Fallopian Tube Cancer Clinical Trial
Official title:
A Phase 1b Dose Optimization Study of Sovilnesib (an Oral KIF18A Inhibitor) in Subjects With Advanced High Grade Serous Ovarian Cancer
NCT number | NCT06084416 |
Other study ID # | SOVI-2302 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | April 4, 2024 |
Est. completion date | July 2025 |
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).
Status | Recruiting |
Enrollment | 120 |
Est. completion date | July 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Hoag Memorial Hospital | Newport Beach | California |
United States | Fred Hutchinson Cancer Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Volastra Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determination of the Recommended Phase 2 Dose (RP2D) of Sovilnesib | Up to 24 months | ||
Primary | 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 | Up to 24 months | ||
Primary | Frequency and duration of Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0 | Up to 24 months | ||
Primary | Frequency and duration of Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0 | Up to 24 months | ||
Primary | Frequency of Dose Interruptions and Permanent Treatment Discontinuations | Up to 24 months | ||
Primary | Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | Up to 24 months | ||
Secondary | Duration of Response (DOR) as assessed by RECIST version 1.1 | Up to 24 months | ||
Secondary | Disease Control Rate (DCR) as assessed by RECIST version 1.1 | Up to 24 months | ||
Secondary | Progression Free Survival (PFS) as assessed by RECIST version 1.1 | Up to 24 months | ||
Secondary | Evaluation of CA-125 response by Gynecologic Cancer InterGroup (GCIG) criteria | Up to 24 months | ||
Secondary | Plasma level of Sovilnesib | Up to 24 months |
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