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

Completed · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor

In brief

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.

Key facts

Study ID

NCT04896697

Run by

Xilio Development, Inc.

People needed

125

Starts

2021-09-13

Expected to finish

2026-05-18

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Disease 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

You may not qualify if…

• 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 approved 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

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• City of Hope — Duarte, California, United States
• California Cancer Associates for Research and Excellence, cCARE — Encinitas, California, United States
• City of Hope-Lennar — Irvine, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• California Cancer Associates for Research and Excellence, cCARE — San Marcos, California, United States
• UCLA Hematology/Oncology- Santa Monica — Santa Monica, California, United States
• City of Hope-Upland — Upland, California, United States
• Mayo Clinic Hospital — Jacksonville, Florida, United States
• Sarah Cannon Research Institute at Florida Cancer Specialists — Orlando, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mayo Clinic Hospital — Rochester, Minnesota, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Carolina BioOncology Institute — Huntersville, North Carolina, United States
• University of Pittsburgh Medical Center- Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Next Oncology — Austin, Texas, United States
• Mary Crowley Cancer Research — Dallas, Texas, United States
• Tranquil Clinical Research — Webster, Texas, United States
• NEXT Virginia — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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