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NCT07081984
Study of TI-0093 Injection With Recurrent/Metastatic HPV-16 Positive Solid Tumors
Phase 1 trial testing therapeutic tumor vaccine in HPV 16+ Recurrent or Metastatic Cancer in 12 participants. Currently enrolling.
20 September 2026
Quick facts
| Lead sponsor | Therorna |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 11 November 2025 |
| Primary completion | 20 September 2026 |
| Estimated completion | 31 July 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- therapeutic tumor vaccine — full drug profile →
Conditions studied
- HPV 16+ Recurrent or Metastatic Cancer — all drugs for HPV 16+ Recurrent or Metastatic Cancer →
- HNSCC — all drugs for HNSCC →
- Cervical Cancer — all drugs for Cervical Cancer →
Sponsor
Therorna — full company profile →
Who can join
Adults 18 to 75, any sex, with HPV 16+ Recurrent or Metastatic Cancer or HNSCC. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a phase I, open-label, dose escalation study to assess the safety, tolerability, efficacy and immunogenicity of TI-0093 injection in patients with recurrent or metastatic HPV-16 positive solid tumors. The primary objectives of the study are to assess safety and tolerability of TI-0093 injection in patients with recurrent or metastatic solid tumors, and to determine the maximum tolerated doses (MTDs) and recommended Phase 2 doses (RP2Ds) of TI-0093 injection.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Circular RNAs in cancer: Its biogenesis, functions, relationships with cancer progression, applications in immunotherapy and biomarker potentials.
Gao Y, Xu L, Sun R, Gao L, et al · · 2026 · PMID 41915211 · DOI 10.1007/s00262-025-04176-z -
Circular RNA as a New Vaccine Platform: Considerations, Challenges, and Perspectives.
Lee KH, Lee J, Lee SW. · · 2026 · PMID 41893758 · DOI 10.3390/vaccines14030221
Verify or expand the search:
- PubMed search for NCT07081984
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for HPV 16+ Recurrent or Metastatic Cancer
Currently open trials in the same condition.
- NCT04713046 — Safety and Efficacy of Allogeneic HPV-specific T Cells in Adults With Recurrent or Metastatic HPV16+ Cancers · Phase 1, PHASE2 · active not recruiting
Other Therorna trials
Trials by the same sponsor.
- NCT07413341 — A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases · Phase 1 · 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 NCT07081984 (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 Therorna
- Last refreshed: 24 November 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/NCT07081984.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing