Clinical trial · Interventional
Phase 1 Trial in Patients With Human Papillomavirus (HPV)-Associated Cancer
A Phase 1 Trial of TGN-S11 in Patients With Human Papillomavirus (HPV)-Associated Relapsed, Resistant or Metastatic Cancer
NCT05826275CI-TRIAL-00094823completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, non-randomized, Phase I, dose escalation/dose expansion study in cohorts of patients with relapsed, resistant, or metastatic HPV-associated cancers. The Expansion Phase will begin in parallel one dose level lower than the highest dose deemed safe in the Dose Escalation in combination with a PD-1 checkpoint blockade.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV Associated Cancers | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| TGN-S11 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- To determine the MTD in patients with HPV-associated cancers
- interventionNames
- Drug: TGN-S11
- type
- EXPERIMENTAL
- label
- Dose Expansion
- description
- Dose Expansion Phase, in parallel one dose level lower than the highest dose deemed safe in Dose escalation with a PD-1 checkpoint blockade.
- interventionNames
- Drug: TGN-S11
- Drug: Pembrolizumab
Primary outcomes (1)
- measure
- Maximum Tolerated Dose
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Prior histologically confirmed HPV-associated squamous cell carcinoma, which is relapsed, resistant, or metastatic * Life expectancy of at least 3 months * Dose Escalation Phase: patients who have experienced disease progression on Standard of Care Therapies Exclusion Criteria: * Active CNS metastases * Have any history of seizure disorder or are taking prophylactic seizure medication * Have an active viral, bacterial, or fungal infection
References
Publications (0)
Data not yet available
No reference posted for this study.