THEORY

Does NCT05231122 meet its primary endpoint at primary completion?

Anti-CD40 Agonist Monoclonal Antibody CDX-1140 · Recurrent ovarian / gynecologic carcinoma · Phase 2

Share on X

Trial

NCT
NCT05231122
Drug / intervention
Anti-CD40 Agonist Monoclonal Antibody CDX-1140
Indication
Recurrent ovarian / gynecologic carcinoma
Phase
2
Sponsor
Roswell Park Cancer Institute
Primary completion
2026-12
Status
open

Theories (1)

67% likely to miss · workos:user_01KSZTKKXBYCCV0QQHTN6WP9S8

target CD40 + PD-1 · moa cd40-agonism + checkpoint-inhibition · failure mode benefit-concentrated-in-unselected-subgroup

  1. premise Many checkpoint non-responders carry a built, stem-like CD8 reservoir stalled at the egress gate in the draining lymph node, awaiting the dendritic-cell licensing signal — the Garrison state. doi:10.5281/zenodo.20479100
  2. premise CD40 agonism supplies exactly that missing licensing signal, so it is the mechanistically correct lever for Garrison-positive patients. doi:10.5281/zenodo.20479100
  3. premise Prior CD40-agonist + checkpoint trials (selicrelumab + atezolizumab; sotigalimab + nivolumab) produced real but mixed signals — the pattern of a benefit averaged across selected and unselected patients.
  4. inference This trial adds agonist anti-CD40 (CDX-1140) to a pembrolizumab + bevacizumab backbone without selecting for the Garrison state, so any benefit is diluted across the non-Garrison majority.
  5. prediction The ORR primary is not met — no clean significant ORR improvement from adding CD40 in the unselected population; the signal, where measured, would concentrate in Garrison-positive patients.

Evidence: doi:10.5281/zenodo.20479100, doi:10.5281/zenodo.19958113

← all trial questions  ·  open data (JSON)  ·  registry ↗