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

ConditionsAdvanced Solid TumorHigh Grade Serous Adenocarcinoma of OvarySquamous Non-small-cell Lung CancerTriple Negative Breast CancerHead and Neck Squamous Cell CarcinomaOvarian CarcinosarcomaUterine CarcinosarcomaUterine Serous CarcinomaEndometrium CancerChromosomal Instability
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVolastra Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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%

Trial design

Design model

Sequential

Treatments tested in this trial

  • VLS-1488

    Drug

    VLS-1488 tablets will be given orally.

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Dose Escalation: Dose Escalation CohortsExperimental treatment 1 intervention
Group B: Dose Escalation: Backfill CohortsExperimental treatment 1 intervention
Group C: Dose Expansion: Exploration CohortsExperimental treatment 1 intervention
Group D: Dose Expansion: Development CohortsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose Escalation: Incidence of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects

Time frame
Up to 12 months
2

Dose Escalation: Determination of the MTD of VLS-1488

Time frame
Up to 12 months
3

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

Time frame
Up to 12 months
4

Dose Escalation: Frequency of Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0

Time frame
Up to 12 months

Secondary outcomes

1

Dose Escalation: ORR as assessed by RECIST version 1.1

Time frame
Up to 12 months
2

Dose Expansion: Frequency of SAEs graded according to NCI-CTCAE version 5.0

Time frame
Up to 18 months
3

Dose Expansion: Frequency of Treatment-related AEs graded according to NCI-CTCAE version 5.0

Time frame
Up to 18 months
4

Dose Expansion: Frequency of TEAEs graded according to NCI-CTCAE version 5.0

Time frame
Up to 18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Volastra Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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