Phase 1/1b TILT-123 with Pembrolizumab for Ovarian Cancer
This study is testing the safety of a new treatment combination for ovarian cancer that has come back or not responded to platinum-based chemotherapy. The treatment involves TILT-123, a virus designed to fight cancer and boost the immune system, given either with pembrolizumab (an immunotherapy that helps your immune system find and kill cancer cells) or with pembrolizumab and pegylated liposomal doxorubicin (a chemotherapy drug). Researchers want to see how many side effects participants experience. This is a Phase 1/1b study, meaning it's an early-stage trial focused on safety. About 29 women aged 18 or older with platinum-resistant or refractory ovarian, fallopian tube, or primary peritoneal cancer can join. The study is currently recruiting, but its overall status is unclear.
- Study design
- This is an open-label, Phase 1/1b study, meaning you and your doctors will know which treatments you are receiving. It plans to enroll about 29 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures side effects and vital signs up to Day 92 after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05271318
Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab (Phase 1a) and Pegylated Liposomal Doxorubicin (Phase 1b) as Treatment for Ovarian Cancer.
Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatmentTILT Biotherapeutics Ltd.
~29 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:TILT-123pembrolizumabpegylated liposomal doxorubicin
At a glance
Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with any (serious and non-serious) Adverse Events
Measured over Day 92
+3 more outcomes measured
Conditions
Where it's being run
3 sites across 3 statesMinnesota1
New York1
Finland1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Signed and dated informed consent(s) by the participant or legal representative before any trial-related activities.
Female over 18 years of age on day of signing informed consent(s).
Diagnosis:
At least one tumor (\>14 mm in diameter) or carcinomatosis must be available for local virus injection (intratumoral and/or intraperitoneal).
The disease burden must be evaluable, but does not need to fulfil RECIST 1.1.
Have adequate organ function as defined in the following values below. Specimens must be collected within 10 days prior to the start of study treatment.
Patients must be willing to use adequate forms of contraception from screening, during the trial, and for a minimum of 120 days after end of treatment, in accordance with the following:
Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance score of 0-1 at screening.
Life expectancy longer than 3 months.
Capable of understanding and complying with parameters as outlined in the protocol.
Exclusion
Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) and inhaled and topical treatments are not considered a form of systemic treatment and are allowed.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
Prior therapy:
Participants must have recovered from all Adverse Events (AE)s due to previous therapies to ≤Grade 1or baseline. Participants with ≤Grade 2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible. If the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention.
Treated with a prior radiotherapy, including for palliative purposes, within 2 weeks of start of study treatment (before or after). Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-Central Nervous System (CNS) disease. Palliative radiation is allowed from day 15 during the trial treatment period, if deemed necessary by the investigator.
Treated with a prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., Cytotoxic T lymphocyte-associated Antigen (CTLA)-4, Tumor necrosis factor receptor superfamily, member 4 (OX40), CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related Adverse Events (irAE).
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 30 days prior to the first virus injection. An investigational agent is any drug or therapy that is currently not approved for use in humans. Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
Uncontrolled cardiac or vascular diseases.
History of myocardial infarction or cerebral stroke within the previous 12 months before screening or is not sufficiently recovered from an older infarction or cerebral stroke.
History of severe hepatic dysfunction.
History of hepatitis B (defined as HBsAg reactive), Hepatitis C (defined as hepatitis C virus (HCV) RNA \[qualitative\] is detected) and/or HIV. No testing for Hepatitis B, Hepatitis C and HIV is required unless mandated by a local health authority.
History of coagulation disorder.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Female patients who are pregnant, breastfeeding or intend to become pregnant. Women of childbearing potential who has a positive urine pregnancy test (within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 3 months by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
Has an active infection requiring systemic therapy.
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
Allergy to ingredients present in the investigational medicinal products (ingredients are listed in the protocol) ie. severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Known contraindications to pembrolizumab.
Has had an allogenic tissue/solid organ transplant.
Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines are allowed.
What this trial measures
- Number of Participants with any (serious and non-serious) Adverse EventsDay 92
- Number of Participants with vital sign abnormalitiesDay 92
- Number of Participants with abnormal laboratory valuesDay 92
- Number of Participants with Adverse Events assessed by electrocardiograms (ECGs)Day 92