RECRUITING

Vilastobart (XTX101) Monotherapy and Vilastobart and Atezolizumab Combination Therapy in Advanced Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety and tolerability of vilastobart (XTX101) as monotherapy and vilastobart (XTX101) and atezolizumab combination therapy in patients with advanced solid tumors.

Official Title

A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of Vilastobart (XTX101) Monotherapy and Vilastobart (XTX101) and Atezolizumab Combination Therapy in Patients with Advanced Solid Tumors

Quick Facts

Study Start:2021-09-13

Study Completion:2026-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04896697

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Part 1A and 1C: Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, or standard therapy is not curative or available; * Part 1B: * Any histologically or cytologically confirmed solid tumor malignancy for which anti-PD-1 or anti-PD-L1 treatment is approved and has progressed on or after prior anti-PD-1 or anti-PD-L1 therapy. * Patients with metastatic castrate-resistant prostate cancer if they have progressed on at least 2 lines of systemic therapy * Patients with extensive stage small cell lung cancer (SCLC) after at least 1 line of prior therapy * Patients with microsatellite stable colorectal cancer after at least 2 lines of prior therapy * Phase 2: Patients with histologically confirmed metastatic MSS CRC are eligible to enroll in Phase 2 as follows: * Patients must have had at least 1 prior chemotherapy regimen for metastatic CRC including all of the following agents: a fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab or biosimilars, an anti epidermal growth factor receptor antibody (cetuximab or panitumumab), and v-raf murine sarcoma viral oncogene homolog B1 inhibitor/BRAF (encorafenib), if applicable * Patients with MSI-H/dMMR are excluded * ECOG performance status of 0 or 1 * Adequate organ function * Part 1B, Part 1C, and Phase 2 only: measurable disease per iRECIST	* Received prior treatment with anti-CTLA-4 therapy * Received prior immune-checkpoint therapy and experienced Grade 3 or greater toxicity lasting greater than 6 weeks * Received prior systemic anticancer therapy within 4 weeks prior to study treatment * Received prior radiotherapy within 2 weeks prior to study treatment * Phase 2 only: Received prior anti-PD-1/L1 therapy or any investigational checkpoint inhibitory therapy * Has a diagnosis of immunodeficiency * Has known malignancy (other than disease under study) that is progressing or has required active treatment within the past 3 years * Has an active autoimmune disease that has required systemic treatment in past 2 years, including the use of disease modifying agents, corticosteroids or immunosuppressive drugs * Has an active infection requiring systemic intravenous therapy within 4 weeks prior to study treatment, or oral therapy within 2 weeks prior to study treatment * Has a history of severe hypersensitivity reaction (≥ Grade 3) to any study intervention and/or any of its excipients * Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study * Phase 2 only: symptomatic bowel obstruction

Inclusion Criteria

Exclusion Criteria

* Part 1A and 1C: Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, or standard therapy is not curative or available;
* Part 1B:
* Any histologically or cytologically confirmed solid tumor malignancy for which anti-PD-1 or anti-PD-L1 treatment is approved and has progressed on or after prior anti-PD-1 or anti-PD-L1 therapy.
* Patients with metastatic castrate-resistant prostate cancer if they have progressed on at least 2 lines of systemic therapy
* Patients with extensive stage small cell lung cancer (SCLC) after at least 1 line of prior therapy
* Patients with microsatellite stable colorectal cancer after at least 2 lines of prior therapy
* Phase 2: Patients with histologically confirmed metastatic MSS CRC are eligible to enroll in Phase 2 as follows:
* Patients must have had at least 1 prior chemotherapy regimen for metastatic CRC including all of the following agents: a fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab or biosimilars, an anti epidermal growth factor receptor antibody (cetuximab or panitumumab), and v-raf murine sarcoma viral oncogene homolog B1 inhibitor/BRAF (encorafenib), if applicable
* Patients with MSI-H/dMMR are excluded
* ECOG performance status of 0 or 1
* Adequate organ function
* Part 1B, Part 1C, and Phase 2 only: measurable disease per iRECIST

* Received prior treatment with anti-CTLA-4 therapy
* Received prior immune-checkpoint therapy and experienced Grade 3 or greater toxicity lasting greater than 6 weeks
* Received prior systemic anticancer therapy within 4 weeks prior to study treatment
* Received prior radiotherapy within 2 weeks prior to study treatment
* Phase 2 only: Received prior anti-PD-1/L1 therapy or any investigational checkpoint inhibitory therapy
* Has a diagnosis of immunodeficiency
* Has known malignancy (other than disease under study) that is progressing or has required active treatment within the past 3 years
* Has an active autoimmune disease that has required systemic treatment in past 2 years, including the use of disease modifying agents, corticosteroids or immunosuppressive drugs
* Has an active infection requiring systemic intravenous therapy within 4 weeks prior to study treatment, or oral therapy within 2 weeks prior to study treatment
* Has a history of severe hypersensitivity reaction (≥ Grade 3) to any study intervention and/or any of its excipients
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
* Phase 2 only: symptomatic bowel obstruction

Contacts and Locations

Study Contact

Xilio Medical Affairs

CONTACT

857-524-2466

medicalaffairs@xiliotx.com

Study Locations (Sites)

Mayo Clinic Hospital

Phoenix, Arizona, 85054

United States

City of Hope

Duarte, California, 91010

United States

California Cancer Associates for Research and Excellence, cCARE

Encinitas, California, 92024

United States

City of Hope-Lennar

Irvine, California, 92618

United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033

United States

California Cancer Associates for Research and Excellence, cCARE

San Marcos, California, 92069

United States

UCLA Hematology/Oncology- Santa Monica

Santa Monica, California, 90404

United States

City of Hope-Upland

Upland, California, 91786

United States

Mayo Clinic Hospital

Jacksonville, Florida, 32224

United States

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, 32827

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Mayo Clinic Hospital

Rochester, Minnesota, 55905

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

Carolina BioOncology Institute

Huntersville, North Carolina, 28078

United States

University of Pittsburgh Medical Center- Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

United States

Next Oncology

Austin, Texas, 78758

United States

Mary Crowley Cancer Research

Dallas, Texas, 75230

United States

Tranquil Clinical Research

Webster, Texas, 77598

United States

NEXT Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Xilio Development, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-13

Study Completion Date2026-03-30

Study Record Updates

Study Start Date2021-09-13

Study Completion Date2026-03-30

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor