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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date June 2024
Source Volastra Therapeutics, Inc.
Contact Volastra Therapeutics, Inc.
Phone (646) 344-1248
Email clinicaltrials@volastratx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Sovilnesib
Sovilnesib tablets will be given orally.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Volastra Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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