Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05397093 | ITIL-306 in Advanced Solid Tumors | PHASE1 | TERMINATED | 1 | — | — | Aug 24, 2022 | Mar 6, 2026 | Apr 15, 2026 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| Phase 1a: Dose Escalation | EXPERIMENTAL | Various doses will be tested in participants with EOC, NSCLC and RCC. |
| Phase 1b: Expansion | EXPERIMENTAL | Cohort 1: Participants with epithelial ovarian cancer (EOC) Cohort 2: Participants with non-small cell lung cancer (NSCLC) Cohort 3: Participants with renal cell carcinoma (RCC) |
| Name | Type | Description |
|---|---|---|
| ITIL-306 | BIOLOGICAL | ITIL-306 is a cell therapy product derived from a participant's own TILs and contains a unique molecule designed to increase TIL activity when it encounters FOLR1 on the tumor. A portion of the participant's tumor is surgically removed to make a personalized ITIL-306 product. Once ITIL-306 has been made, the participant is treated with 3 days of lymphodepleting chemotherapy including cyclophosphamide and fludarabine, followed by 2 days of rest then a single infusion of ITIL-306. |
Key Inclusion Criteria: * Histologically documented advanced (metastatic and/or unresectable) disease as appropriate per cohort. * Phase 1a Dose Escalation: High-grade serous epithelial carcinoma of the ovary, fallopian tube, or peritoneum, adenocarcinoma of the lung, or clear-cell renal cell ca...