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NCT04896697

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

Recruiting now Phase 1, PHASE2 Last updated 29 May 2025
What this trial tests

Phase 1, PHASE2 trial testing vilastobart (XTX101) in Advanced Solid Tumor in 136 participants. Currently enrolling.

Timeline
13 September 2021
Primary endpoint
30 March 2026
30 March 2026

Quick facts

Lead sponsorXilio Development, Inc.
PhasePhase 1, PHASE2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment136
Start date13 September 2021
Primary completion30 March 2026
Estimated completion30 March 2026
Sites19 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Xilio Development, Inc. — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immune evasion in cancer: mechanisms and cutting-edge therapeutic approaches.
    Tufail M, Jiang CH, Li N. · · 2025 · cited 82× · PMID 40739089 · DOI 10.1038/s41392-025-02280-1
  2. Exploiting protease activation for therapy.
    Bleuez C, Koch WF, Urbach C, Hollfelder F, et al · · 2022 · cited 27× · PMID 35314338 · DOI 10.1016/j.drudis.2022.03.011
  3. The basic biology of NK cells and its application in tumor immunotherapy.
    Jiang P, Jing S, Sheng G, Jia F. · · 2024 · cited 17× · PMID 39221244 · DOI 10.3389/fimmu.2024.1420205
  4. XTX101, a tumor-activated, Fc-enhanced anti-CTLA-4 monoclonal antibody, demonstrates tumor-growth inhibition and tumor-selective pharmacodynamics in mouse models of cancer.
    Jenkins KA, Park M, Pederzoli-Ribeil M, Eskiocak U, et al · · 2023 · cited 13× · PMID 38164757 · DOI 10.1136/jitc-2023-007785
  5. Emerging therapeutic strategies for enhancing sensitivity and countering resistance to programmed cell death protein 1 or programmed death-ligand 1 inhibitors in non-small cell lung cancer.
    Villaruz LC, Blumenschein GR, Otterson GA, Leal TA. · · 2023 · cited 10× · PMID 36848319 · DOI 10.1002/cncr.34683
  6. New frontiers in prostate cancer treatment from systemic therapy to targeted therapy.
    Nouruzi S, Kobelev M, Tabrizian N, Gleave M, et al · · 2025 · cited 3× · PMID 40759791 · DOI 10.1038/s44321-025-00282-8
  7. Emerging Therapeutic Approaches to Pancreatic Adenocarcinoma: Advances and Future Directions.
    Peng C, Oberstein PE. · · 2025 · cited 1× · PMID 40884689 · DOI 10.1007/s11864-025-01352-2
  8. Combination immunotherapy for colorectal cancer: Clinical applications, rationale, challenges, and future perspectives.
    Fei J, Cai C, Wu W, Shen H, et al · · 2026 · PMID 41950929 · DOI 10.1016/j.xcrm.2026.102728

Verify or expand the search:

Other recruiting trials for Advanced Solid Tumor

Currently open trials in the same condition.

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Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04896697.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing