Notes & decisions

Amendment 4 — biomarker schedule update

Add ctDNA collection at week 8 and week 20; remove redundant week 6 draw. IRB submission filed 2026-04-22.

Vendor switch for ctDNA assay

Switching from Vendor X to Vendor Y due to Q2 capacity. Cross-validation requested for 24 split samples.

Enrollment pause — DSMB recommendation

Pause enrollment pending review of two grade-3 hepatic events; no new sites onboarded.

Out-of-window week 16 imaging at Site 09

Three subjects exceeded ±5 day window due to scanner downtime. Documented per SOP-04.

Cohort 3 cleared — expansion to N=12

DLT rate 1/9; safety signals within projection. Expansion approved at SRC.

Site 22 onboarding complete

All credentials verified; first surveillance visits scheduled week of 2026-04-29.

Concomitant med exclusion override (case 044)

Investigator approved short-course corticosteroid for unrelated dermatologic flare; documented per SOP-12.

Amendment 2 — relax ECOG to 0-2

Eligibility relaxed to ECOG 0-2 to widen accrual; safety lead-in reviewed.