Primary Outcome Measures :Frequency and severity of Adverse...

Primary Outcome Measures :

1. Frequency and severity of Adverse Events of IV and IT CF33-hNIS as a monotherapy or in combination with pembrolizumab [ Time Frame: From first dose of study drug through 30 days following the last dose of study treatment. ]
   Adverse events will be graded according to CTCAE v5.0.
2. Recommended Phase 2 Dose (RP2D) of CF33-hNIS as a monotherapy or in combination with pembrolizumab [ Time Frame: From first dose of study drug through 21-42 days following the first dose of study treatment. ]
   RP2D determination will be based on evaluation of Dose Limiting Toxicities (DLT) as well as other safety, efficacy and correlative data.

They need to achieve this to tick off the Primary Completion date, which I think they will comfortably do by December 2024.

I'm expect they will enrol minimum numbers in each cohort until they identify OBD/RP2D, after which they will enrol as many patients as they can up to the estimated 100. Bearing in mind if they run 5 cohorts in the monotherapy and 4 in the combination, that will account for 54 patients plus up to 20 in the Biliary Tract Cancer expansion brings it up to 74. There will only be 26 spots left within that 100.

I would not be surprised to see the study completion date moved back (like has happened in the 1st HER-Vaxx Ph2) to obtain additional data for the secondary outcome measures.