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Tests treatment safety and results for Ovarian Cancer Recurrent
Official title A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer
ClinicalTrials.gov ID: NCT07030907
What this study is testing
What is OPB-101?
OPB-101 is an investigational medicine, being studied as a potential treatment for ovarian cancer recurrent.
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
- The goal of this clinical trial is to learn if OPB-101 is safe in platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-101. Participants will have their own T cells modified in a laboratory and given back to them as OPB-101 in this one-time treatment.
- 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 18 and older, women only
You may be able to join if
- Age ≥ 18 years of age at the time of signing the informed consent form.
- Histologically confirmed diagnosis of high grade serous epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological...
- Recurrent platinum-resistant disease defined as: Disease that has recurred within 6 months of the last receipt of platinum-based therapy.
- Received at least 2 prior lines of systemic chemotherapy including a platinum-based chemotherapy.
- Received prior therapy with a PARP inhibitor if the subject has a known germline or somatic BRCA1/2 mutation.
You likely can't join if
- Women of child-bearing potential who are pregnant or breastfeeding.
- Uncontrolled bacterial, fungal, or viral infections.
- Active infection requiring systemic therapy.
- Bleeding or thrombotic disorders or at risk for severe hemorrhage.
- Any form of primary immunodeficiency.
- Had an allogenic tissue/solid organ transplant.
See the full eligibility criteria
- Age ≥ 18 years of age at the time of signing the informed consent form.
- Histologically confirmed diagnosis of high grade serous epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological findings.
- Recurrent platinum-resistant disease defined as: Disease that has recurred within 6 months of the last receipt of platinum-based therapy.
- Received at least 2 prior lines of systemic chemotherapy including a platinum-based chemotherapy.
- Received prior therapy with a PARP inhibitor if the subject has a known germline or somatic BRCA1/2 mutation.
- Measurable disease.
- Consent to provide archived tumor tissue sample.
- ECOG performance status of 0 or 1.
- Adequate organ function.
- Alkaline phosphatase ≤ 2.5 x ULN
- ≤ Grade 1 dyspnea and oxygen saturation levels (SpO2) \> 92% on room air.
- LVEF ≥ 50%
- Life expectancy of ≥ 3 months
- Adequate venous access.
- Negative screen for infectious disease markers.
- Negative serum pregnancy test.
- Abstain from heterosexual activity or to use 2 forms of effective methods of contraception. Note: Other protocol defined could apply
- Women of child-bearing potential who are pregnant or breastfeeding.
- Uncontrolled bacterial, fungal, or viral infections.
- Active infection requiring systemic therapy.
- Bleeding or thrombotic disorders or at risk for severe hemorrhage.
- Any form of primary immunodeficiency.
- Had an allogenic tissue/solid organ transplant.
- Active autoimmune disease.
- Concurrent treatment with systemic high dose corticosteroids.
- Unresolved acute effects of any prior therapy.
- Active invasive cancer other than the cancer under study.
- Significant lung disease.
- Clinically significant pericardial effusion.
- Prior radiotherapy within 2 weeks of start of study intervention.
- No major surgery within 28 days prior to enrollment.
- Received investigational agents or tumor vaccines.
- Received chemotherapy within the previous 3 weeks.
- History of grade ≥ 3 ascites.
- Active CNS involvement.
- Received a live vaccine within 30 days prior to study treatment.
- Received prior CAR T cell therapy.
- Received prior mesothelin targeted therapy.
- Dependent on intravenous hydration or total parenteral nutrition. Note: Other protocol defined exclusion criteria could apply
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Buffalo, New York, United States
- Houston, Texas, United States
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States; Minneapolis, Minnesota, United States; Buffalo, New York, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.