Sovilnesib for Ovarian Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of a new treatment called sovilnesib for people with high-grade serous ovarian cancer. Participants will receive varying doses of sovilnesib to determine the optimal dose for future studies. This trial targets individuals whose cancer has resisted or returned after platinum-based therapies and who may not have responded well to treatments like bevacizumab. Those battling this type of ovarian cancer and who have tried other treatments without success might find this trial suitable. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that sovilnesib is likely to be safe for humans?

Research has shown that sovilnesib may help treat ovarian cancer. In early human studies, 7 out of 17 patients with advanced ovarian cancer experienced tumor shrinkage after taking sovilnesib, suggesting potential benefits of the treatment.

Sovilnesib is taken once a day, and early studies aim to determine the optimal dose that is both effective and tolerable. Although detailed safety information is not fully provided here, participants in this early phase trial receive close monitoring to ensure safety, which is standard for new treatments tested in humans for the first time.

As with any clinical trial, researchers carefully observe participants for side effects to ensure safety. The goal is to find a dose that is effective while keeping side effects manageable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ovarian cancer?

Researchers are excited about sovilnesib for ovarian cancer because it offers a new approach by targeting specific molecular pathways that current treatments might not address. Unlike the standard of care options like chemotherapy, which attack both cancerous and healthy cells, sovilnesib is designed to selectively target cancer cells, potentially reducing side effects. This precision in targeting could mean more effective treatment outcomes and improved quality of life for patients.

What evidence suggests that sovilnesib might be an effective treatment for ovarian cancer?

Research has shown that sovilnesib could be a promising treatment for ovarian cancer. In an early study, sovilnesib, a drug that blocks a protein involved in cell division, reduced tumors in 7 out of 17 patients with advanced ovarian cancer. These patients had already tried several other treatments, highlighting sovilnesib's potential in difficult cases. In lab tests, sovilnesib reduced tumors without causing major side effects like weight loss. These findings suggest that sovilnesib might be a promising option for those with high-grade serous ovarian cancer. Participants in this trial will receive sovilnesib at different dose levels to evaluate its effectiveness and safety. ^{1 3 6 7 8}

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06084416

A Study of Sovilnesib in Subjects With Ovarian Cancer This is a randomized, phase 1b study to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of sovilnesib at different dose levels.

2. volastratx.com volastratx.com/initial-data-from-first-in-human-phase-i-ii-trial-of-novel-kif18a-inhibitor-vls-1488/

Volastra Announces Initial Data from First-in-Human Phase ... Novel once-daily oral KIF18A inhibitor demonstrated tumor reduction in 7 of 17 heavily pre-treated advanced ovarian cancer patients enrolled in dose escalation.

3. facingourrisk.org facingourrisk.org/research-clinical-trials/study/308/study-of-the-drug-sovilnesib-in-people-with-ovarian-cancer/printable

Study of the Drug Sovilnesib in People with Ovarian Cancer About the Study. This study will test the safety and effectiveness of the drug sovilnesib in patients with ovarian cancer. The study will be divided into two ...

4. veri.larvol.com veri.larvol.com/news/amg-650/drug

News - sovilnesib (AMG 650) Oral administration of 16 can induce a dose-dependent antitumor efficacy in the OVCAR-3 model without significant reduction in body weight. Compound 16 showed ...

5. amgentrials.com amgentrials.com/study/?id=20190131

Study of AMG 650 in Adult Participants with Advanced ... To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose ...

6. facingourrisk.org facingourrisk.org/research-clinical-trials/study/308/study-of-the-drug-sovilnesib-in-people-with-ovarian-cancer

Study of the Drug Sovilnesib in People with Ovarian Cancer This study will test the safety and effectiveness of the drug sovilnesib in patients with ovarian cancer. The study will be divided into two parts. Part 1: 10 ...

7. delta.larvol.com delta.larvol.com/Products/?ProductId=bf83cdf0-0c37-4e0e-be92-e14d2cae72ab

sovilnesib (AMG 650) / Amgen, BeOne Medicines, Volastra ... YF550 is a potent and selective inhibitor of KIF18A, specifically targeting CIN+ cancer cells (AACR 2025) - "In contrast to the Eg5 inhibitor Ispinesib, ...

8. aacrjournals.org aacrjournals.org/cancerres/article/83/7_Supplement/516/724129/Abstract-516-Discovery-and-preclinical

Discovery and preclinical characterization of AMG 650, a first ... Importantly, continuous once-daily dosing with AMG 650 shows robust anti-cancer activity with evidence of durable tumor regressions in a subset ...