Trial Title:
A Study of Sovilnesib in Subjects with Ovarian Cancer
NCT ID:
NCT06084416
Condition:
High Grade Serous Adenocarcinoma of Ovary
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Chromosomal Instability
Conditions: Official terms:
Fallopian Tube Neoplasms
Cystadenocarcinoma, Serous
Chromosomal Instability
Conditions: Keywords:
KIF18A Inhibitor
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sovilnesib
Description:
Sovilnesib tablets will be given orally.
Arm group label:
Dose Level 1
Arm group label:
Dose Level 2
Arm group label:
Dose Level 3
Arm group label:
Dose Level 4
Summary:
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).
Detailed description:
This is a randomized, phase 1b dose optimization study of sovilnesib in subjects with
platinum-resistant HGSOC. The focus of the proposed clinical study is to establish the
RP2D of sovilnesib in HGSOC.
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 2 parts.
Part 1: 10 subjects will be randomized to each of the open dose levels to generate
preliminary PK, pharmacodynamic (PD), safety, tolerability and efficacy data. Early
stopping rules for safety based on a Bayesian Toxicity Monitoring Design will be applied.
Part 2: Based on review of the data from Part 1, 20-30 additional subjects will be
randomized to 2 or more dose levels examined in Part 1. At the end of Part 2, PK, PD,
safety, tolerability and efficacy data will be used to determine the RP2D. 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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Arkansas for Medical Sciences
Address:
City:
Little Rock
Zip:
72205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Maroof K Zafar, PhD
Phone:
501-686-8274
Phone ext:
24576
Email:
mkzafar@uams.edu
Contact backup:
Last name:
Aaron Holley
Email:
JAHolley@uams.edu
Facility:
Name:
UCLA
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stacy Zamora, MS
Phone:
310-562-8933
Email:
SAZamora@mednet.ucla.edu
Facility:
Name:
Hoag Memorial Hospital
Address:
City:
Newport Beach
Zip:
92663
Country:
United States
Status:
Recruiting
Contact:
Last name:
Patrice Jones
Phone:
9497645501
Email:
patrice.jones@hoag.org
Facility:
Name:
Georgia Cancer Center Augusta University
Address:
City:
Atlanta
Zip:
30912
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gwendolyn Stanley, RN
Phone:
706-721-3473
Email:
gstanley@augusta.edu
Facility:
Name:
Johns Hopkins Hospital
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
Johns Hopkins
Phone:
410-614-1361
Email:
HopkinsGynTrials@jhmi.edu
Contact backup:
Last name:
Stephanie Gaillard, MD PhD
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Joyce Liu, MD
Phone:
877-338-7425
Facility:
Name:
Corewell Health
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Esther Peariso, MSN, RN, NI-BC, CCRC
Phone:
616-486-0358
Email:
esther.peariso@corewellhealth.org
Contact backup:
Last name:
Gregory Gressel, MD
Facility:
Name:
Roswell Park Comprehensive Cancer Center
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Contact:
Last name:
ASK-RPCI
Phone:
1-877-245-7724
Email:
askroswell@roswellpark.org
Facility:
Name:
Icahn School of Medicine at Mount Sinai
Address:
City:
New York
Zip:
10128
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neha Kumarley, MPH, CCRC
Phone:
212-824-7859
Email:
neha.kumarley@mssm.edu
Facility:
Name:
OU Health Stephenson Cancer Center
Address:
City:
Oklahoma City
Zip:
73117
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christine Pappaterra
Phone:
405-271-8707
Email:
christine-pappaterra@ouhsc.edu
Facility:
Name:
MUSC Hollings Cancer Center
Address:
City:
Charleston
Zip:
29020
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carly Fecio, MPH
Phone:
843-792-9300
Email:
fecio@musc.edu
Contact backup:
Phone:
843-792-9300
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gyn Research
Email:
GynResearch@fredhutch.org
Start date:
April 4, 2024
Completion date:
July 2025
Lead sponsor:
Agency:
Volastra Therapeutics, Inc.
Agency class:
Industry
Source:
Volastra Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06084416
