Study on Vilastobart (XTX101) Alone and with Atezolizumab for Advanced Solid Tumors
Sponsor: Xilio Development, Inc.
ClinicalTrials ID:NCT04896697
This clinical trial is testing the safety and tolerability of a new drug, Vilastobart (XTX101), both on its own and in combination with another drug, Atezolizumab, in patients with advanced solid tumors.
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Program Overview
This study is the first to test Vilastobart (XTX101), a new drug designed to target cancer cells, in humans. It will look at how safe and tolerable Vilastobart is when used alone and when combined with Atezolizumab in patients with advanced solid tumors. The study is divided into different parts to explore various aspects of the treatment, including how it interacts with specific cancer markers and its effects on certain types of cancer, like metastatic colorectal cancer.
Description
This clinical trial is exploring a new cancer treatment using Vilastobart (XTX101), a drug that targets cancer cells, in patients with advanced solid tumors. The study is divided into several parts:
- Part 1A will test Vilastobart on its own to find the right dose.
- Part 1B will focus on how Vilastobart works with specific cancer markers in patients whose cancer has progressed after previous treatments.
- Part 1C will test Vilastobart in combination with Atezolizumab to find the best dose.
- Phase 2 will test the combination of Vilastobart and Atezolizumab in patients with a specific type of colorectal cancer that has spread and is stable in terms of genetic changes.
The study aims to determine the safety and effectiveness of these treatments in managing advanced cancers.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced or metastatic solid tumor that has not responded to standard treatments or for which no standard treatment is available.
- For Part 1B: Have a solid tumor that has progressed after treatment with anti-PD-1 or anti-PD-L1 therapy, or have specific types of cancer like prostate cancer, small cell lung cancer, or colorectal cancer that have progressed after previous treatments.
- For Phase 2: Have metastatic colorectal cancer that is stable in terms of genetic changes and has been treated with specific chemotherapy drugs.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have adequate organ function as determined by medical tests.
- For Parts 1B, 1C, and Phase 2: Have measurable disease according to specific criteria.
Exclusion Criteria
- Have received previous treatment with anti-CTLA-4 therapy.
- Have experienced severe side effects from previous immune-checkpoint therapy that lasted more than 6 weeks.
- Have received any cancer treatment within 4 weeks before starting the study.
- Have received radiation therapy within 2 weeks before starting the study.
- For Phase 2: Have received previous anti-PD-1/L1 therapy or any investigational checkpoint therapy.
- Have a diagnosis of immunodeficiency.
- Have another progressing cancer or one that required treatment in the past 3 years.
- Have an active autoimmune disease requiring treatment in the past 2 years.
- Have an active infection needing intravenous treatment within 4 weeks or oral treatment within 2 weeks before the study.
- Have a history of severe allergic reactions to any study drugs.
- Have a psychiatric or substance abuse disorder that would interfere with the study.
- For Phase 2: Have a symptomatic bowel obstruction.
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