West Cancer Center

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

NCT03395080

Malignancy

Endometrial Cancer, Uterus Cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd or later

Investigational Agent

DKN-01

Drug Class

DKK1 monoclonal antibody

Adam ElNaggar, MD

Sponsor

Leap Therapeutics

Phase

Phase 1

Status

Closed to Accrual

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