It's looking like March to me for MTD. The end ultimately needs to have the 6 patients on a cycle. First, you have to have a level where 2 of 3, or 2 of 6 patients have a DLT. Then the Final Cycle is no more than 1 of 6 has a DLT.
Given the low number of patients and the confirmation they are at 560, I would bet they have 3 at 560 now and are waiting to see if 2 have a DLT. That may take another 1 or 2 weeks. If no DLT, up to next level. If 2 DLTs, move down and you need the full 6 patient level. So recruit 3 more and do a 3 week cycle. Either case puts it to March.
I don't think they are at a 6 patient level yet or we'd hear there's a bunch of spots available. They seem to be hard to get; hence, my conclusion they are at the 3 patient 560 level. From the comment they think they're close, maybe they saw 1 DLT already at 560 but that's just a guess. You'd need 2 to stop and move down for the final 6 patient test.
In either case, they need to finish this cycle with 3 patients and at least one more full cycle. The reason is we know they went UP to 560 last week, not back down to 420. So for 420 it would finish up in 6 weeks (assumes 3 weeks to get the extra 3 patients). Any further level, add 3-4 more weeks. This would only be wrong if they are running the full 6 patients now and moving them all up and down, which would take 3 weeks of recruiting out of the above.
I really hope they have added more sites and activated all they currently have. It does not show anything on Clinicaltrials site. Get moving with more sites for 1b! 5 recruiting sites, 2 who are very small, is not enough to quickly get 40 patients in 4 tumors. C'mon guys, please, ramp it.
From Clinicaltrials.gov:
- Maximum tolerated dose (MTD) of TH1902. [ Time Frame: Up to 21 days ]
The MTD will be defined as the dose level at which no more than one of six patients experiences a dose limiting toxicity (DLT) after 21 days of treatment have occurred, with the next higher dose having at least 2 of 3 or 2 of 6 patients experiencing a DLT.
- Recommended Phase 2 Dose (RP2D) of TH1902. [ Time Frame: Up to 24 months ]
The RP2D will be determined following the determination of the MTD and an overall assessment of safety as determined by the Safety Committee.
- Maximum tolerated dose (MTD) of TH1902. [ Time Frame: Up to 21 days ]
The MTD will be defined as the dose level at which no more than one of six patients experiences a dose limiting toxicity (DLT) after 21 days of treatment have occurred, with the next higher dose having at least 2 of 3 or 2 of 6 patients experiencing a DLT.
- Recommended Phase 2 Dose (RP2D) of TH1902. [ Time Frame: Up to 24 months ]
The RP2D will be determined following the determination of the MTD and an overall assessment of safety as determined by the Safety Committee.