Actively Recruiting
ETC-159 In Combination With Pembrolizumab In Advanced MSS/pMMR Ovarian Cancers
Led by National University Hospital, Singapore · Updated on 2025-07-25
16
Participants Needed
2
Research Sites
133 weeks
Total Duration
On this page
Sponsors
N
National University Hospital, Singapore
Lead Sponsor
E
EDDC (Experimental Drug Development Centre), A*STAR Research Entities
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label, single-arm, investigator-initiated study conceived as a dose expansion cohort of the study D3-002, which evaluated ETC-159 in combination with pembrolizumab in solid tumors.
CONDITIONS
Official Title
ETC-159 In Combination With Pembrolizumab In Advanced MSS/pMMR Ovarian Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent and comply with study requirements
- Female aged 21 years or older
- Histologically or cytologically confirmed advanced or metastatic ovarian cancer with platinum resistance (platinum free interval less than 6 months or no longer an option)
- MSS/pMMR tumors confirmed by IHC, PCR, or NGS
- Radiologically and clinically confirmed disease progression at screening
- Measurable disease per RECIST v1.1 criteria
- ECOG performance status 0 to 2 at screening
- Life expectancy of at least 3 months
- Adequate organ function including specified blood counts, coagulation parameters, liver enzymes, kidney function, calcium and magnesium levels
- T-score greater than -1; patients with osteopenia eligible with supplementation, osteoporosis patients excluded
- Able to swallow study medication or have a daily caregiver for administration
- Negative pregnancy test for females of childbearing potential
- Mandatory pre-dose and post-dose tumor biopsies unless unsafe or inaccessible
You will not qualify if you...
- Received anti-cancer therapy, including immunotherapy, within 4 weeks prior to study start or unresolved side effects
- Used other investigational drugs within 4 weeks or five half-lives prior to first dose
- Other malignancies not in remission or within last 3 years (except certain skin or cervical cancers)
- Central nervous system metastases unless treated and stable without steroids
- Recent radiation therapy within specified timeframes or unresolved side effects
- History of certain lung diseases or pneumonitis
- Received bisphosphonates or denosumab for osteoporosis within 6 months
- Osteoporosis or history of fragility fractures or severe vertebral fractures
- Elevated beta-CTX serum levels at screening
- Low thyrotropin or vitamin D levels unless corrected
- Presence of bone metastases or metabolic bone diseases
- Unable to start bone protective treatment as required
- Prolonged glucocorticoid use at high doses within 12 weeks
- Active autoimmune disease needing systemic treatment in past 2 years
- Females of childbearing potential not using effective contraception or pregnant/nursing
- Recent major surgery or unresolved complications
- History of long QT syndrome or significant coagulopathy
- Recent use of certain anticoagulants except specified exceptions
- Severe or unstable medical conditions
- Known HIV, active hepatitis B or C, or other active infections
- History of gastric bypass surgery
- Serious non-healing wounds or vasculitis
- Prior treatment with Wnt-beta-catenin pathway inhibitors or Wnt-immunotherapy combinations
- Unable or unwilling to comply with protocol
- Inability to provide tumor tissue unless approved
- Recent use of hematopoietic colony stimulating factors
- Recent active infections requiring systemic antimicrobial treatment
- Recent live vaccine administration except specified exceptions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
National Cancer Centre Singapore
Singapore, Singapore, Singapore, Singapore 169610
Not Yet Recruiting
2
National University Hospital
Singapore, Singapore
Actively Recruiting
Research Team
S
Shao peng David Tan
CONTACT
T
Tan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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