Clinical Trial

Title: GYN 174 25189
A Randomized, Open-label, Multicenter, Phase 3 Study To Investigate Mocertatug Rezetecan Compared With Chemotherapy In Participants With Endometrial Cancer After Platinum-based Chemotherapy And Immunotherapy (BEHOLD-Endometrial01)

MOA: Mocertatug rezetecan (Mo-Rez) is a B7-H4 targeted ADC with a TOPO1 inhibitor (TOPO1i) payload

Key Eligibility:

• Histologically confirmed EC (incl endometrioid, serous, clear cell,
  endometrial carcinosarcoma; mixed epithelial carcinomas are permitted)
• 1-2 prior lines of systemic tx for EC. Up to 3 prior lines allowed if one was
  in (neo)adjuvant setting
  • Adjuvant ± neo-adjuvant tx counts as one line
  • Hormonal tx, maintenance tx or switching to another agent within the
    same class are NOT counted as a separate line of tx
  • Prior tx with any TOPO1i or B7-H4 targeted tx are excluded
• Must have PD on/after prior plt-based chemo AND
  (L)1 tx either separately or in combination
  have received anti-PD
  • Pt deemed unsuitable for prior anti-PD-(L)1 by investigator are eligible
  • If plt-based tx solely in adjuvant setting: PFI <12 months
  • If PD-(L)1 combined with plt-based tx OR underwent tx OR metastatic disease who pt intolerant to plt-based tx: eligible regardless of PFI
• ≥1 target lesion per RECIST v1.1 by BICR
• Central assessment
  of B7-H4 expression required prior to randomization