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

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.

Conditions

Advanced Solid Tumor

Study Overview

Study Details

Study overview

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.

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

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

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Phoenix

Mayo Clinic Hospital, Phoenix, Arizona, United States, 85054

Duarte

City of Hope, Duarte, California, United States, 91010

Encinitas

California Cancer Associates for Research and Excellence, cCARE, Encinitas, California, United States, 92024

Irvine

City of Hope-Lennar, Irvine, California, United States, 92618

Los Angeles

USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90033

San Marcos

California Cancer Associates for Research and Excellence, cCARE, San Marcos, California, United States, 92069

Santa Monica

UCLA Hematology/Oncology- Santa Monica, Santa Monica, California, United States, 90404

Upland

City of Hope-Upland, Upland, California, United States, 91786

Jacksonville

Mayo Clinic Hospital, Jacksonville, Florida, United States, 32224

Orlando

Sarah Cannon Research Institute at Florida Cancer Specialists, Orlando, Florida, United States, 32827

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Xilio Development, Inc.,

Study Record Dates

2026-03-30