RecruitingPhase 1Phase 2NCT05271318

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.

A Two-part, Phase I/Ib, Open-Label, Dose-escalation Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus (TILT-123) in Combination With Pembrolizumab (Phase I Part) and Pembrolizumab and Pegylated Liposomal Doxorubicin (Phase Ib Part) in Patients With Platinum Resistant or Refractory Ovarian Cancer


Sponsor

TILT Biotherapeutics Ltd.

Enrollment

29 participants

Start Date

May 17, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, phase 1/1b, dose-escalation, multicenter and multinational trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with Pembrolizumab, or Pembrolizumab and Pegylated Liposomal Doxorubicin in patients with platinum resistant or refractory ovarian cancer.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a virus-based treatment (TILT-123) combined with the immunotherapy drug pembrolizumab, or combined with a chemotherapy drug (liposomal doxorubicin), for women with ovarian cancer that has stopped responding to standard platinum-based chemotherapy. **You may be eligible if...** - You are a woman over 18 with confirmed ovarian, fallopian tube, or primary peritoneal cancer - Your cancer stopped responding to or progressed during platinum chemotherapy - You have received no more than one prior chemotherapy regimen in the platinum-resistant/refractory setting (for Phase Ib) - You are willing and able to consent **You may NOT be eligible if...** - Your cancer still responds to platinum chemotherapy - You have had more lines of prior chemotherapy than allowed - You have serious organ dysfunction or uncontrolled infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTILT-123

Tumor necrosis factor alpha (TNFalpha) and Interleukin-2 (IL-2) coding oncolytic adenovirus TILT-123

BIOLOGICALpembrolizumab

pembrolizumab, a monoclonal antibody binding PD-1

DRUGpegylated liposomal doxorubicin

Pegylated Liposomal Doxorubicin is a chemotherapy and a pegylated liposomal form of the anthracycline topoisomerase inhibitor, doxorubicin.


Locations(3)

Mayo Clinic

Rochester, Minnesota, United States

Northwell Heatlh/Lenox Hill Hospital

New York, New York, United States

Docrates Cancer Center

Helsinki, Finland

View Full Details on ClinicalTrials.gov

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NCT05271318


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