ENDOMETRIAL: PHASE-1 (EXPANSION): RECURRENT: LEAP-ENDOMETRIAL

A Phase 2 Study Evaluating the Efficacy and Safety of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial or Epithelial Ovarian Cancer

Title
LEAP DEK-DKK1-204 (Endometrial)
Study Title

A Phase 2 Study Evaluating the Efficacy and Safety of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial or Epithelial Ovarian Cancer

Site Link
Malignancy
Endometrial Cancer, Uterus Cancer
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
2nd or later
Investigational Agent
DKN-01
Drug Class
DKK1 monoclonal antibody
PI
Adam ElNaggar, MD
Sponsor
Leap Therapeutics
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically confirmed recurrent epithelial endometrial cancer
    • Patients with germ cell, sex cord stroma, carcinosarcoma, or sarcoma are only eligible if tumor has mixed endometrioid component with documented Wnt signaling alteration
  • Refractory or intolerant to at least one prior standard therapy for metastatic or locally advanced disease
    • Prior chemoradiation is considered a line of therapy
  • Willing to undergo mandatory pre-treatment and on-treatment biopsies
  • ECOG PS 0-1
  • No recent prior malignanciy
  • No symptomatic CNS metastasis
  • No osteoblastic bone mets
Objective
  • Primary- ORR
  • Secondary
    • DCR
    • OS
    • PFS
    • Safety
    • TTP, DoR, DoCR, TTF
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Epithelial endometrial cancer
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X