A Study of Sovilnesib in Subjects With Ovarian Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Volastra Therapeutics, Inc.
Study ID
NCT06084416
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Chromosomal Instability
  • Fallopian Tube Cancer
  • High Grade Serous Adenocarcinoma of Ovary
  • Primary Peritoneal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sovilnesib — DRUG
    Sovilnesib tablets will be given orally.

Study Details

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.

Key Dates

First listed
Oct 16, 2023
Start date
Apr 4, 2024
Status verified
Oct 2026
Primary completion
Nov 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1
    Subjects will receive sovilnesib once daily at Dose Level 1 in 28-day cycles.
  • Experimental: Dose Level 2
    Subjects will receive sovilnesib once daily at Dose Level 2 in 28-day cycles.
  • Experimental: Dose Level 3
    Subjects will receive sovilnesib once daily at Dose Level 3 in 28-day cycles.
  • Experimental: Dose Level 4
    Subjects will receive sovilnesib once daily at Dose Level 4 in 28-day cycles.

Primary Outcome Measure

Determination of the Recommended Phase 2 Dose (RP2D) of Sovilnesib [ Time Frame: Up to 24 months ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
The University of Alabama at BirminghamBirminghamAlabama35294
Charles A. Leath, III, MD
205-934-4986
University of Arkansas for Medical SciencesLittle RockArkansas72205-
Hoag Memorial HospitalNewport BeachCalifornia92663-
Georgia Cancer Center Augusta UniversityAtlantaGeorgia30912
Gwendolyn Stanley, RN
[email protected]
706-721-3473
Johns Hopkins HospitalBaltimoreMaryland21287-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263
ASK-RPCI
[email protected]
877-245-7724
Icahn School of Medicine at Mount SinaiNew YorkNew York10128-
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73117
Christine Pappaterra
[email protected]
405-271-8707
MUSC Hollings Cancer CenterCharlestonSouth Carolina29020-
Fred Hutchinson Cancer CenterSeattleWashington98109-

Find similar trials in Birmingham, AL

By research site
The University of Alabama at Birmingham· Birmingham, ALUniversity of Arkansas for Medical Sciences· Little Rock, ARHoag Memorial Hospital· Newport Beach, CAGeorgia Cancer Center Augusta University· Atlanta, GAJohns Hopkins Hospital· Baltimore, MDDana Farber Cancer Institute· Boston, MA

Related Studies