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VLS-1488 for Advanced Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Volastra Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For Dose Escalation: No available therapeutic options to provide clinically meaningful benefits in specific tumor types

ECOG Performance Status ≤ 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 32 months

Awards & highlights

Study Summary

This trial tests a new cancer drug to see if it's safe, effective, and tolerable.

Who is the study for?

This trial is for adults with advanced cancers who've already tried standard treatments. They should be able to perform daily activities with minimal assistance (ECOG ≤ 1), have measurable disease, and take pills without changing them. Not eligible if they have certain genetic mutations, brain metastases, previous KIF18A inhibitor treatment, or recent serious heart issues.Check my eligibility

What is being tested?

The study tests VLS-1488's safety and early effectiveness in patients with various advanced cancers. It includes two parts: dose escalation to find the right amount of drug and dose expansion to see how well it works at that dose.See study design

What are the potential side effects?

As this is a first-in-human study for VLS-1488, specific side effects are not yet known but may include typical reactions related to cancer drugs such as nausea, fatigue, allergic reactions or more serious complications depending on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have no other treatment options that would significantly help my cancer.

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I am fully active or can carry out light work.

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I can swallow pills without needing to crush or dissolve them.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 32 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 32 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 32 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Escalation: Determination of the MTD of VLS-1488

Dose Escalation: Frequency of Dose Interruptions and Permanent Treatment Discontinuations

Dose Escalation: Frequency of Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0

+5 more

Secondary outcome measures

Dose Escalation & Dose Expansion: AUC of VLS-1488

Dose Escalation & Dose Expansion: Cmax of VLS-1488

Dose Escalation & Dose Expansion: Disease Control Rate (DCR) as assessed by RECIST version 1.1

+16 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose Expansion: Exploration CohortsExperimental Treatment1 Intervention

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.

Group II: Dose Expansion: Development CohortsExperimental Treatment1 Intervention

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.

Group III: Dose Escalation: Dose Escalation CohortsExperimental Treatment1 Intervention

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.

Group IV: Dose Escalation: Backfill CohortsExperimental Treatment1 Intervention

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.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Volastra Therapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

186 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for enrolment in the current study?

"As per records on clinicaltrials.gov, this trial is presently recruiting for participants and was updated as recently as October 30th 2023. Its inception dates back to October 18th 2023."

Answered by AI

How many participants are being observed during this clinical research?

"Indeed, the information available on clinicaltrials.gov attests that this research is recruiting participants. Originally uploaded to the website on October 18th 2023, the trial seeks a total of 120 enrollees from two distinct locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05902988.

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