Recruiting at 4 sites Phase 1 High Grade Serous Adenocarcinoma of Ovary

High Grade Serous Adenocarcinoma of Ovary study: Sovilnesib

Official title A Study of Sovilnesib in Subjects With Ovarian Cancer

ClinicalTrials.gov ID: NCT06084416

What this study is testing

What is Sovilnesib?

Sovilnesib is an investigational medicine, taken by mouth, being studied as a potential treatment for high grade serous adenocarcinoma of ovary.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study aims to find the best dose of the drug and check if it is safe and works.
Who it's for
People with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
What's involved
Participants will receive sovilnesib and undergo tests to monitor how their body handles the drug.
Time commitment
The duration and specific visit schedule are not listed in the provided text.
  • Phase 1: an early, usually small safety study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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...
  • Histologically confirmed locally advanced, inoperable, or metastatic tumor.
  • High Grade Serous Ovarian Cancer, Fallopian Tube or Primary Peritoneal Cancer - histologically confirmed; locally advanced, inoperable or metastatic

You likely can't join if

  • Part 1 only: 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
  • Leptomeningeal disease, or new or progressive CNS metastases or spinal cord compression
  • Cardiac parameters: MI, PE, CABG, severe/unstable angina or stroke ≤ 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...

The study team makes the final eligibility decision.

Where it is enrolling

  • Birmingham, Alabama, United States
  • Atlanta, Georgia, United States
  • Buffalo, New York, United States
  • Oklahoma City, Oklahoma, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Birmingham, Alabama, United States; Atlanta, Georgia, United States; Buffalo, New York, United States; Oklahoma City, Oklahoma, United States. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.