The purpose of this study is to determine safety and tolerability of AVB-500 when given in combination with paclitaxel in patients with recurrent high-grade uterine cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
IV over 3 hours
IV over 60 minutes
Frequency and severity of treatment-emergent adverse events
-Graded by CTCAE v.5.
Time frame: From start of treatment though 30 days after the last dose of AVB-500 (estimated to be 31 weeks)
Serum sAXL and GAS6 ratio
Time frame: At baseline
Pharmacokinetic (PK) parameters (including Cmax) as determined from AVB-500 serum levels
Time frame: Cycle 1 Day 1 pre-infusion, Cycle 1 Day 1 post-infusion, Cycle 1 Day 15 pre-infusion, and subsequent cycles day 1 pre-infusions (each cycle is 21 days)
Pharmacokinetic (PK) parameters (including Tmax) as determined from AVB-500 serum levels
Time frame: Cycle 1 Day 1 pre-infusion, Cycle 1 Day 1 post-infusion, Cycle 1 Day 15 pre-infusion, and subsequent cycles day 1 pre-infusions (each cycle is 21 days)
Pharmacodynamic effects as determined by changes from baseline in serum GAS6 levels
Time frame: Cycle 1 Day 1 pre-infusion, Cycle 1 Day 1 post-infusion, Cycle 1 Day 15 pre-infusion, and subsequent cycles day 1 pre-infusions (each cycle is 21 days)
Overall response rate (ORR)
-Defined as the proportion of subjects who have a partial or complete response to therapy
Time frame: Through completion of treatment (estimated to be 27 weeks)
Progression-free survival (PFS)
-Defined as the time from start of treatment to the first radiologically documented disease progression, or death, whichever comes first. The alive patients without radiologically documented disease progression are censored at the last follow-up.
Time frame: Through completion of follow-up (estimated to be 5 years and 27 weeks)
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Recommended Phase 2 dose (RP2D) of AVB-500 in combination with paclitaxel
Time frame: Through completion of cycle 1 (cycle=21 days) for all patients (estimated to be 48 months and 3 weeks)
Incidence of anti-drug antibodies (ADA)
Time frame: Day 1 of each cycle (cycle-21 days) and end of treatment (estimated to be 27 weeks)
Overall survival (OS)
-Defined as the time from start of treatment to death. The alive patients are censored at the last follow-up.
Time frame: Through completion of follow-up (estimated to be 5 years and 27 weeks)