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-etrumadenant

Phase 1

Healthy Participants | Small molecule | Other |Arcus Biosciences, Inc.|Last Updated: May 24, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials3
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05411146A Study Investigating the Safety, Absorption, and Elimination of Radioactively Labeled Etrumadenant, a New Compound in the Treatment of CancerPHASE1 COMPLETED 8 — — May 25, 2022Jul 7, 2022May 24, 20241 Netherlands
NCT05277012A Study to Evaluate Pharmacokinetics (PK) of Etrumadenant Tablet and Capsule Formulations in Healthy Adult ParticipantsPHASE1 COMPLETED 24 — — Feb 10, 2022Mar 31, 2022May 24, 20241 United States
NCT05154136A Drug-Drug Interaction Study to Evaluate the Effect of Itraconazole on the Pharmacokinetic Profile of Etrumadenant in Healthy Adult ParticipantsPHASE1 COMPLETED 20 — — Oct 20, 2021Dec 10, 2021May 24, 20241 United States
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Study Endpoints
Primary Endpoints
Excretion of total radioactivity in urine
Up to 25 days
Excretion of total radioactivity in feces
Up to 25 days
Percentage of total radioactivity in urine at selected time points
Up to 25 days
Percentage of total radioactivity in feces at selected time points
Up to 25 days
Mass balance recovery of total radioactivity in urine
Up to 25 days
Mass balance recovery of total radioactivy in feces
Up to 25 days
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Up to 38 days
Number of participants with abnormal electrocardiogram (ECG) readings, abnormal vital signs, abnormal physical examinations and abnormal clinical laboratory tests results
Up to 38 days
Maximum Observed Plasma Concentration (Cmax) of Etrumadenant
Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Area Under the Plasma Concentration-time Curve From 0 to Last Observed Non-zero Concentration [AUC(0-t)] of Etrumadenant
Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Area Under the Plasma Concentration Time Curve From Time '0' Extrapolated to Infinity [AUC(0-inf)] of Etrumadenant
Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Time to Cmax (Tmax) of Etrumadenant
Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Apparent First-order Terminal Elimination Rate Constant (Kel) of Etrumadenant
Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Percentage of AUC(0-inf) Extrapolation (AUC%extrap) of Etrumadenant
Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Apparent First Order Terminal Elimination Half-life (t1/2) of Etrumadenant
Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Apparent Total Plasma Clearance (CL/F) of Etrumadenant
Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Etrumadenant
Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Ratio of Etrumadenant metabolites to Etrumadenant
Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Ratio of Etrumadenant metabolites to Total Metabolite Concentration
Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Maximum Observed Plasma Concentration (Cmax) of Etrumadenant Administered With or Without Itraconazole
Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2
Area Under the Plasma Concentration-time Curve From 0 to Last Observed Non-zero Concentration [AUC(0-t)] of Etrumadenant Administered With or Without Itraconazole
Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2
Area Under the Plasma Concentration Time Curve From Time '0' Extrapolated to Infinity [AUC(0-inf)] of Etrumadenant Administered With or Without Itraconazole
Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Period 1; and Days 5, 6, 7, 9, and 11 during Period 2
Secondary Endpoints
Percentage of total radioactivity in blood
Up to 24 days
Percentage of total radioactivity in plasma
Up to 24 days
Maximum Observed Plasma Concentration (Cmax)
Up to 25 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
[14C]-etrumadenantEXPERIMENTALParticipants will receive a single dose of \[14C\]-etrumadenant.
Treatment sequence ABCEXPERIMENTALParticipants will be sequentially administered with Treatment A, B then C (Treatment A: etrumadenant capsule in fasted state; Treatment B: etrumadenant tablet in fasted state; Treatment C: etrumadenant tablet in fed state). Each treatment will be separated by a washout period of 7 days.
Treatment sequence BCAEXPERIMENTALParticipants will be sequentially administered with Treatment B, C then A. Each treatment will be separated by a washout period of 7 days.
Treatment sequence CABEXPERIMENTALParticipants will be sequentially administered with Treatment C, A then B. Each treatment will be separated by a washout period of 7 days.
Etrumadenant then Etrumadenant + ItraconazoleEXPERIMENTALParticipants will receive the Treatment A (etrumadenant) followed by Treatment B (etrumadenant + itraconazole). A washout period of 5 days will be maintained between the two treatments.
Interventions
NameTypeDescription
[14C]-etrumadenantDRUGAdministered as specified in the treatment arm.
EtrumadenantDRUGEtrumadenant capsule and tablet formulations
ItraconazoleDRUGCapsule
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * BMI between 18.0 to 32.0 kg/m2 * Body weight ≥50 kg * Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator. * All clinical laboratory test results within the normal range...

Countries:NetherlandsUnited States
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