This is a Phase 1/2a, open-label, study to evaluate the safety and preliminary efficacy of intratumoral T3011 given alone and in combination with intravenous pembrolizumab in partients with advanced or metastatic solid tumors.
Age 18 years or older.
Disease progression after standard of care (SOC) therapy or in the opinion of
The Investigator unlikely to benefit from SOC therapy. Inclusion Diagnosis Phase 1 - Histologically or pathologically confirmed locally recurrent or metastatic advanced malignancy.
Measurable disease per RECIST version 1.1.
Have only uninjectable tumors..
Patients with injectable tumors impinging upon major airways or blood vessels.
HNSCC only: Prior re-irradiation field containing carotid artery.
Greater than 3 distant metastatic lymph node regions and/or metastatic lesions or the largest distant metastases with a diameter of more than 3 cm (non-sarcoma)/5 cm (sarcoma) unless the lesion is to be injected.