A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOutpace Bio, Inc.
About this trial
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. Participants will be in the hospital when they receive OPB-101 and then be checked at the clinical site frequently for the first few months.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- OPB-101
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov