NCT07030907

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
49mo left

Started Jun 2025

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Jun 2025May 2030

First Submitted

Initial submission to the registry

June 12, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

June 16, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2030

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

2.9 years

First QC Date

June 12, 2025

Last Update Submit

December 11, 2025

Conditions

Ovarian Cancer RecurrentOvarian CancerPlatinum Resistant Ovarian Cancer

Keywords

OutpaceOvarian cancerAdvanced ovarian cancercell therapyCAR T

Outcome Measures

Primary Outcomes (3)

  • Safety

    Incidence of dose-limiting toxicities (DLTs)

    28 days

  • 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

    2 years

  • Safety

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

    2 years

Study Arms (1)

OPB-101 Treatment Arm

EXPERIMENTAL
Biological: OPB-101

Interventions

OPB-101BIOLOGICAL

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

OPB-101 Treatment Arm

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 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.
  • +2 more criteria

You may not qualify 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.
  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Roswell Park

Buffalo, New York, 14203, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

John Ferraro, MBA

CONTACT

3039290208clinicaltrials@outpacebio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2025

First Posted

June 22, 2025

Study Start

June 16, 2025

Primary Completion (Estimated)

May 15, 2028

Study Completion (Estimated)

May 15, 2030

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(4)