upifitimab rilsodotin for Carcinoma, Ovarian Epithelial

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Erlanger Womens Oncology, Chattanooga, TN
Carcinoma, Ovarian Epithelial+8 More
upifitimab rilsodotin - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions

  • Carcinoma, Ovarian Epithelial
  • Primary Peritoneal Cancer
  • Malignant neoplasm of ovary
  • Fallopian Tubes Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Carcinoma, Ovarian Epithelial

Study Objectives

2 Primary · 10 Secondary · Reporting Duration: Every 6 weeks and then every 12 weeks until disease progression or start of a new therapy, assessed up to an average of 12 months.

Year 4
Assessment of OS
Month 12
Investigator determined ORR
Investigator determined PFS
PFS assessed by BICR
Month 12
Objective Response Rate (ORR) as assessed by Investigator using RECIST Version 1.1
Progression-free Survival (PFS) as assessed by Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Day 60
Adverse events (AEs) based on NCI CTCAE Version 5.0
Overall Safety
Day 60
Changes in Eastern Cooperative Oncology Group (ECOG) performance status
Number of participants using concomitant medications
Year 4
Overall Survival (OS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Carcinoma, Ovarian Epithelial

Trial Design

2 Treatment Groups

XMT-1536 (upifitamab rilsodotin)
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

350 Total Participants · 2 Treatment Groups

Primary Treatment: upifitimab rilsodotin · Has Placebo Group · Phase 3

XMT-1536 (upifitamab rilsodotin)Experimental Group · 2 Interventions: Upifitimab rilsodotin, upifitimab rilsodotin · Intervention Types: Drug, Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: every 6 weeks and then every 12 weeks until disease progression or start of a new therapy, assessed up to an average of 12 months.
Closest Location: Erlanger Womens Oncology · Chattanooga, TN
Photo of tennessee 1Photo of tennessee 2Photo of tennessee 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Carcinoma, Ovarian Epithelial
0 CompletedClinical Trials

Who is running the clinical trial?

Mersana TherapeuticsLead Sponsor
8 Previous Clinical Trials
1,124 Total Patients Enrolled
2 Trials studying Carcinoma, Ovarian Epithelial
168 Patients Enrolled for Carcinoma, Ovarian Epithelial
GOG FoundationNETWORK
26 Previous Clinical Trials
11,304 Total Patients Enrolled
9 Trials studying Carcinoma, Ovarian Epithelial
3,671 Patients Enrolled for Carcinoma, Ovarian Epithelial
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
27 Previous Clinical Trials
13,861 Total Patients Enrolled
15 Trials studying Carcinoma, Ovarian Epithelial
9,104 Patients Enrolled for Carcinoma, Ovarian Epithelial
Robert Burger, MDStudy DirectorMersana Therapeutics
2 Previous Clinical Trials
492 Total Patients Enrolled
1 Trials studying Carcinoma, Ovarian Epithelial
48 Patients Enrolled for Carcinoma, Ovarian Epithelial

Eligibility Criteria

Age 18+ · Female Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a histological diagnosis of high grade serous ovarian cancer, which includes fallopian tube and primary peritoneal cancer, that is metastatic or recurrent.
You have had as your best response to last line of treatment one of the following: No Evidence of Disease (NED); Complete Response (CR); Partial Response (PR); OR Stable Disease (SD).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.