High Grade Serous Adenocarcinoma of OvaryPhase 1NCT06084416
A Study of Sovilnesib in Subjects With Ovarian Cancer
A Phase 1 study testing Sovilnesib in people with High Grade Serous Adenocarcinoma of Ovary and Fallopian Tube Cancer, run by Volastra Therapeutics, Inc. at 11 sites in United States.
Trial summary
This is a phase 1b study to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of sovilnesib at different dose levels to establish the optimal dose of sovilnesib in subjects with selected advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Serous Adenocarcinoma of Ovary, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- What is being tested?
- Sovilnesib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 11 sitesUnited States
- Study dates
- 4 Apr 2024to Dec 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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; p16 positive (Part 2 only); platinum resistant (defined as radiographic progression/recurrence <180 days after last dose of ≥ 4 cycles of platinum containing therapy) or refractory; prior bevacizumab treatment, unless ineligible or intolerant; if germline and/or somatic BRCA1/2 mutation, previously treated with PARP-inhibitor (unless ineligible or intolerant).
Who cannot join
- 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 medications including the study drug
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 4 recruiting
- Recruiting
Georgia Cancer Center Augusta University
Atlanta, Georgia, 30912
Gwendolyn Stanley, RN, 706-721-3473, gstanley@augusta.edu
- Active, not recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
- Recruiting
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Charles A. Leath, III, MD, 205-934-4986
- Active, not recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
ASK-RPCI, 877-245-7724, askroswell@roswellpark.org
- Active, not recruiting
MUSC Hollings Cancer Center
Charleston, South Carolina, 29020
- Active, not recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
- Active, not recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10128
- Active, not recruiting
Hoag Memorial Hospital
Newport Beach, California, 92663
- Recruiting
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73117
Christine Pappaterra, 405-271-8707, christine-pappaterra@ouhsc.edu
- Active, not recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
About this study
Official title: A Phase 1b Dose Optimization Study of Sovilnesib (an Oral KIF18A Inhibitor) in Subjects With Selected Advanced Solid Tumors
This is a phase 1b study to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of sovilnesib at different dose levels to establish the optimal dose of sovilnesib in subjects with selected advanced solid tumors.
Read the detailed description
This is a phase 1b study of sovilnesib in subjects with advanced solid tumors. The focus of the proposed clinical study is to establish the optimal dose of sovilnesib for further clinical development.
An adaptive multi-cohort design will be used to assess the safety, tolerability, PK, and efficacy of multiple dose levels in parallel to establish the RP2D of sovilnesib.
The study will be conducted in two parts: Part 1 and Part 2. Part 1 is a randomized dose optimization phase in the biomarker-unselected platinum resistant HGSOC patient population. Part 2 is a randomized dose optimization phase in the p16 positive (biomarker-selected) platinum resistant HGSOC patient population. Depending on the emerging data of the Part 1 dose optimization stage, consideration will be given to initiate sub-study cohort(s) in other selected locally advanced or metastatic tumor types to provide additional safety, PK/PD and preliminary efficacy data. Early stopping rules for safety based on a Bayesian Toxicity Monitoring Design and for futility based on a Bayesian Efficacy Monitoring via Predictive Probability Design will be applied.
Sovilnesib will be given orally in 28-day cycles at selected dose levels of interest. Dosing will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other stopping criteria are met.
- Conditions
- High Grade Serous Adenocarcinoma of Ovary, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Chromosomal Instability
- Being tested
- Sovilnesib
- Keywords
- KIF18A Inhibitor
- Medical subject headings
- Fallopian Tube Neoplasms, Chromosomal Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SovilnesibDrug
Sovilnesib tablets will be given orally.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | Subjects will receive sovilnesib once daily at Dose Level 1 in 28-day cycles. Receives: Drug: Sovilnesib |
| Dose Level 2 | Experimental | Subjects will receive sovilnesib once daily at Dose Level 2 in 28-day cycles. Receives: Drug: Sovilnesib |
| Dose Level 3 | Experimental | Subjects will receive sovilnesib once daily at Dose Level 3 in 28-day cycles. Receives: Drug: Sovilnesib |
| Dose Level 4 | Experimental | Subjects will receive sovilnesib once daily at Dose Level 4 in 28-day cycles. Receives: Drug: Sovilnesib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the Recommended Phase 2 Dose (RP2D) of Sovilnesib
Measured: Up to 24 months
Frequency and duration of Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Measured: Up to 24 months
Frequency and duration of Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0
Measured: Up to 24 months
Frequency and duration of Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0
Measured: Up to 24 months
Frequency of Dose Interruptions and Permanent Treatment Discontinuations
Measured: Up to 24 months
Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Up to 24 months
Secondary outcomes (6)
Duration of Response (DOR) as assessed by RECIST version 1.1
Measured: Up to 24 months
Disease Control Rate (DCR) as assessed by RECIST version 1.1
Measured: Up to 24 months
Progression Free Survival (PFS) as assessed by RECIST version 1.1
Measured: Up to 24 months
Evaluation of CA-125 response by Gynecologic Cancer InterGroup (GCIG) criteria
Measured: Up to 24 months
Overall Survival (OS) (Part 2 only)
Measured: Up to 24 months
Plasma level of Sovilnesib
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start4 Apr 2024
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade Serous Adenocarcinoma of OvaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Volastra Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084416
- Sponsor's protocol ID
- SOVI-2302
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided