Ovarian Cancer RecurrentPhase 1NCT07030907
A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer
A Phase 1 study testing OPB-101 in people with Ovarian Cancer Recurrent and Ovarian Cancer, run by Outpace Bio, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer Recurrent, Ovarian Cancer, Platinum Resistant Ovarian Cancer
- What is being tested?
- OPB-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Jun 2025to 15 Oct 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Negative serum pregnancy test.
- Abstain from heterosexual activity or to use 2 forms of effective methods of contraception.
- Note: Other protocol defined inclusion criteria could apply
Who cannot join
- 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.
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- 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.
- Received chemotherapy within the previous 3 weeks.
- History of grade ≥ 3 ascites.
- Active CNS involvement.
- Received a live vaccine within 30 days prior to study treatment.
- Received prior CAR T cell therapy.
- Received prior mesothelin targeted therapy.
- Dependent on intravenous hydration or total parenteral nutrition. Note: Other protocol defined exclusion criteria could apply
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Roswell Park
Buffalo, New York, 14203
Karmanos Cancer Institute
Detroit, Michigan, 48201
MD Anderson Cancer Center
Houston, Texas, 77030
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: A Phase 1a/b Study to Evaluate the Safety and Efficacy of OPB-101, an Autologous Mesothelin (MSLN) CAR T Cell Therapy With Antigen-dependent Expression of OUTSMART™ Designed IL-2 Cytokine in Platinum-resistant Ovarian Cancer
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.
Read the detailed description
A phase 1a/b study to evaluate the safety and efficacy of OPB-101, an autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART™ designed IL-2 cytokine in platinum-resistant ovarian cancer.
- Being tested
- OPB-101
- Keywords
- Outpace, Ovarian cancer, Advanced ovarian cancer, cell therapy, CAR T
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPB-101Biological
An autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART designed IL-2 cytokine
| Study group | Role | What they receive |
|---|---|---|
| OPB-101 Treatment Arm | Experimental | Not described Receives: Biological: OPB-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Incidence of dose-limiting toxicities (DLTs)
Measured: 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
Measured: 2 years
Safety
To determine the maximum tolerated dose (MTD) of OPB-101 and/or recommended Phase 1b dose(s)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start16 Jun 2025
- Primary completion30 Sep 2026
- Study completion15 Oct 2026
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Outpace Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030907
- Sponsor's protocol ID
- OPB-101-OV-101A
- Status last verified
- Oct 2026
- First submitted
- 12 Jun 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/b Study to Evaluate the Safety and Efficacy of OPB-101, an Autologous Mesothelin (MSLN) CAR T Cell Therapy With Antigen-dependent Expression of OUTSMART™ Designed IL-2 Cytokine in Platinum-resistant Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07030907
- Acronym / sponsor ID
- OPB-101-OV-101A
- Keywords
- Outpace, Ovarian cancer, Advanced ovarian cancer, cell therapy, CAR T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Outpace Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A phase 1a/b study to evaluate the safety and efficacy of OPB-101, an autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART™ designed IL-2 cytokine in platinum-resistant ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPB-101 Treatment Arm | Experimental | Biological: OPB-101 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPB-101An autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART designed IL-2 cytokine | Biological | OPB-101 Treatment Arm |
Primary outcome
Safety
Time frame: 28 days
Incidence of dose-limiting toxicities (DLTs)
Safety
Time frame: 2 years
Incidence of all treatment-emergent adverse events (TEAEs); Grade 3, 4, 5 TEAEs, serious adverse events (SAEs); deaths due to TEAEs and all deaths
Safety
Time frame: 2 years
To determine the maximum tolerated dose (MTD) of OPB-101 and/or recommended Phase 1b dose(s)
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OPB-101 in people with Ovarian Cancer Recurrent and Ovarian Cancer, run by Outpace Bio, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.