This study is testing a new medicine, SNV4818, for people with advanced cancers. The researchers want to find out if SNV4818 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the safest and most effective one.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
Fulvestrant is administered via an intramuscular injection. It will be given at a dose of 500 mg (2-250 mg/5 mL injections)
Palbociclib tablets will be administered by mouth on days 1-21 of a 28 day cycle. The Palbociclib starting dose will be 125 mg once-daily
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
Los Angeles, California, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
Incidence of dose limiting toxicities (DLTs)
-Number of participants experiencing protocol-defined DLTs (Part 1A and 2A only)
Time frame: First 28 days of study treatment
Treatment Emergent Adverse Events (TEAEs)
Incidence and frequency of TEAEs
Time frame: From first SNV4818 dose through approximately 30 days following the last SNV4818 dose
Maximum observed plasma concentration of SNV4818
Cmax
Time frame: After 4 weeks (1 cycle) of study treatment
Time to reach the maximum observed plasma concentration of SNV4818
Tmax
Time frame: After 4 weeks (1 cycle) of study treatment
Area Under Plasma Concentration (AUC) Time Curve of SNV4818
AUC0-t
Time frame: After 4 weeks (1 cycle) of study treatment
Half-life of SNV4818
t1/2
Time frame: After 4 weeks (1 cycle) of study treatment
Area Under Plasma Concentration (AUC) Time Curve of SNV4818 extrapolated to infinity
AUC0-infinity
Time frame: After 1 day of study treatment
Apparent oral clearance of SNV4818
CL/F
Time frame: After 4 weeks (1 cycle) of study treatment
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Thomas Jefferson University-Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
RECRUITINGSarah Cannon Research Institute
Nashville, Tennessee, United States
RECRUITINGThe University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
RECRUITINGChris O'Brien Lifehouse
Camperdown, New South Wales, Australia
RECRUITINGScientia Clinical Research
Randwick, New South Wales, Australia
RECRUITINGMonash Health
Clayton, Victoria, Australia
RECRUITINGPeter MacCallum Cancer Centre
Melbourne, Victoria, Australia
RECRUITINGLinear Clinical Research
Nedlands, Western Australia, Australia
RECRUITING...and 2 more locations
Apparent volume of distribution of SNV4818
Vz/F
Time frame: After 4 weeks (1 cycle) of study treatment
Overall response rate (ORR)
The proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR), based on RECIST 1.1 criteria
Time frame: After 8 weeks on study treatment
Disease control rate (DCR)
The proportion of participants who have a best overall response (BOR) of stable disease (SD) or better
Time frame: After 8 weeks on study treatment
Duration of response (DOR)
The time interval between an assessment of partial response (PR) or better and disease progression or death due to any cause.
Time frame: Up to approximately 2 years