Cell
  • Cervical Cancer
  • Clear Cell Ovarian or Endometrial Carcinoma
  • Cutaneous Squamous Cell Carcinoma
  • Cyclin-dependent Kinase 12 Mutated Tumors
  • DNA Polymerase Epsilon Mutated Tumors (P286R and V411L)
  • Endometrial Neoplasms
  • Esophageal Squamous Cell Carcinoma
  • Merkel Cell Carcinoma
  • Mesothelioma
  • MSI-H/dMMR Tumors
  • Nasopharyngeal Carcinoma
  • Neoplasms
  • PD-L1 Amplified Tumor (9p24.1)
  • Sarcomatoid Renal Cell Carcinoma
  • Small Cell Lung Carcinoma
  • Small-cell Lung Cancer
  • Squamous Cell Penile Carcinoma
  • Urothelial Carcinoma, HCC

Intervention

Drug:
INCB099318
INCB099318 administered orally in 20 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle.

Locations

Country Name City State
Belgium Institut Jules Bordet Brussels
Belgium Universitair Ziekenhuis Brussel Brussels
Belgium Universitair Ziekenhuis Antwerpen (Uza) Edegem
Belgium Ghent University Hospital Ghent
Belgium Universitaire Ziekenhuis Leuven - Gasthuisberg Leuven
Denmark Rigshospitalet Uni of Hospital of Copenhagen Copenhagen
Finland Docrates Cancer Center Helsinki
Finland Helsinki University Central Hospital Helsinki
Finland Tampere University Hospital Tampere
Finland Turku University Hospital Turku
Norway Haukeland University Hospital Bergen
Norway Oslo University Hospital Oslo
Sweden Sahlgrenska University Hospital Goteborg
Sweden Karolinska University Hospital Solna Solna
Sweden Uppsala Universitet - Akademiska Sjukhuset Uppsala
United Kingdom Western General Hospital Edinburgh
United Kingdom St James University Hospital Leeds
United Kingdom Guys and St Thomas Nhs Foundation Trust London
United Kingdom Imperial College Healthcare Nhs Trust - Hammersmith Hospital London
United Kingdom The Royal Marsden Hospital Nhs Trust London London
United Kingdom Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust Newcastle Upon Tyne
United States Prisma Health Cancer Institute Faris Greenville South Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  Finland,  Norway,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of treatment-emergent adverse events Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 30 days after last dose of study drug. Up to approximately 25 months
Secondary Cmax of INCB099318 Maximum observed plasma concentration Up to approximately 3 months
Secondary tmax of INCB099318 Time to maximum plasma concentration Up to approximately 3 months
Secondary Cmin of INCB099318 Minimum observed plasma concentration over the dose interval Up to approximately 3 months
Secondary AUC0-t of INCB099318 Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t Up to approximately 3 months
Secondary t½ of INCB099318 Apparent terminal-phase disposition half-life Up to approximately 3 months
Secondary ?z of INCB099318 Terminal elimination rate constant Up to approximately 3 months
Secondary CL/F of INCB099318 Oral dose clearance Up to approximately 3 months
Secondary Vz/F of INCB099318 Apparent oral dose volume of distribution Up to approximately 3 months
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