Last reviewed · How we verify
NCT04896697
Vilastobart (XTX101) Monotherapy and Vilastobart and Atezolizumab Combination Therapy in Advanced Solid Tumors
Phase 1, PHASE2 trial testing vilastobart (XTX101) in Advanced Solid Tumor in 136 participants. Currently enrolling.
30 March 2026
Quick facts
| Lead sponsor | Xilio Development, Inc. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 136 |
| Start date | 13 September 2021 |
| Primary completion | 30 March 2026 |
| Estimated completion | 30 March 2026 |
| Sites | 19 locations across United States |
Drugs / interventions tested
- vilastobart (XTX101) — full drug profile →
- Atezolizumab (atezolizumab) — full drug profile →
- vilastobart (XTX101) — full drug profile →
Conditions studied
- Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT04896697
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Advanced Solid Tumor
Currently open trials in the same condition.
- NCT07300943 — Study in Advanced Solid Tumor Patients · Phase 1, PHASE2 · recruiting
- NCT07304128 — A Study of PLB-002 in Advanced Solid Tumors · Phase 1 · recruiting
- NCT07213830 — A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity · Phase 1, PHASE2 · recruiting
- NCT07226349 — A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors · Phase 1 · recruiting
- NCT07222267 — An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Soli · Phase 1 · recruiting
Other Xilio Development, Inc. trials
Trials by the same sponsor.
- NCT05052268 — XTX202 in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04896697 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xilio Development, Inc.
- Last refreshed: 29 May 2025
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