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NCT02521844

NCT02521844
Active, Not Recruiting Phase 1

Who may be able to join

Who might be able to join this trial:

  • You are at least 18 years old (in the US) or at least 21 years old (in Singapore)
  • You are able to understand and sign a consent form agreeing to take part in the study
  • You have been diagnosed through lab testing with an advanced or metastatic solid tumor cancer that cannot be removed by surgery, and that has not responded to, or you cannot tolerate, available treatments
  • Your disease has been confirmed by scans to be getting worse at the time of screening
  • Your cancer can be measured using standard imaging methods
  • Your general health and ability to do daily activities falls within an acceptable range (confirm with trial site)
  • Your doctors expect you to live for at least 3 more months
  • Your blood counts are at acceptable levels — including white blood cells, platelets, and hemoglobin (red blood cell protein)
  • Your blood clotting tests are within acceptable ranges
  • Your liver function tests are within acceptable ranges
  • Your kidneys are working well enough (filtering at least 60 mL per minute)
  • Your calcium and magnesium levels in the blood are within normal or near-normal ranges (mild abnormalities may be acceptable if you have no symptoms and can take supplements)
  • Your urine test (urinalysis) is normal
  • Your bone density scan result is above a certain threshold — people with mildly low bone density (osteopenia) may still be eligible and will receive calcium and vitamin D supplements; people with osteoporosis are not eligible
  • You are able to swallow the study medication, or you have a caregiver who can give it to you
  • If you are a woman who could become pregnant, you have a negative pregnancy blood test before starting
  • If you have colorectal cancer (including appendix cancer) that is a specific type (called MSS or pMMR), you must have already tried or been unable to tolerate certain standard chemotherapy drugs (confirm with trial site for which drugs apply to you)
  • Depending on which group of the trial you may join, your tumor may need to be tested for specific gene changes (called RSPO2 or RSPO3 fusions), or confirmed to not have these changes (confirm with trial site)
  • If you have ovarian or endometrial cancer of a specific type (MSS or pMMR), further standard chemotherapy is no longer suitable for you
  • If you have another type of solid tumor cancer of a specific type (MSS or pMMR), your doctor has determined that further standard treatment is not suitable, and your tumor has certain molecular features that may make it respond to this trial's treatment (confirm with trial site)
  • You are able to provide a tumor tissue sample (either a fresh biopsy or previously stored tissue) for testing

Who may not be able to join:

  • You are a man who is sexually active with a partner who could become pregnant and you are unwilling to use a condom during the study and for 12 weeks after treatment ends (this also applies to men who have had a vasectomy)
  • You are a woman who could become pregnant and are unwilling to use birth control during the study and for 12 weeks after treatment ends
  • You are currently pregnant or breastfeeding
  • You are currently receiving any other cancer treatment at the same time as this trial
  • You have received another experimental drug within 4 weeks (or within 5 half-lives of that drug, whichever is longer) before starting this trial
  • You have received immunotherapy (such as pembrolizumab) within 4 weeks before starting the study drug (confirm with trial site for specifics based on your cancer type)
  • You have another active cancer, or have had a different cancer within the last 3 years (exceptions may apply for certain minor skin cancers or treated cervical pre-cancer — confirm with trial site)
  • You have cancer that has spread to the brain, unless it was treated and has been stable for at least 8 weeks without the need for steroids for at least 4 weeks before starting the trial
  • You have had radiation therapy within the past 4 weeks (or limited radiation within the past 2 weeks) before starting the trial, or still have side effects from it
  • You have had radiation to your spine or pelvis, or chemotherapy combined with radiation to your pelvic area, in the last 6 months, or the side effects have not mostly resolved
  • You have had a major operation within 4 weeks before starting the study, or you have

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Active, Not Recruiting
Phase
Phase 1
Sponsor
EDDC (Experimental Drug Development Centre), A*STAR Research Entities
Registry
clinicaltrials_gov
Start date
1 October 2015
Est. completion
31 October 2024

Where this trial is recruiting

🇸🇬 Singapore 🇺🇸 United States

Primary endpoints

Maximum Tolerated Dose (MTD) of ETC-1922159 when administered with pembrolizumab (Part B Dose Escalation); Recommended Dose (RD) of ETC-1922159 when administered with pembrolizumab (Part B Dose Escalation); Number of participants with adverse events (AEs) (Part B Dose Expansion); Number of participants with adverse bone density imaging assessments via DEXA scan (Part B Dose Expansion); Number of participants with abnormal 12-lead electrocardiogram (ECG) readings (Part B Dose Expansion); Change in Eastern Cooperative Oncology Group performance status (Part B Dose Expansion); Number of participa...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov