Trial Title:
A Phase I/II Study of VLS-1488 in Subjects with Advanced Cancer
NCT ID:
NCT05902988
Condition:
Advanced Solid Tumor
High Grade Serous Adenocarcinoma of Ovary
Squamous Non-small-cell Lung Cancer
Triple Negative Breast Cancer
Gastric Adenocarcinoma
Colorectal Adenocarcinoma
Esophageal Squamous Cell Carcinoma
Esophageal Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Transitional Cell Carcinoma of Bladder
Head and Neck Squamous Cell Carcinoma
Ovarian Carcinosarcoma
Uterine Carcinosarcoma
Uterine Serous Carcinoma
Endometrium Cancer
Chromosomal Instability
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Adenocarcinoma
Triple Negative Breast Neoplasms
Squamous Cell Carcinoma of Head and Neck
Esophageal Squamous Cell Carcinoma
Carcinoma, Transitional Cell
Cystadenocarcinoma, Serous
Carcinosarcoma
Mixed Tumor, Mullerian
Endometrial Neoplasms
Urinary Bladder Neoplasms
Chromosomal Instability
Conditions: Keywords:
KIF18A Inhibitor
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
VLS-1488
Description:
VLS-1488 tablets will be given orally.
Arm group label:
Dose Escalation: Backfill Cohorts
Arm group label:
Dose Escalation: Dose Escalation Cohorts
Arm group label:
Dose Expansion: Development Cohorts
Arm group label:
Dose Expansion: Exploration Cohorts
Summary:
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.
Detailed description:
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.
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
- Dose Escalation: No available therapeutic options to provide clinically meaningful
benefits in the following tumor types: High Grade Serous Ovarian Cancer, Squamous
Non -Small Cell Lung Cancer, Triple Negative Breast Cancer, Gastric Adenocarcinoma
(not EBV+), Colorectal, Esophageal Squamous Cell Carcinoma, Esophageal
Adenocarcinoma, Gastroesophageal Junction, Bladder (transitional cell), Head and
Neck Squamous Cell Carcinomas (not nasopharynx, sinonasal or lip), Ovarian
Carcinosarcoma, CN-high Endometrial/Uterine
- Dose Expansion: Must have been previously treated with several lines of standard of
care treatment specified in the protocol in the following tumor types: High Grade
Serous Ovarian Cancer, Squamous Non-Small Cell Lung Cancer, Triple Negative Breast
Cancer, Gastric Adenocarcinoma (not EBV+), Colorectal, Esophageal Squamous Cell
Carcinoma, Esophageal Adenocarcinoma, Head and Neck Squamous Cell Carcinomas (not
nasopharynx, sinonasal or lip), CN-high Endometrial/Uterine
Key Exclusion Criteria:
- MSI-H, dMMR, POLE gene hotspot mutated, or known hypermutator phenotype
- Previously received KIF18A inhibitor
- Current CNS metastases or leptomeningeal disease
- Cardiac parameters: MI or stroke ≤ 1 year, unstable angina/PE/DVT/CABG ≤ 6 months,
NYHA Class ≥ II, LVEF < 50%
- Inability to comply with concomitant medication restrictions with respect to strong
inhibitors and inducers of CYP3A, and clinical inhibitors of MDR1 (P-gp) and BCRP
- Any clinically significant ascites or pleural effusions at time of enrollment, or
any therapeutic paracentesis or thoracentesis within 28 days of planned first dose
of study drug
- Bowel obstruction or GI perforation within 6 months of planned first dose of study
drug
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Southern California
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Xiomara Menendez, RN
Email:
Xiomara.Menendez@med.usc.edu
Contact backup:
Last name:
Lorraine Martinez, MD
Email:
Lorraine.Martinez@med.usc.edu
Contact backup:
Last name:
Jacob Thomas, MD
Facility:
Name:
University of Colorado Cancer Center
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yasmin Yazdani Farsad
Phone:
303-724-9403
Email:
YASMIN.YAZDANIFARSAD@CUANSCHUTZ.EDU
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06511
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ingrid Palma
Phone:
203-833-1034
Email:
ingrid.palma@yale.edu
Facility:
Name:
Community Health Network
Address:
City:
Indianapolis
Zip:
46256
Country:
United States
Status:
Recruiting
Contact:
Last name:
Megan Haas
Email:
mhaas2@ecommunity.com
Facility:
Name:
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Address:
City:
Baltimore
Zip:
21224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Matthew Bark
Phone:
443-927-8743
Email:
Mbark1@jhmi.edu
Facility:
Name:
University of Michigan
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cancer AnswerLine
Phone:
800-865-1125
Email:
CancerAnswerLine@med.umich.edu
Facility:
Name:
START Midwest
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Contact:
Last name:
Abigail Van Kirk
Phone:
616-389-1824
Email:
Abigail.vankirk@startmidwest.com
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Claire Friedman, MD
Phone:
646-888-4593
Email:
friedmac@mskcc.org
Facility:
Name:
The Christ Hospital
Address:
City:
Cincinatti
Zip:
45219
Country:
United States
Status:
Recruiting
Contact:
Last name:
Abby Reed, RN
Phone:
513-585-1140
Email:
abby.reed@thechristhospital.com
Facility:
Name:
Women & Infants Hospital
Address:
City:
Providence
Zip:
02905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Emma Locke
Phone:
401-430-8181
Email:
oncologyresearch@wihri.org
Facility:
Name:
M.D. Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ecaterina Dumbrava, MD
Phone:
713-792-3934
Email:
eeileana@mdanderson.org
Start date:
October 18, 2023
Completion date:
June 2026
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/NCT05902988
