Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors
Stopped early · Phase 1
Conditions studied: 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)
In brief
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.
Key facts
- Study ID
- NCT04272034
- Run by
- Incyte Corporation
- People needed
- 105
- Starts
- 2021-03-26
- Expected to finish
- 2024-08-16
- Last updated by the study team
- 2025-10-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- Prisma Health Cancer Institute Faris — Greenville, South Carolina, United States
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
- Universitair Ziekenhuis Brussel — Brussels, Belgium
- Institut Jules Bordet — Brussels, Belgium
- Universitair Ziekenhuis Antwerpen (Uza) — Edegem, Belgium
- Ghent University Hospital — Ghent, Belgium
- Universitaire Ziekenhuis Leuven - Gasthuisberg — Leuven, Belgium
- Rigshospitalet Uni of Hospital of Copenhagen — Copenhagen, Denmark
- Helsinki University Central Hospital — Helsinki, Finland
- Docrates Cancer Center — Helsinki, Finland
- Tampere University Hospital — Tampere, Finland
- Turku University Hospital — Turku, Finland
- Haukeland University Hospital — Bergen, Norway
- Oslo University Hospital — Oslo, Norway
- Sahlgrenska University Hospital — Gothenburg, Sweden
- Karolinska University Hospital Solna — Solna, Sweden
- Uppsala Universitet - Akademiska Sjukhuset — Uppsala, Sweden
- Western General Hospital — Edinburgh, United Kingdom
- St James University Hospital — Leeds, United Kingdom
- Guys and St Thomas Nhs Foundation Trust — London, United Kingdom
- The Royal Marsden Hospital Nhs Trust London — London, United Kingdom
- Imperial College Healthcare Nhs Trust - Hammersmith Hospital — London, United Kingdom
- Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust — Newcastle upon Tyne, United Kingdom
Full record on ClinicalTrials.gov
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