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.
Sequential
T3011
Biological/VaccineT3011 will be administered up to 4mL as an intratumoral injection given Q2W.
T3011 + pembrolizumab
Combination productT3011 will be administered up to 4mL as an intratumoral injection in combination with intravenous pembrolizumab given Q3W.
Safety and tolerability of escalating doses T3011
Number of participants in dose escalating cohorts with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
To determine the dose(s) of T3011 to be examined in Phase 2a
Incidence of DLTs
Safety and tolerability of T3011 dose(s) selected from Phase 1 in disease specific cohorts
Number of participants with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
Characterize the safety and tolerability of T3011 in combination with pembrolizumab
Number of participants with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
Overall response rate (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to intervention, based on assessments by RECIST v1.1 and iRECIST.
Disease control rate (DCR)
DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments by RECIST v1.1 and iRECIST.
Duration of response (DOR)
DOR is defined as the time from the first met CR or PR until disease progression or death due to any cause, whichever occurs first.
Durable response (DR)
DR is defined as objective response (CR or PR) according to RECIST v1.1 and iRECIST.
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