This is a first in-human, Open-label Phase 1/2 study to assess the safety and activity of ACR-2316 for the treatment of subjects with specific, histologically confirmed, locally advanced, recurrent or metastatic solid tumors.
The Phase 1/2 monotherapy clinical trial for ACR-2316 is designed to assess the safety, tolerability and preliminary evaluation of anti-tumor activity of ACR-2316. Additional objectives include the determination of the maximal tolerated dose and recommended Phase 2 monotherapy dose, characterization of the pharmacokinetic profile and pharmacogenomics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
ACR-2316 is an experimental drug
HonorHealth Research Institute
Phoenix, Arizona, United States
RECRUITINGPrecision NextGen Oncology & Research Center
Beverly Hills, California, United States
Dose Escalation
To determine the MTD of ACR-2316.
Time frame: Number of DLT events during the DLT observation period (up to 28 days)
Dose Expansion
To determine the RP2D of ACR-2316, safety and preliminary evaluation of anti-tumor activity
Time frame: RP2D supported by safety, PK and PD data through study completion
Dose Expansion
To assess the safety and tolerability of ACR-2316
Time frame: Incidence and grades of TEAEs and TRAEs per NCI CTCAE v.5.0 and number of dose decreases, number of dose delays, and SAEs through study completion, an average of 1 year.
Dose Expansion
To determine preliminary anti-tumor activity of ACR-2316.
Time frame: Confirmed ORR per Recist v1.1 and DOR, CBR, assessed every 6 weeks from baseline thorough study completion, an average 1 year or until death.
Dose Escalation
To assess the safety and tolerability of ACR-2316. Safety will be assessed by the incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment.
Time frame: This will be evaluated through study completion
Dose Escalation
To assess Pharmacokinetics: maximum plasma drug concentration (Cmax).
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
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Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
RECRUITINGDenver Health One
Denver, Colorado, United States
RECRUITINGFlorida Cancer Specialist
Sarasota, Florida, United States
RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
RECRUITINGRoswell Park Comprehensive Cancer Center
Buffalo, New York, United States
RECRUITINGMontefiore Medical Centre
The Bronx, New York, United States
RECRUITINGCarolina BioOncology Institute
Huntersville, North Carolina, United States
RECRUITING...and 5 more locations
To assess Pharmacokinetics: minimum plasma drug concentration (Cmin).
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
To assess Pharmacokinetics: time to maximum plasma drug concentration (tmax).
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
To assess Pharmacokinetics: time of last quantifiable plasma drug concentration (tlast).
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
To assess Pharmacokinetics: area under the plasma concentration versus time curve (AUC).
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
To assess Pharmacokinetics: plasma drug concentration at 24 hours post-dose (C24).
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
To assess Pharmacokinetics: apparent volume of distribution (Vz/F).
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
To assess Pharmacokinetics: terminal elimination half-life (t½).
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
To assess Pharmacokinetics: apparent oral clearance (CL/F).
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
To assess Pharmacokinetics: maximum plasma drug concentration (Cmax).
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
To assess Pharmacokinetics: minimum plasma drug concentration (Cmin).
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
To assess Pharmacokinetics: time to maximum plasma drug concentration (tmax).
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
To assess Pharmacokinetics: time of last quantifiable plasma drug concentration (tlast).
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
To assess Pharmacokinetics: area under the plasma concentration versus time curve (AUC).
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
To assess Pharmacokinetics: plasma drug concentration at 24 hours post-dose (C24).
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
To assess Pharmacokinetics: apparent volume of distribution (Vz/F).
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
To assess Pharmacokinetics: terminal elimination half-life (t½).
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
To assess Pharmacokinetics: apparent oral clearance (CL/F).
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.