RE:RE:RE:RE:ASCO June 2023 I agree with paragraph 1 and 2 100%. I think you are right about 1a and 1b being separate entities.
"I'm encouraged they actually put it all together and wrote it up."
I think there is something close to an obligation to do this whether successful or not given the participation of human subjects. So it's not so surprising they are putting out a poster. At best maybe it'll be seen as a positive if they really can string together a convincing narrative on restarting the 1b program before the poster gets presented. At worst it's just an obligation they have as part of their clinical trial commitments. The importance of this is really dependant on what happens around it with the restart.
Wino115 wrote: The sciene guys can chime in, but I think from a pure research standpoint, clinical investigators look at each part of a trial as a very separate experiement with it's own questions, data and answers. You pay the CRO to tabulate all that data, report it out and then you base your conclusions and hypothesis around that data. The first part was fully self-contained and they got all that data so you can actually conclude something and write it up. I'm sure the oncology committee saw all that plus all the rest. But you can't really write up an experiment until it's finished and just talking about some additional data that pretty clearly wasn't cutting it, but also wasn't even complete, isn't what any investigator would do.
I doubt you'll even see 1b referenced as there's not a whole lot you can say except that you used the conclusions from your paper to proceed with the next step. The next paper, if they get there, will be what that initial set showed, what informed them to change it going forward, and did it do anything as far as the main issue of efficacy with similar safety.
I'm encouraged they actually put it all together and wrote it up. It should have a lot of the PK/PD data in it I would hope and probably some conclusions that we've maybe not heard before. Hard to tell as it could just be as simple as here's the way we did it, it was safe up to this level, we backed down, we finished it up and saw some preliminary signs of efficay and moved to part 1b. That may be it, in which case we already know all that. She's pretty clearly a leading investigator on genetically targeted therapies, ADCs and PDCs, so hopefully she has some insights to share and can give a bit more insight than just repeating what happened. But, alas, it's just a poster with a few charts and paragraphs.