NCT04272034TerminatedPhase 1
A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Select Advanced Solid Tumors
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Incyte Corporation
- Enrollment
- 105
- Locations
- 24
- Primary Endpoint
- Number of treatment-emergent adverse events
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Cohort 1
Experimental
Participants with select solid tumors who are immunotherapy treatment-naive
Intervention: INCB099318 (Drug)
Cohort 2
Experimental
Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve.
Intervention: INCB099318 (Drug)
Cohort 3
Experimental
Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy
Intervention: INCB099318 (Drug)
Outcomes
Primary Outcomes
Number of treatment-emergent adverse events
Time Frame: Up to approximately 25 months
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.
Secondary Outcomes
- Cmin of INCB099318(Up to approximately 3 months)
- AUC0-t of INCB099318(Up to approximately 3 months)
- t½ of INCB099318(Up to approximately 3 months)
- λz of INCB099318(Up to approximately 3 months)
- Cmax of INCB099318(Up to approximately 3 months)
- tmax of INCB099318(Up to approximately 3 months)
- CL/F of INCB099318(Up to approximately 3 months)
- Vz/F of INCB099318(Up to approximately 3 months)
Investigators
Study Sites (24)
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