Vilastobart (XTX101) Monotherapy and Vilastobart and Atezolizumab Combination Therapy in Advanced Solid Tumors
NCT ID: NCT04896697
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
136 participants
INTERVENTIONAL
2021-09-13
2026-03-30
Brief Summary
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Detailed Description
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Part 1A will examine vilastobart (XTX101) monotherapy in an accelerated and standard 3+3 dose escalation design. Based on the results of Part 1A, patients with select advanced solid tumors will be enrolled in Part 1B, which will evaluate vilastobart (XTX101) monotherapy in relation to specific PD biomarkers.
Part 1C will examine vilastobart (XTX101) in combination with atezolizumab in a standard 3+3 dose escalation/dose de-escalation design. Part 1C may include a dose expansion cohort to further evaluate the safety, PK, and PD of dose levels that were previously cleared.
Phase 2 will examine vilastobart (XTX101) in combination with atezolizumab in patients with metastatic microsatellite stable colorectal cancer (MSS CRC) at the RP2D(s) defined in Part 1C.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1A - vilastobart (XTX101) Monotherapy Dose Escalation
Part 1A Dose Escalation of vilastobart (XTX101) administered in ascending doses to patients with advanced or metastatic solid tumors to find the recommended phase 2 dose (RP2D).
vilastobart (XTX101)
vilastobart (XTX101) monotherapy
Part 1B - Pharmacodynamic (PD) Dose Expansion
Part 1B vilastobart (XTX101) at the RP2D will be administered to further examine vilastobart (XTX101) as monotherapy in patients with select advanced solid tumors.
vilastobart (XTX101)
vilastobart (XTX101) monotherapy
Part 1C - vilastobart (XTX101) Dose Escalation and Dose Expansion in Combination with Atezolizumab
Part 1C will receive a labeled dose of atezolizumab in combination with vilastobart (XTX101).
Atezolizumab
1200 mg administered every 3 weeks in combination with vilastobart (XTX101)
vilastobart (XTX101)
In combination with Atezolizumab
Phase 2 - vilastobart (XTX101) Dose Expansion in Combination with Atezolizumab
Phase 2 will receive a labeled dose of atezolizumab in combination with vilastobart (XTX101) at the RP2D(s) in patients with MSS CRC.
Atezolizumab
1200 mg administered every 3 weeks in combination with vilastobart (XTX101)
vilastobart (XTX101)
In combination with Atezolizumab
Interventions
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vilastobart (XTX101)
vilastobart (XTX101) monotherapy
Atezolizumab
1200 mg administered every 3 weeks in combination with vilastobart (XTX101)
vilastobart (XTX101)
In combination with Atezolizumab
Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Xilio Development, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
References
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Jenkins KA, Park M, Pederzoli-Ribeil M, Eskiocak U, Johnson P, Guzman W, McLaughlin M, Moore-Lai D, O'Toole C, Liu Z, Nicholson B, Flesch V, Qiu H, Clackson T, O'Hagan RC, Rodeck U, Karow M, O'Neil J, Williams JC. XTX101, a tumor-activated, Fc-enhanced anti-CTLA-4 monoclonal antibody, demonstrates tumor-growth inhibition and tumor-selective pharmacodynamics in mouse models of cancer. J Immunother Cancer. 2023 Dec 12;11(12):e007785. doi: 10.1136/jitc-2023-007785.
Other Identifiers
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XTX101-01/02-001
Identifier Type: -
Identifier Source: org_study_id
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