Sovilnesib for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a randomized, phase 1b study to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of sovilnesib at different dose levels to establish the Recommended Phase 2 Dose (RP2D) of sovilnesib in subjects with high grade serous ovarian cancer (HGSOC).
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Are You a Good Fit for This Trial?
This trial is for adults over 18 with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer that's metastatic or can't be surgically removed. They should have tried platinum-based therapy but had the cancer return within 6 months or didn't respond to it at all. Participants may have had prior treatments like bevacizumab unless they're intolerant or ineligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
10 subjects are randomized to each of the open dose levels to generate preliminary PK, PD, safety, tolerability, and efficacy data
Treatment Part 2
20-30 additional subjects are randomized to 2 or more dose levels examined in Part 1 to determine the RP2D
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sovilnesib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Volastra Therapeutics, Inc.
Lead Sponsor