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.
| NCT ID | NCT05271318 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | TILT Biotherapeutics Ltd. |
| Condition | Platinum-refractory Ovarian Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2022-05-17 |
| Primary Completion | 2027-03 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: * 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: 1. Phase I part: Histologically confirmed ovarian cancer (including fallopian tube and primary peritoneal cancer) resistant to platinum (defined as progression of cancer within 183 days of the most recent dose of cisplatin or carboplatin) or refractory to platinum (defined as progression of cancer within 30 days of the most recent dose of cisplatin or carboplatin) ovarian cancer, which cannot be treated with curative intent with available therapies. 2. Phase Ib part: Platinum refractory/resistant ovarian cancer treated with up to one line of prior chemotherapy in refractory/resistant setting. Note: A regimen that contains only one or more biological agents and/or targeted therapies but no cytotoxic drug does not count as a line of chemotherapy Note: For both phase I an