Phase 1 Trial in Patients With Human Papillomavirus (HPV)-Associated Cancer

Toragen

Status and phase: Active, not recruiting; Phase 1

Conditions: HPV Associated Cancers

Treatments: Drug: Pembrolizumab; Drug: TGN-S11

Study type: Interventional

Funder types: Industry

Identifiers

NCT05826275

TGN-S11

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Dose Escalation

Experimental group

Description:

To determine the MTD in patients with HPV-associated cancers

Treatment:

Drug: TGN-S11

Dose Expansion

Experimental group

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.

Treatment:

Drug: TGN-S11

Drug: Pembrolizumab