A FIH dose escalation and dose expansion study to evaluate VVD-130037 in participants with advanced solid tumors as a single agent, and in combination with docetaxel, paclitaxel, or pembrolizumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
290
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Part 1 (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: Part 1: Single Agent and Docetaxel/Pembrolizumab Combination Therapy: From Day 1 to Day 21 of Cycle 1 [cycle length=21 days] and Part 1: Paclitaxel Combination Therapy: From Day 1 to Day 28 of Cycle 1 [cycle length=28 days]
Part 2 (Dose Expansion): Number of Participants With AEs, Serious Adverse Events (SAEs), and Clinical Laboratory Abnormalities
Time frame: Up to approximately 4 years
Part 1 (Dose Escalation): Number of Participants With AEs, SAEs, and Clinical Laboratory Abnormalities
Time frame: Up to approximately 4 years
Part 2 (Dose Expansion): Recommended Phase 2 Dose (RP2D) of VVD-130037 as a Single Agent and in Combination with Docetaxel, Paclitaxel, or Pembrolizumab
The RP2D will be based on safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of VVD-130037 as single agent, and in combination with docetaxel, paclitaxel, or pembrolizumab during Part 2.
Time frame: Up to approximately 4 years
Part 2 (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) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment.
Time frame: Up to approximately 4 years
Part 2 (Dose Expansion): Duration of Response (DOR)
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IV infusion
Florida Cancer Specialists
Sarasota, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGMayo Clinic Rochester
Rochester, Minnesota, United States
RECRUITINGSarah Cannon Research Institute
Nashville, Tennessee, United States
RECRUITINGMDACC
Houston, Texas, United States
RECRUITINGNEXT Dallas
Irving, Texas, United States
RECRUITINGNEXT Virginia
Fairfax, Virginia, United States
RECRUITINGNational Cancer Center
Goyang, South Korea
RECRUITINGGachon University Gil Medical Center
Incheon, South Korea
RECRUITING...and 15 more locations
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
Part 2 (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
Part 2 (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
Parts 1 and 2 (Dose Escalation and Expansion): Area Under the Plasma Concentration-time Curve (AUC) of VVD-130037
Time frame: Parts 1 and 2: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days for Single Agent and Docetaxel/Pembrolizumab Combination Therapy and cycle length=28 days for Paclitaxel Combination Therapy)
Parts 1 and 2 (Dose Escalation and Expansion): Maximum Observed Concentration (Cmax) of VVD-130037
Time frame: Parts 1 and 2: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days for Single Agent and Docetaxel/Pembrolizumab Combination Therapy and cycle length=28 days for Paclitaxel Combination Therapy)
Parts 1 and 2 (Dose Escalation and Expansion): Apparent Terminal Half-life (T1/2) of VVD-130037
Time frame: Parts 1 and 2: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days for Single Agent and Docetaxel/Pembrolizumab Combination Therapy and cycle length=28 days for Paclitaxel Combination Therapy)
Parts 1 and 2 (Dose Escalation and Expansion): 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: Parts 1 and 2: Up to approximately 4 years