Sovilnesib for Ovarian Cancer

Recruiting at 12 trial locations

Overseen By Volastra Therapeutics, Inc.

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Volastra Therapeutics, Inc.

Disqualifiers: CNS metastases, Cardiac issues, Gastrointestinal conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

Trial Summary

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.

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).

Eligibility Criteria

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

I am fully active or can carry out light work.

I have at least one tumor that can be measured on a CT scan or MRI.

I can swallow pills without needing to change them.

Exclusion Criteria

I have been treated with a KIF18A inhibitor before.

My cancer has spread to my brain or spinal cord.

I have a condition that affects how my body absorbs pills.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

10 subjects are randomized to each of the open dose levels to generate preliminary PK, PD, safety, tolerability, and efficacy data

28-day cycles

Multiple visits as per cycle

Treatment Part 2

20-30 additional subjects are randomized to 2 or more dose levels examined in Part 1 to determine the RP2D

28-day cycles

Multiple visits as per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sovilnesib

Trial Overview The study tests different doses of Sovilnesib to find a safe and effective level for phase 2 trials in patients with advanced ovarian cancer. It's randomized, meaning participants are put into groups by chance to receive varying doses and their responses are compared.

Participant Groups

Group I: Dose Level 4 Experimental Treatment 1 Intervention

Subjects will receive sovilnesib once daily at Dose Level 4 in 28-day cycles.

Group II: Dose Level 3 Experimental Treatment 1 Intervention

Subjects will receive sovilnesib once daily at Dose Level 3 in 28-day cycles.

Group III: Dose Level 2 Experimental Treatment 1 Intervention

Subjects will receive sovilnesib once daily at Dose Level 2 in 28-day cycles.

Group IV: Dose Level 1 Experimental Treatment 1 Intervention

Subjects will receive sovilnesib once daily at Dose Level 1 in 28-day cycles.

Who Is Running the Clinical Trial?

Volastra Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

310+