Description:
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics,
pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid
tumors
Title
- Brief Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
- Official Title: A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Select Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
INCB 99280-112
- NCT ID:
NCT04242199
Conditions
- Advanced Solid Tumor
- MSI-H/dMMR Tumors
- Cutaneous Squamous Cell Carcinoma
- Urothelial Carcinoma
- Cervical Cancer
- HepatoCellular Carcinoma
- Esophageal Squamous Cell Carcinoma
- Merkel Cell Carcinoma
- Small-cell Lung Cancer
- Mesothelioma
- PD-L1 Amplified Tumor (9p24.1)
- Nasopharyngeal Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
INCB099280 | | Cohort 1 |
Purpose
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics,
pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid
tumors
Trial Arms
Name | Type | Description | Interventions |
---|
Cohort 1 | Experimental | Participants with select solid tumors who are immunotherapy treatment-naive | |
Cohort 2 | Experimental | Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve. | |
Cohort 3 | Experimental | Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy | |
Eligibility Criteria
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.
- Eastern Cooperative Oncology Group performance status score of 0 or 1.
- Life expectancy > 12 weeks.
- Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
- Laboratory values outside the Protocol-defined ranges.
- Clinically significant cardiac disease.
- History or presence of an electrocardiogram 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 Human Immunodeficiency Virus (HIV)
- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of treatment-emergent adverse events |
Time Frame: | Up to approximately 25 months |
Safety Issue: | |
Description: | 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 Outcome Measures
Measure: | Cmax of INCB099280 |
Time Frame: | Up to approximately 3 months |
Safety Issue: | |
Description: | Maximum observed plasma concentration |
Measure: | tmax of INCB099280 |
Time Frame: | Up to approximately 3 months |
Safety Issue: | |
Description: | Time to maximum plasma concentration |
Measure: | Cmin of INCB099280 |
Time Frame: | Up to approximately 3 months |
Safety Issue: | |
Description: | Minimum observed plasma concentration over the dose interval |
Measure: | AUC0-t of INCB099280 |
Time Frame: | Up to approximately 3 months |
Safety Issue: | |
Description: | Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t |
Measure: | t½ of INCB099280 |
Time Frame: | Up to approximately 3 months |
Safety Issue: | |
Description: | Apparent terminal-phase disposition half-life |
Measure: | λz of INCB099280 |
Time Frame: | Up to approximately 3 months |
Safety Issue: | |
Description: | Terminal elimination rate constant |
Measure: | CL/F of INCB099280 |
Time Frame: | Up to approximately 3 months |
Safety Issue: | |
Description: | Oral dose clearance |
Measure: | Vz/F of INCB099280 |
Time Frame: | Up to approximately 3 months |
Safety Issue: | |
Description: | Apparent oral dose volume of distribution |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Incyte Corporation |
Trial Keywords
Last Updated
September 1, 2021