Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors
Reason given: A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.
Key facts
- Where
- Edinburgh, Leeds, London, and Newcastle upon Tyne, United KingdomSee the 6 sites
- Phase
- Phase 1
Where in United Kingdom
- Western General HospitalEdinburgh, United KingdomNo longer taking part
- St James University HospitalLeeds, United KingdomNo longer taking part
- Guys and St Thomas NHS Foundation TrustLondon, United KingdomNo longer taking part
- Imperial College Healthcare Nhs Trust - Hammersmith HospitalLondon, United KingdomNo longer taking part
- The Royal Marsden Hospital Nhs Trust LondonLondon, United KingdomNo longer taking part
- Freeman Hospital Newcastle Upon Tyne Foundation Nhs TrustNewcastle upon Tyne, United KingdomNo longer taking part
Trial details
- Who runs it
- Incyte Corporation
- Trial code
- NCT04272034
- Record updated
- 16 October 2025
- Original description
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.Read full original descriptionShow less
A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Select Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.
Inclusion: 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: 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; Clinically significant cardiac disease; Known additional malignancy that is progressing or requires active treatment; Active infection requiring systemic therapy; Known history of HIV; Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation; Laboratory values outside the Protocol-defined ranges; 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); Probiotic usage while on study and during screening is prohibited.