Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Adenocarcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cystadenocarcinoma, Serous

Chromosomal Instability

Fallopian Tube Neoplasms

Cystadenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Fallopian Tube Diseases

Neoplasms, Cystic, Mucinous, and Serous

Chromosome Aberrations

Genomic Instability

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Adenocarcinoma of the Appendix

Subjects will receive sovilnesib once daily at Dose Level 1 in 28-day cycles.

Subjects will receive sovilnesib once daily at Dose Level 2 in 28-day cycles.

Subjects will receive sovilnesib once daily at Dose Level 3 in 28-day cycles.

Subjects will receive sovilnesib once daily at Dose Level 4 in 28-day cycles.

Sovilnesib

Volastra Therapeutics, Inc.

Joyce Liu, MD

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).

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.

A Study of Sovilnesib in Subjects With Ovarian Cancer

A Phase 1b Dose Optimization Study of Sovilnesib (an Oral KIF18A Inhibitor) in Subjects With Advanced High Grade Serous Ovarian Cancer

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Transitional Cell

Carcinoma, Squamous Cell

Lung Neoplasms

Urinary Bladder Neoplasms

Esophageal Squamous Cell Carcinoma

Carcinosarcoma

Mixed Tumor, Mullerian

Squamous Cell Carcinoma of Head and Neck

Adenoma, Pleomorphic

Endometrial Neoplasms

Neoplasms, Squamous Cell

Breast Diseases

Skin Diseases

Head and Neck Neoplasms

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Uterine Neoplasms

Uterine Diseases

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

Malignant Mixed Mullerian Tumor

Ovarian Carcinosarcoma

Uterine Carcinosarcoma

Esophageal Cancer

Soft Tissue Sarcoma

Subjects will be enrolled at various doses and/or schedules of VLS-1488. These Dose Escalation Cohorts will be utilized to identify the MTD and to select dose levels for Dose Expansion.

Additional subjects may be enrolled at any dose level that does not meet de-escalation or elimination rules per the BOIN design. These Backfill Cohorts will be utilized to build additional data to support selection of doses and/or tumor types for further study in Dose Expansion.

Subjects with a selected single tumor type will be randomized 1:1 into Exploration Cohorts at two or more dose levels of interest. A subset of subjects will have additional assessments to examine the potential for VLS-1488 to interact with other drugs and the effect of food on VLS-1488 absorption.

Subjects with other tumor types will be enrolled at a single dose level of interest. These Development Cohorts will be utilized to examine the preliminary efficacy of VLS-1488 in various tumor types.

VLS-1488

Yasmin Yazdani Farsad

Ingrid Palma

Megan Haas

Matthew Bark

Cancer AnswerLine

Abigail Van Kirk

Claire Friedman, MD

Abby Reed, RN

Emma Locke

Ecaterina Dumbrava, MD

This is a first-in-human phase I/II study to examine the safety, tolerability and preliminary efficacy of VLS-1488 in subjects with advanced cancers.

This a first-in-human phase I/II study designed to assess the safety, tolerability and preliminary efficacy of VLS-1488 monotherapy and consists of two parts: Dose Escalation and Dose Expansion.

Dose Escalation will examine the safety and tolerability of VLS-1488 in different solid tumor types at various dose levels through a series of Dose Escalation and Backfill Cohorts to identify the Maximum Tolerated Dose (MTD) and to select dose levels for Dose Expansion. The criteria for dose (de-)escalation will be based on a Bayesian Optimal Interval (BOIN) design.

Dose Expansion will examine the safety, tolerability, Drug Drug Interaction (DDI) risk, Food Effect (FE) and preliminary efficacy of VLS-1488 in different tumor types and/or dose levels of interest through various expansion cohorts.

VLS-1488 will be given orally in 28-day cycles. Dosing will be continued until disease progression, unacceptable toxicity, withdrawal of consent, or other stopping criteria are met.

A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer

A Phase I/II Study of VLS-1488 (an Oral KIF18A Inhibitor) in Subjects With Advanced Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Sovilnesib in Subjects With Ovarian Cancer	NCT06084416	High Grade Sero... Fallopian Tube ... Primary Periton... Chromosomal Ins...	Sovilnesib	18 Years -	Volastra Therapeutics, Inc.
A Study of Sovilnesib in Subjects With Ovarian Cancer	NCT06084416	High Grade Sero... Fallopian Tube ... Primary Periton... Chromosomal Ins...	Sovilnesib	18 Years -	Volastra Therapeutics, Inc.
A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer	NCT05902988	Advanced Solid ... High Grade Sero... Squamous Non-sm... Triple Negative... Gastric Adenoca... Colorectal Aden... Esophageal Squa... Esophageal Aden... Gastroesophagea... Transitional Ce... Head and Neck S... Ovarian Carcino... Uterine Carcino... Uterine Serous ... Endometrium Can... Chromosomal Ins...	VLS-1488	18 Years -	Volastra Therapeutics, Inc.

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