THEORY

Does NCT05652894 meet its primary endpoint at primary completion?

HX008(Pucotenlimab) · Metastatic Colorectal Cancer · Phase 3

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Trial

NCT
NCT05652894
Drug / intervention
HX008(Pucotenlimab)
Indication
Metastatic Colorectal Cancer
Phase
3
Sponsor
Taizhou Hanzhong biomedical co. LTD
Primary completion
2026-06-30
Status
open

Theories (1)

85% likely to meet · workos:user_01KSZTKKXBYCCV0QQHTN6WP9S8

target PD-1 · moa checkpoint-inhibition · failure mode none

  1. premise MSI-H/dMMR colorectal tumors carry an exceptionally high neoantigen load, making them the canonical checkpoint-responsive colorectal subset where T-cell recognition is the rate-limiting step that PD-1 blockade relieves
  2. premise In the identical 1L MSI-H/dMMR mCRC setting, pembrolizumab monotherapy roughly doubled progression-free survival versus chemotherapy in KEYNOTE-177 (median ~16.5 vs ~8.2 months, HR ~0.60) nct:NCT02563002 pmid:33264544
  3. premise The same class benefit was independently reproduced with nivolumab with or without ipilimumab versus chemotherapy in 1L MSI-H/dMMR mCRC in CheckMate-8HW
  4. inference Pucotenlimab is another anti-PD-1 tested in the same biomarker-locked 1L population against a chemotherapy comparator, so it engages the exact rate-limiting step already shown twice to be unlockable by the class; this is mechanism replication, not a new bet
  5. prediction PFS by IRC is met in the intended direction with HR below 0.7

Evidence: nct:NCT02563002, pmid:33264544

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