Esophageal Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT05902988

Recruitment Status:

Recruiting

Sponsor:

Volastra Therapeutics, Inc.

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There are 10 Locations for this study

See Locations Near You

University of Colorado Cancer Center
Aurora Colorado, 80045, United States More Info
Yasmin Yazdani Farsad
Contact
303-724-9403
[email protected]
Yale Cancer Center
New Haven Connecticut, 06511, United States More Info
Ingrid Palma
Contact
203-833-1034
[email protected]
Community Health Network
Indianapolis Indiana, 46256, United States More Info
Megan Haas
Contact
[email protected]
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore Maryland, 21224, United States More Info
Matthew Bark
Contact
443-927-8743
[email protected]
University of Michigan
Ann Arbor Michigan, 48109, United States More Info
Cancer AnswerLine
Contact
800-865-1125
[email protected]
START Midwest
Grand Rapids Michigan, 49546, United States More Info
Abigail Van Kirk
Contact
616-389-1824
[email protected]
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Claire Friedman, MD
Contact
646-888-4593
[email protected]
The Christ Hospital
Cincinnati Ohio, 45219, United States More Info
Abby Reed, RN
Contact
513-585-1140
[email protected]
Women & Infants Hospital
Providence Rhode Island, 02905, United States More Info
Emma Locke
Contact
401-430-8181
[email protected]
M.D. Anderson Cancer Center
Houston Texas, 77030, United States More Info
Ecaterina Dumbrava, MD
Contact
713-792-3934
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT05902988

Recruitment Status:

Recruiting

Sponsor:


Volastra Therapeutics, Inc.

How clear is this clinincal trial information?

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