UP-NEXT is a double-blind, randomized, placebo-controlled study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion once every four weeks in patients with recurrent, platinum-sensitive high-grade serous ovarian cancer (HGSOC), including fallopian tube and primary peritoneal cancer, expressing high levels of NaPi2b.
This is a multi-center randomized study of XMT-1536 (upifitamab rilsodotin) in patients with tumors expressing high levels of NaPi2b, focusing on patients with recurrent, platinum-sensitive high-grade serous ovarian cancer (HGSOC) including fallopian tube and primary peritoneal cancer. The randomized study design is a double-blind, placebo-controlled study, with a randomization ratio of 2:1. All adverse events will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria version (CTCAE v5.0). Participants must have had 4 to 8 cycles of platinum-based chemotherapy in their most recent treatment regimen, including carboplatin or cisplatin ± paclitaxel, docetaxel, pegylated liposomal doxorubicin or gemcitabine in the 2nd-4th line setting for the treatment of platinum-sensitive recurrent disease, with no evidence of disease (NED)/complete response (CR)/partial response (PR)/ or stable disease (SD) as best response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Upifitimab rilsodotin will be administered once every four weeks until completion, disease progression, unacceptable toxicity, voluntary discontinuation, or death (approximately up to 18 months).
Placebo controlled arm.
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
PFS is defined as the time from randomization to the earliest date of progressive disease as assessed by BICR per RECIST Version 1.1 or death due to any cause.
Time frame: Up to 12 months after the last dose for the last participant.
Overall Survival (OS)
OS is defined as the time from randomization to the date of death due to any cause.
Time frame: Up to an average of 4 years. Follow up assessments for survival data will continue every 90 days following completion of treatment.
Progression-free Survival (PFS) as assessed by Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
PFS is defined as the time from randomization to the earliest date of progressive disease as assessed by Investigator per RECIST Version 1.1 or death due to any cause.
Time frame: Up to 12 months after the last dose for the last participant.
Adverse events (AEs) based on NCI CTCAE Version 5.0
Incidence and toxicity grade of AEs.
Time frame: Up to 60 days past last dose
Changes in Eastern Cooperative Oncology Group (ECOG) performance status
Assessment of ECOG performance status using ECOG performance scale.
Time frame: Up to 60 days past last dose.
Objective Response Rate (ORR) as assessed by Investigator using RECIST Version 1.1
ORR is the percentage of patients achieving a confirmed complete response (CR) or partial response (PR) as assessed by Investigator per RECIST Version 1.1.
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HonorHealth Research Institute - HonorHealth VGPCC Biltmore
Phoenix, Arizona, United States
The University of Arizona Cancer Center
Tucson, Arizona, United States
University of California Los Angeles, Gynecologic Oncology Clinic
Los Angeles, California, United States
University of California, Irvine Medical Center
Orange, California, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
WK Physicians
Shreveport, Louisiana, United States
Karmanos Cancer Institute - Detroit
Detroit, Michigan, United States
Billings Clinic
Billings, Montana, United States
Methodist Hospital
Omaha, Nebraska, United States
...and 20 more locations
Time frame: Up to 12 months after the last dose for the last participant.
Number of participants using concomitant medications
Assessment of concomitant medication usage.
Time frame: Up to 60 days past last dose.