CompletedPhase 1

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

United States28 participantsStarted 2023-06-20

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Maximum Tolerated Dose

Timeframe: 12 months

Trial details

NCT IDNCT05826275

SponsorToragen, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-28

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