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

PHASE1TerminatedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

March 26, 2021

Primary Completion Date

August 16, 2024

Study Completion Date

August 16, 2024

Conditions
Advanced Solid TumorsMSI-H/dMMR TumorsCutaneous Squamous Cell CarcinomaUrothelial Carcinoma, HCCCervical CancerEsophageal Squamous Cell CarcinomaMerkel Cell CarcinomaSmall-cell Lung CancerMesotheliomaPD-L1 Amplified Tumor (9p24.1)Nasopharyngeal CarcinomaCyclin-dependent Kinase 12 Mutated TumorsBasal Cell Carcinoma (Unresectable or Metastatic)Sarcomatoid Renal Cell CarcinomaClear Cell Ovarian or Endometrial CarcinomaAnal CarcinomaSquamous Cell Penile CarcinomaDNA Polymerase Epsilon Mutated Tumors (P286R and V411L)
Interventions
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.

Trial Locations (24)

17164

Karolinska University Hospital Solna, Solna

20520

Turku University Hospital, Turku

29605

Prisma Health Cancer Institute Faris, Greenville

33520

Tampere University Hospital, Tampere

37232

Vanderbilt-Ingram Cancer Center, Nashville

41345

Sahlgrenska University Hospital, Gothenburg

75185

Uppsala Universitet - Akademiska Sjukhuset, Uppsala

07601

Hackensack University Medical Center, Hackensack

01090

Universitair Ziekenhuis Brussel, Brussels

B-1070

Institut Jules Bordet, Brussels

02650

Universitair Ziekenhuis Antwerpen (Uza), Edegem

09000

Ghent University Hospital, Ghent

03000

Universitaire Ziekenhuis Leuven - Gasthuisberg, Leuven

02100

Rigshospitalet Uni of Hospital of Copenhagen, Copenhagen

00029

Helsinki University Central Hospital, Helsinki

00180

Docrates Cancer Center, Helsinki

05051

Haukeland University Hospital, Bergen

00450

Oslo University Hospital, Oslo

EH4 2XU

Western General Hospital, Edinburgh

LS9 7TF

St James University Hospital, Leeds

SE1 9RT

Guys and St Thomas Nhs Foundation Trust, London

SM2 5PT

The Royal Marsden Hospital Nhs Trust London, London

W12 0HS

Imperial College Healthcare Nhs Trust - Hammersmith Hospital, London

NE7 7DN

Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust, Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyte Corporation

INDUSTRY