RE:RE:Cancer phase 1 expectations It will be interesting to see if the dosage study portion ultimately winds up at a much larger equivalent dosage of what they can do in plain docetaxel. That's what some of their previous studies showed. I believe someone calculated it could be up to 20x more on an equivalent basis. So you can prove you are getting more of the chemo right into the tumor, and if SAEs are low, we'd have safety with much larger doses. That alone is a great outcome to start with.
Efficacy in this part, I think, would mostly be related to overall response rates (probably hard to have complete responses and more likely just partial responses) and survival length. Each tumor is different, but from what I can see in a lot of trials, good response rates are 35% or higher and adding 6 months or more is pretty good. Both of those are huge generalizations and very cancer dependent. Like you say, these are probably metasticizing cases and tumor shrinkage could be hard to come by at this stage when you're not fully at effective dosage and may not have the length of time needed for some. I'm with you though, we can't expect a miracle, but there may be some validation of the many effects seen in the pre-clinical which would be a great start.
juniper88 wrote: Yes, phase I is about safety. But if TH-1902 doesn't show efficacy in this population it won't show efficacy in a less treated population. Sortilin expression increases as the disease progresses. This is how TH-1902 is very different from other treatments.
jeffm34 wrote: I think we have to temper expectations of efficacy in the phase 1 trial. They are enrolling patients with no other options left so their prognosis is very poor. Success in this trial will be if TH1902 is no more toxic than docetaxel alone. If there are no significant signs of efficacy, it is not necessarily a failure. If there is significant efficacy in this patient population it would be pretty amazing to say the least.
The phase 1 study will comprise dose-escalation and dose-expansion portions.7 Patients have to have recurrent advanced solid tumors, have relapsed on or be refractory to standard chemotherapy, surgery, and radiation, and have no effective alternative treatment options to be eligible for the first-in-human study of TH1902.