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NCT05228119
A Study of Oncolytic Virus Injection (RT-01) in Combination With PD-1 Inhibitor in Patients With Advanced Solid Tumors
Phase 1 trial testing Oncolytic Virus Injection(RT-01) in Advanced Solid Tumor in 50 participants. Status unknown.
1 October 2022
Quick facts
| Lead sponsor | The Affiliated Hospital of Xuzhou Medical University |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 4 January 2022 |
| Primary completion | 1 October 2022 |
| Estimated completion | 1 October 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Oncolytic Virus Injection(RT-01)
Conditions studied
- Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
Sponsor
The Affiliated Hospital of Xuzhou Medical University
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 single-arm, open-label, exploratory study to evaluate safety and efficacy of oncolytic virus injection(RT-01) in combination with PD-1 inhibitor (Nivolumab) in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The immunoreactivity, The immunogenicity, pharmacokinetics and virus shedding of RT-01 in combination with PD-1 inhibitor.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Biomaterial-Based In Situ Cancer Vaccines.
Bo Y, Wang H. · · 2024 · cited 55× · PMID 36649567 · DOI 10.1002/adma.202210452 -
Oncolytic virotherapy in cancer treatment: challenges and optimization prospects.
Chen L, Zuo M, Zhou Q, Wang Y. · · 2023 · cited 54× · PMID 38169820 · DOI 10.3389/fimmu.2023.1308890 -
Comprehensive assessment on the applications of oncolytic viruses for cancer immunotherapy.
Omole RK, Oluwatola O, Akere MT, Eniafe J, et al · · 2022 · cited 15× · PMID 36569326 · DOI 10.3389/fphar.2022.1082797 -
Recent advances in oncolytic virus combined immunotherapy in tumor treatment.
Zhou X, Hu S, Wang X. · · 2025 · cited 4× · PMID 40821119 · DOI 10.1016/j.gendis.2025.101599 -
Resistance to oncolytic virotherapy: Multidimensional mechanisms and therapeutic breakthroughs (Review).
Xu J, Xia Z, Wang S, Xia Q. · · 2025 · cited 3× · PMID 40849827 · DOI 10.3892/ijmm.2025.5612 -
Precision oncolytic viral therapy in colorectal cancer: Genetic targeting and immune modulation for personalized treatment (Review).
Sultan MH, Zhan Q, Wang Y, Xia Y, et al · · 2025 · cited 3× · PMID 40342021 · DOI 10.3892/ijmm.2025.5545 -
A Comprehensive Review of Modern Cancer Therapies Utilizing Oncolytic Viruses.
Sułek M, Szuster-Ciesielska A. · · 2025 · cited 1× · PMID 41294877 · DOI 10.3390/cells14221825 -
Enhancing antitumor immunity through oncolytic viruses: advances in genetic engineering.
Zubair A, Lazarou L, Alkahtani AM, Shahani MY, et al · · 2026 · PMID 41811580 · DOI 10.1007/s12672-026-04792-w
Verify or expand the search:
- PubMed search for NCT05228119
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Oncolytic Virus Injection(RT-01)
Trials testing the same drug.
- NCT05136937 — A Clinical Study of Intratumoral Administration of RT-01 in Patients With Advanced Solid Tumors · Phase 1 · unknown
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 The Affiliated Hospital of Xuzhou Medical University trials
Trials by the same sponsor.
- NCT06683131 — Effectiveness of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor Initiation Before Percutaneous Coronary · Phase 4 · not yet recruiting
- NCT07295366 — Early Administration of PCSK9 Inhibitors After Thrombectomy for Atherosclerotic Acute Ischemic Stroke: A Randomized Cont · Phase 4 · recruiting
- NCT07285395 — AT1019 Plus SBRT and PD-1 Inhibitor for Advanced Solid Tumors: An IIT Study · Phase 1 · recruiting
- NCT07301372 — Evaluation Study of Early Administration of Evolocumab After Thrombolysis in Patients With Atherosclerotic Acute Ischemi · Phase 4 · recruiting
- NCT07133776 — Application of PD-1 Inhibitors Combined With Tenofovir, Chidamide and Lenalidomide in the Treatment of EBV-associated Di · Phase 1, PHASE2 · not yet recruiting
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 NCT05228119 (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 The Affiliated Hospital of Xuzhou Medical University
- Last refreshed: 9 May 2022
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/NCT05228119.
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