Endometrial Cancer RecurrentPhase 1NCT07664735
A Phase 1 Study to Evaluate OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
A Phase 1 study testing OPB-201 in people with Endometrial Cancer Recurrent and Endometrial Cancer, run by Outpace Bio, Inc. at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer Recurrent, Endometrial Cancer, Advanced Endometrial Cancer
- What is being tested?
- OPB-201
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Jun 2026to Sep 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 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.
- Measurable disease.
- Consent to provide archived tumor tissue sample.
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- ECOG performance status of 0 or 1.
- Adequate organ function.
- HLA-A *02:01 or HLA-A *02:02
- PRAME positive tumor
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.
- Other exclusions as stated in the protocol.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Emory - Winship Cancer Institute
Atlanta, Georgia, 30322
Molly Stoddart, 404-778-6547, molly.stoddart@emoryhealthcare.org
Jennifer Scalici, MD
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Anh Trinh, 313-576-9298, trinha@karmanos.org
Radhika Gogoi, MD
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Kelly Rangal, 713-444-4865, kshea@mdanderson.org
Amir Jazaeri, MD
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Melissa Geller, M.D., 612-624-2620, ccinfo@umn.edu
Melissa Geller, MD
- Recruiting
UCSF - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143
Colan Tizon, 415-307-1067, Colan.Tizon@ucsf.edu
David Oh, MD
About this study
Official title: A Phase 1a/b Study to Evaluate the Safety and Efficacy of OPB 201, an Autologous PReferentially Expressed Antigen of MElanoma (PRAME) T Cell Receptor (TCR) T Cell Therapy in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
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.
Read the detailed description
A phase 1a/b study to evaluate the safety and efficacy of OPB-201, an autologous PReferentially expressed Antigen of MElanoma (PRAME) T cell receptor (TCR) T cell therapy in recurrent endometrial and platinum-resistant ovarian cancer.
- Conditions
- Endometrial Cancer Recurrent, Endometrial Cancer, Advanced Endometrial Cancer, Ovarian Cancer, Ovarian Cancer Recurrent, Platinum Resistant Ovarian Cancer
- Being tested
- OPB-201
- Keywords
- Outpace, Ovarian cancer, Endometrial cancer, advanced ovarian cancer, advanced endometrial cancer, cell therapy, TCR-T, TCR, PRAME directed TCR
- Medical subject headings
- Endometrial Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPB-201Biological
A multi-transgene autologous TCR T cell therapy with optimized alpha and beta chains of a TCR specific for a peptide derived from PRAME and a designed protein which enhances TCR T cell potency.
| Study group | Role | What they receive |
|---|---|---|
| OPB-201 Treatment Arm | Experimental | OPB-201 Treatment Arm Receives: Biological: OPB-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all treatment-emergent adverse events (TEAEs); Grade 3, 4, 5 TEAEs, serious adverse events (SAEs); deaths due to TEAEs and all deaths.
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
Incidence of dose-limiting-toxicities (DLTs)
Incidence of dose-limiting-toxicities (DLTs)
Measured: 28 days
To determine the maximum tolerated dose (MTD) of OPB-201 and/or recommended Phase 1b dose(s)
To determine the maximum tolerated dose (MTD) of OPB-201 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 posted24 Jun 2026
- Study start30 Jun 2026
- Primary completionJun 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial 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
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Outpace Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664735
- Sponsor's protocol ID
- OPB-201-BSKT-101A
- Status last verified
- Oct 2026
- First submitted
- 17 Jun 2026
- 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 201, an Autologous PReferentially Expressed Antigen of MElanoma (PRAME) T Cell Receptor (TCR) T Cell Therapy in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
- ClinicalTrials.gov ID
- NCT07664735
- Acronym / sponsor ID
- OPB-201-BSKT-101A
- Conditions
- Endometrial Cancer Recurrent, Endometrial Cancer, Advanced Endometrial Cancer, Ovarian Cancer, Ovarian Cancer Recurrent, Platinum Resistant Ovarian Cancer
- Keywords
- Outpace, Ovarian cancer, Endometrial cancer, advanced ovarian cancer, advanced endometrial cancer, cell therapy, TCR-T, TCR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Outpace Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 24 Jun 2026 (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-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.
Detailed description
A phase 1a/b study to evaluate the safety and efficacy of OPB-201, an autologous PReferentially expressed Antigen of MElanoma (PRAME) T cell receptor (TCR) T cell therapy in recurrent endometrial and platinum-resistant ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| OPB-201 Treatment Arm | Experimental | Biological: OPB-201OPB-201 Treatment Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Measurable disease.
Key exclusion criteria (10 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-201A multi-transgene autologous TCR T cell therapy with optimized alpha and beta chains of a TCR specific for a peptide derived from PRAME and a designed protein which enhances TCR T cell potency. | Biological | OPB-201 Treatment Arm |
Primary outcome
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
Incidence of all treatment-emergent adverse events (TEAEs); Grade 3, 4, 5 TEAEs, serious adverse events (SAEs); deaths due to TEAEs and all deaths.
Incidence of dose-limiting-toxicities (DLTs)
Time frame: 28 days
Incidence of dose-limiting-toxicities (DLTs)
To determine the maximum tolerated dose (MTD) of OPB-201 and/or recommended Phase 1b dose(s)
Time frame: 2 years
To determine the maximum tolerated dose (MTD) of OPB-201 and/or recommended Phase 1b dose(s)
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
5 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-201 in people with Endometrial Cancer Recurrent and Endometrial Cancer, run by Outpace Bio, Inc. at 5 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 10 inclusion and 10 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: looking for participants now, 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 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Ferraro (3039290208, jferraro@outpacebio.vom), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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.