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

Cervical Cancer Clinical Trial

Official title:

A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Select Advanced Solid Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04272034
• Other study ID #: INCB 99318-122
• Status: Active, not recruiting
• Phase: Phase 1
• 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
• 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.

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