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New pill shows promise for Hard-to-Treat ovarian cancer

NCT ID NCT06084416

Disease control Sponsor: Volastra Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 1b trial tests an experimental oral drug called sovilnesib in 120 people with advanced high-grade serous ovarian cancer that has stopped responding to standard platinum chemotherapy. The goal is to find the safest and most effective dose while monitoring side effects and tumor response. Participants take sovilnesib tablets by mouth, and the study will measure how well the drug controls the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sovilnesib (an oral KIF18A inhibitor)
What this could lead to
If successful, this could lead to a new oral treatment option for advanced ovarian cancer that has stopped responding to platinum-based chemotherapy.
What could go wrong
This is an early phase 1b trial with only 120 participants, so the drug may not prove effective or may have significant side effects. It is not a cure and aims to control the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * All Parts: Age ≥ 18 years, ECOG Performance Status ≤ 1, at least 1 site of measurable disease evaluable by CT scan or MRI per RECIST 1.1, able to take oral medication without alteration * High Grade Serous Ovarian Cancer, Fallopian Tube or Primary Peritoneal Cancer - histologically or cytologically confirmed; metastatic or unresectable; platinum resistant (defined as recurrence within 6 months of platinum containing therapy) or platinum refractory; prior bevacizumab treatment, or ineligible or intolerant to bevacizumab, or did not receive bevacizumab based on Investigator judgement; if germline and/or somatic BRCA1/2 mutation, previously treated with PARP-inhibitor or ineligible or intolerant. Key Exclusion Criteria: * MSI-H, dMMR, POLE gene hotspot mutated, or known hypermutator phenotype * Endometrioid, clear cell, mucinous, sarcomatoid, low-grade/borderline ovarian tumor or mixed tumors containing any of the above histologies * Previously received KIF18A inhibitor * Current CNS metastases or leptomeningeal disease * Cardiac parameters: MI or stroke ≤ 6 months, unstable angina/PE/DVT/CABG ≤ 6 months, NYHA Class ≥ II, LVEF \< 50% * Any gastrointestinal condition (e.g. malabsorption syndrome, surgical anastomosis, short bowel syndrome) that might affect the absorption of oral medications including the study drug

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Conditions

The condition(s) this trial relates to.

Chromosomal Instability fallopian tube cancer fallopian tube neoplasm ovarian serous adenocarcinoma primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chromosomal instability Fallopian tube cancer High grade serous adenocarcinoma of ovary Primary peritoneal carcinoma

Contacts and locations

Locations

  • Corewell Health

    Grand Rapids, Michigan, 49503, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Georgia Cancer Center Augusta University

    Atlanta, Georgia, 30912, United States

  • Hoag Memorial Hospital

    Newport Beach, California, 92663, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10128, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • MUSC Hollings Cancer Center

    Charleston, South Carolina, 29020, United States

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73117, United States

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263, United States

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • UCLA

    Los Angeles, California, 90095, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

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