Endometrial Cancer Recurrent study: OPB-201
Official title A Study to Evaluate OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
ClinicalTrials.gov ID: NCT07664735
What this study is testing
What is OPB-201?
OPB-201 is an investigational cell therapy being studied as a potential treatment for recurrent endometrial cancer. It is designed to use your own T cells, which are modified in a lab to better recognize and target cancer cells, and then given back to you.
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 study is testing whether OPB‑201 is safe and how much of it works best for people with recurrent endometrial or platinum‑resistant ovarian cancer.
- Who it's for
- You may be able to join if you have recurrent endometrial cancer or platinum‑resistant ovarian cancer and meet the study’s health criteria.
- What's involved
- You will have your own T cells taken, changed in a lab, and then given back to you as OPB‑201 in a single hospital visit. Afterward, you will have regular check‑ins at the clinic for the first few months.
- Time commitment
- The study lasts a few months, with one hospital visit for the treatment and several follow‑up visits at the clinic.
- 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 endometrial cancer, epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological...
- Received at least 1 prior line 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.
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 endometrial cancer, epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological findings.
- Received at least 1 prior line 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.
- HLA-A \ 02:01 or HLA-A \ 02:02
- PRAME positive tumor
- 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.
- Other exclusions as stated in the protocol.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
- Atlanta, Georgia, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, 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, but 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?
This study is enrolling now at San Francisco, California, United States; Atlanta, Georgia, United States; Detroit, Michigan, United States; Minneapolis, Minnesota, United States; Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.