Health TrialsbyHealthPanel

A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer

ConditionsOvarian Cancer RecurrentOvarian CancerPlatinum 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • OPB-101

    Biological/Vaccine

    An autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART designed IL-2 cytokine

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: OPB-101 Treatment ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety

Incidence of dose-limiting toxicities (DLTs)

Time frame
28 days
2

Safety

Incidence of all treatment-emergent adverse events (TEAEs); Grade 3, 4, 5 TEAEs, serious adverse events (SAEs); deaths due to TEAEs and all deaths

Time frame
2 years
3

Safety

To determine the maximum tolerated dose (MTD) of OPB-101 and/or recommended Phase 1b dose(s)

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Outpace Bio, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now