Clinical Trial

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.

Study acronym: PROTA
Active, Not Recruiting Phase 1/2
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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.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2022-03-02; most recent amendment 2026-04-29.
Status change: Recruiting → Active, Not Recruiting 2026-04-29
Status change: Not Yet Recruiting → Recruiting 2022-05-30
Trial Details
NCT Number NCT05271318
Lead Sponsor TILT Biotherapeutics Ltd.
Collaborators: Merck Sharp & Dohme LLC
Conditions Platinum-refractory Ovarian Carcinoma, Platinum-resistant Ovarian Cancer, Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, Platinum-Refractory Fallopian Tube Carcinoma, Platinum-Refractory Primary Peritoneal Carcinoma, Platinum-Sensitive Ovarian Cancer in Which the Participant Has Allergy or Severe Intolerance to Carboplatin and/or Cisplatin, Platinum-Sensitive Fallopian Tube Carcinoma in Which the Participant Has Allergy or Severe Intolerance to Carboplatin and/or Cisplatin +1 more
Enrollment 29 participants
Start Date 2022-05-17
Primary Completion 2027-03 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-05-05