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New treatment option for With MSS/pMMR Advanced, Platinum-resistant Ovarian Cancer
Official title ETC-159 In Combination With Pembrolizumab In Advanced MSS/pMMR Ovarian Cancers
ClinicalTrials.gov ID: NCT06513624
What this study is testing
What is ETC-159?
ETC-159 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for with mss/pmmr advanced, platinum-resistant ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 99, women only
You may be able to join if
- Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with the...
- Is female, and age 21 years or older (Singapore sites) at pre-screening or screening.
- Has histologically or cytologically confirmed, advanced or metastatic ovarian cancer with a platinum free interval of less than 6 months from prior...
- Has MSS/pMMR tumors as determined by immunohistochemistry (IHC), polymerase chain reaction (PCR), or next-generation sequencing (NGS).
- Has objective (assessable through clinical signs, symptoms, and/or laboratory findings) and radiologically-confirmed progression of disease at...
You likely can't join if
- people should not enter the study if any of the following exclusion criteria are fulfilled: Patients meeting any of the following criteria will be...
- Has received anti-cancer therapy including immunotherapy within 4 weeks (28 days) prior to starting study drug or the side effects of such therapy...
- Has used other investigational drugs within 4 weeks (28 days) or five half-lives (whichever is longer) prior to the first dose of study drug.
- Has evidence of another malignancy not in remission or history of such a malignancy within the last 3 years (except for treated basal or squamous...
- Has central nervous system metastases, unless previously treated with surgery, whole-brain radiation or stereotactic radiosurgery, and stable disease...
- Has received prior radiation therapy within 4 weeks (28 days), or limited field radiation within 2 weeks, prior to starting study drug, or the side...
See the full eligibility criteria
Who can join
- Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with the protocol requirements.
- Is female, and age 21 years or older (Singapore sites) at pre-screening or screening.
- Has histologically or cytologically confirmed, advanced or metastatic ovarian cancer with a platinum free interval of less than 6 months from prior platinum based treatment or for whom platinum therapy is no longer an...
- Has MSS/pMMR tumors as determined by immunohistochemistry (IHC), polymerase chain reaction (PCR), or next-generation sequencing (NGS).
- Has objective (assessable through clinical signs, symptoms, and/or laboratory findings) and radiologically-confirmed progression of disease at Screening.
- Has measurable disease as determined by RECIST v1.1 (Appendix 4, Section 12.4). Target lesions should not be selected in previously irradiated fields unless there is clear evidence of progression.
- Has ECOG performance of status 0 to 2 at Screening.
- Has life expectancy of at least 3 months at Screening.
- Has adequate organ function at Screening, including the following (noting that repeated tests Screening should not be performed unless there are sufficient reasons to assume the patient would meet the with re-testing).
- Absolute neutrophil count ≥1.0 × 109/L
- Platelet count ≥100 × 109/L (without transfusions within 21 days prior to Day 1 of Cycle 1
- Hemoglobin ≥9 g/dL
- Prothrombin time and partial thromboplastin time within ≤1.5 × upper limit of normal (ULN)
- International normalized ratio (INR) ≤1.5 × ULN Note: If the patient is on allowed anti-coagulants the INR and coagulation parameters should be in the therapeutic range
- Total bilirubin ≤1.5 × ULN
- Transaminases (AST and/or alanine aminotransferase ≤2.5 × ULN (\<5 × ULN if liver metastases)
- Calculated creatinine clearance ≥40 mL/min (Cockroft and Gault formula)
- Total calcium (corrected for serum albumin) within normal limits prior to Day 1 of Cycle 1 (supplementation is permitted). Note: Patients with grade 1 changes can be included as long as they are asymptomatic and can...
- Patients must have a T-score greater than -1 to be eligible, however, patients with osteopenia (defined as a T-score of -1 to -2.5 at the left or right total hip, left or right femoral neck, or lumbar spine [L1 to L4]...
- Is capable of swallowing study medication and following directions regarding taking study drug or has a daily caregiver who will be responsible for administering study drug.
- Has a negative serum pregnancy test at Screening or a negative urine pregnancy test within 7 days prior to Day 1 Cycle 1 prior of treatment (applies to females of childbearing potential only).
- For all patients: pre-dose and post-dose tumor biopsies are mandatory unless tumor is inaccessible or deemed unsafe for procedure by the principal investigator. Note: NGS reports can be collected where biopsies are not...
What rules you out
- people should not enter the study if any of the following exclusion criteria are fulfilled: Patients meeting any of the following criteria will be excluded from the study (note that exclusion criteria must be assessed...
- Has received anti-cancer therapy including immunotherapy within 4 weeks (28 days) prior to starting study drug or the side effects of such therapy have not resolved to Grade ≤1 within 4 weeks prior to starting study...
- Has used other investigational drugs within 4 weeks (28 days) or five half-lives (whichever is longer) prior to the first dose of study drug.
- Has evidence of another malignancy not in remission or history of such a malignancy within the last 3 years (except for treated basal or squamous cell carcinoma of the skin, or in situ cancer of the cervix).
