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

Conditions

• Advanced Solid Tumor
• Chromosomal Instability
• Endometrium Cancer
• Head and Neck Squamous Cell Carcinoma
• High Grade Serous Adenocarcinoma of Ovary
• Ovarian Carcinosarcoma
• Squamous Non-small-cell Lung Cancer
• Triple Negative Breast Cancer
• Uterine Carcinosarcoma
• Uterine Serous Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• VLS-1488 — DRUG
  VLS-1488 tablets will be given orally.

Study Details

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.

Key Dates

Start date

Oct 18, 2023

Status verified

Oct 2025

Primary completion

Jun 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

200 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation: Dose Escalation Cohorts
  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.
• Experimental: Dose Escalation: Backfill Cohorts
  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.
• Experimental: Dose Expansion: Exploration Cohorts
  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.
• Experimental: Dose Expansion: Development Cohorts
  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.

Primary Outcome Measure

Dose Escalation: Incidence of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects [ Time Frame: Up to 12 months ]

Central Contacts

• Volastra Therapeutics, Inc.
  (646) 344-1248
  [email protected]

Locations (14)

Find similar trials in Los Angeles, CA

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