A Phase 1 Study to Evaluate the Safety and Efficacy of OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.

Trial statusNot yet recruiting
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-201 is safe in recurrent endometrial and platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-201. Participants will have their own T cells modified in a laboratory and given back to them as OPB-201 in this one-time treatment. Participants will be in the hospital when they receive OPB-201 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 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.

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-201

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators