A FIH study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VVD-130850, as single agent and in combination with checkpoint inhibition, in participants with advanced solid and hematologic tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Oral tablets
IV infusion
California Research Institute
Los Angeles, California, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Dose Escalation: Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period
Incidence and severity of DLTs will be assessed per DLT criteria set forth in the protocol based on adverse events (AEs) evaluated per National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: From Day 1 to Day 21 of Cycle 1 [cycle length=21 days]
Dose Expansion: Number of Participants with AEs and Serious Adverse Events (SAEs)
Time frame: Up to approximately 4 years
Dose Expansion: Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to approximately 4 years
Dose Expansion: Number of Participants with Clinically Significant Changes in Laboratory Evaluations
Time frame: Up to approximately 4 years
Dose Escalation: QT/Corrected QT (QTc) Interval and Other Electrocardiogram (ECG) Parameters
Number of participants with changes in QT/QTc interval and other ECG parameters will be assessed.
Time frame: Up to approximately 4 years
Dose Escalation: Recommended Dose for Expansion (RDE) of VVD-130850 as a Single Agent and in Combination with Pembrolizumab
The RDE will be based on safety, pharmacokinetics, pharmacodynamic biomarker data, and preliminary anti-tumor activity collected during the study as defined by the safety review committee.
Time frame: Up to approximately 4 years
Dose Expansion: Overall Response Rate (ORR)
ORR is defined as the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sarah Cannon Research Institute
Nashville, Tennessee, United States
NEXT Austin
Austin, Texas, United States
MDACC
Houston, Texas, United States
NEXT Dallas
Irving, Texas, United States
NEXT San Antonio
San Antonio, Texas, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
NEXT Virginia
Fairfax, Virginia, United States
Blacktown Hospital
Blacktown, New South Wales, Australia
...and 10 more locations
Time frame: Up to approximately 4 years
Dose Expansion: Duration of Response (DoR)
DOR is defined as the time from initial response of CR or PR to progressive disease or death, whichever comes first per RECIST version 1.1 by investigator assessment.
Time frame: Up to approximately 4 years
Dose Expansion: Progression-free Survival (PFS)
PFS is defined as the time from the date of randomization to the time of confirmed disease progression or death, whichever occurs first per RECIST version 1.1 by investigator assessment.
Time frame: Up to approximately 4 years
Dose Expansion: Disease Control Rate (DCR)
DCR is defined as the percentage of participants achieving CR or PR, or stable disease (SD) per RECIST version 1.1 by investigator assessment.
Time frame: Up to approximately 4 years
Dose Escalation and Expansion: Area Under the Plasma Concentration-time Curve (AUC) of VVD-130850
Time frame: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days)
Dose Escalation and Expansion: Maximum Plasma Concentration (Cmax) of VVD-130850
Time frame: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days)
Dose Escalation and Expansion: Apparent Terminal Half-life (t1/2) of VVD-130850
Time frame: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days)