- Has central nervous system metastases, unless previously treated with surgery, whole-brain radiation or stereotactic radiosurgery, and stable disease for at least 8 weeks without steroid use for at least 4 weeks (28...
- Has received prior radiation therapy within 4 weeks (28 days), or limited field radiation within 2 weeks, prior to starting study drug, or the side effects of such therapy have not resolved to Grade ≤1.
- Has any history of direct radiation to spine or pelvis bone or definitive chemoradiation to pelvic organs in the last 6 months prior to starting study drug, or the side effects of such therapy have not resolved to Grade...
- Has a history of interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or pulmonary hypersensitivity, or pneumonitis.
- Has received bisphosphonate therapy for osteoporosis or symptomatic hypercalcemia or denosumab for osteoporosis within 6 months prior to starting study drug.
- Has osteoporosis based on a T-score of \< -2.5 at the left or right total hip, left or right femoral neck, or lumbar spine (L1 to L4) as determined by DEXA scan at Screening (for details of calculating T-score for...
- Has a history of symptomatic vertebral fragility fractures or any fragility fracture of the hip, pelvis, wrist, or other location (a fragility fracture is defined as any fracture without a history of trauma or as a...
- Has moderate (25% to 40% decrease in the height of any vertebra) or severe (\>40% decrease in the height of any vertebra) morphometric vertebral fractures at Screening.
- Has a β-CTX serum level \>1000 pg/mL in the morning after at least 10 hours of fasting at Screening. Note: Patients should begin their treatment with the bone protective treatment (denosumab with a starting dose of 120...
- Has thyrotropin level less than LLN at Screening
- Has 25-hydroxy vitamin D levels less than 25 nmol/L (10 ng/mL) at screening. Note: For patients known to have less than 25 nmol/L (10 ng/mL) 25-hydroxy vitamin D value that would otherwise be eligible to participate in...
- Has bone metastases at Screening.
- Has a metabolic bone disease, such as hyperparathyroidism, Paget's disease, or osteomalacia.
- Cannot start treatment with the bone protective treatment with denosumab and/or zoledronic acid. Cannot start treatment with the bone protective treatment with denosumab SC, in patients requiring this treatment at the...
- Is receiving active treatment with an oral or IV glucocorticoid for ≥4 weeks (≥28 days) at a daily dose equivalent to ≥10 mg of oral prednisone within the 12 weeks prior to starting the ETC-159.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine...
- Is a female patient of childbearing potential, defined as a female physiologically capable of becoming pregnant (including a female whose career, lifestyle, or sexual orientation precludes intercourse with a male...
- Total abstinence: This is an acceptable method when this is consistent with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and...
- Female sterilization: The patient has had a surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks prior to taking study drug. In case of an oophorectomy alone, the...
- Male partner sterilization: The patient has the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate. (For female patients on the study, the vasectomized male partner should be the sole...
- Use of a combination of the following (1+2):
- Placement of an intrauterine device or intrauterine system
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, gel, film, or cream, or vaginal suppository
- Reliable contraception maintained throughout the study and for 12 weeks after study drug discontinuation
- Females considered post-menopausal and not of childbearing potential: The definition applies to females who have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age...
- Is a pregnant or nursing (lactating) female, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory...
- Has had a major surgical procedure within 4 weeks (28 days) from starting the study drug. Patient has not fully recovered from all surgery-related complications to Grade ≤1.
- Has a history of long QT syndrome or prolonged QT interval corrected (QTc) (\>460 ms) at Screening. Both Bazett's and Fridericia's QTc are accepted and should be used consistently through the study (either Bazett's or...
- Has a known clinically significant bleeding disorder or coagulopathy.
- Is receiving or has received within 4 weeks prior to starting study drug, heparin, warfarin, or other similar anti-coagulants, except for patients on low molecular weight heparin or Direct-Acting Oral Anticoagulants...
- Has severe or unstable medical conditions such as heart failure, ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, an ongoing cardiac arrhythmia requiring...
- Has a known history of human immunodeficiency virus, or active infection with hepatitis B (unless DNA count \< 500) or hepatitis C virus or other active bacterial, viral, or fungal infections.
- Has a history of gastric bypass surgery.
- Has a serious non-healing wound, or vasculitis.
- Has received prior treatment with an inhibitor of the Wnt-β-catenin pathway other than the study drug in question or received wnt-immunotherapy combinations.
- Is unwilling to or unable to comply with the protocol.
- Patient is unable to provide tumor tissue unless approved by the lead- sponsor investigator
- Has received prophylactic administration of hematopoietic colony stimulating factors (colony stimulating factors, e.g., granulocyte colony stimulating factor, granulocyte/macrophage colony stimulating factor...
- Has recent or current active infectious disease requiring systemic antibiotics or antifungal or antiviral treatment within 2 weeks (14 days) prior to the start of study drug. Patients receiving prophylactic antibiotics...
- Has received a live vaccine within 28 days prior to the start of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow...
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore, Singapore
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 21 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore, Singapore; Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.